RAW MATERIAL DOCUMENTATION

FOR.05.06 rev.2

4176000G – CALENDULA - ECO¹

Version: 21 - 23/08/2010

Exclusive N.A. Distributor

CENTERCHEM, INC. NORWALK, CT
Ph: 203-822-9800 Fax: 203-822-9820
www.centerchem.com
1. PRODUCT IDENTIFICATION
Trade Name: CALENDULA - ECO¹
Manufacturer: PROVITAL,S.A.
Responsible for the Safety Assessment: Lourdes Mayordomo
Tf./Fax: 3493-7192350/7190294
e-mail: l.mayordomo@provitalgroup.com
Kind of Raw Material: Active Ingredient
Function of the Ingredient (CTFA Handbook): Fragrance Ingredients; Skin-Conditioning Agents -
Miscellaneous
Function of the Ingredient (UE Inventory): Masking, Perfuming, Skin conditioning
Maximum Suggested Concentration: 100 %
INCI approved in: Registered in EU, USA, Japan
Japanese Name: Calendula Extract

2. PRODUCT COMPOSITION
Components Breakdown (INCI). Including actives, solvents,
solvents, preservatives, antioxidants
antioxidants and other
additives:
dditives:

[EU] CAS EINECS

Glycerin 40 - 60 % 56-81-5 200-289-5
Aqua 40 - 60 % 7732-18-5 231-791-2
Calendula Officinalis Flower Extract 1,5 - 3,5 % 84776-23-8 283-949-5
Preservatives
Potassium Sorbate 0,2 - 0,3 % 24634-61-5 246-376-1
Sodium Benzoate 0,2 - 0,3 % 532-32-1 208-534-8
-------------------------------------------------------------------------------------------------------------
PCPC [CTFA] CAS EINECS
Glycerin 40 - 60 % 56-81-5 200-289-5
Water 40 - 60 % 7732-18-5 231-791-2
Calendula Officinalis Flower Extract 1,5 - 3,5 % 84776-23-8 283-949-5
Preservatives
Potassium Sorbate 0,2 - 0,3 % 24634-61-5 246-376-1
Sodium Benzoate 0,2 - 0,3 % 532-32-1 208-534-8

Impurities:
Heavy Metals (as Pb) Less than 20 ppm.
Pesticides No data available. Not expected to be found.

3. TOXICOLOGICAL INFORMATION
Data obtained in our own toxicological tests and/or bibliographical research
Animal testing:
This product has not been the subject of animal testing or retesting for cosmetic purposes by or on
behalf of this company.
General information:
The following herbs have been approved by the German Commission E Monographs: Calendula
Flower (Published March 13, 1986)
American Herbal Products Association: Calendula officinalis flower - Herbs that can be safely

This information agrees with the current state of our knowledge and is based on our experience and in sources that we believe to be creditable. It
does not imply any responsibility for damages, losses or expenses derived from the handling, storage, use or elimination of the product. It does not
exempt of the obligation of the client to guarantee the safety of its product.
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FOR.05.06 rev.2

4176000G – CALENDULA - ECO¹

Version: 21 - 23/08/2010

consumed when used appropriately (Class 1)

The CIR Expert Panel concluded that Calendula Officinalis Extract, Calendula Officinalis Flower,
Calendula Officinalis Flower Extract, Calendula Officinalis Flower Oil, and Calendula Officinalis Seed Oil
are safe for use in cosmetics.(Final Report. Amended Safety Assessment of Calendula Officinalis,
March 23,2009)
The following substances have the GRAS status("Generally Recognized As Safe"): Glycerin
(21CFR182.1320)
It exists a CIR Final Report on Safety Assessment of Potassium Sorbate including all the toxicological
data: JACT 7(6): 837-80, 1988, confirmed 04/06.
It exists a CIR Final Report on Safety Assessment of Sodium Benzoate including all the toxicological
data: IJT, 20(S3):23-50, 2001, reopened 06/10.
Classification according to Council of Europe (*):
3
*(1)- Non-recommended ingredients (2)-Ingredients which could not be assessed (3) –Recommended
ingredients
Cytotoxicity:
In a study of cytotoxicity using 5 extract of C. officinalis on mouse Ehrlich ascites carcinoma, the results
reported that one extract had no effect on tumor growth, trhee extracts were minimally effective in
limiting tumor growth and the 5th extract was effective in curtailing tumor growth. (Final Report.
Amended Safety Assessment of Calendula Officinalis, March 23,2009)
Skin Irritation:
Test done with other products from Provital: (Cod.4230) Patch Test (30 h), IP = 0% Patch Test (48 h),
IP = 0%; SKINTEX (UMA) : 2.14 Mild / Moderate
Several calendula preparations in patch tests assays in volunteers showed unimportant effects of
dermic irritation. (The essential guide to herbal safety, Elsevier, First editon, 2005, pp 310)
Differents skin test in animals whit extracts of Calendula officinalis classified the different extracts as
non-irritant.(Final Report. Amended Safety Assessment of Calendula Officinalis, March 23,2009)
Glycerin (RTECS nºMA8050000): Draize Test in the skin of rabbit , 500 mg, 24 h, Mild
Skin Sensitization:
Differents studies of Dermal sensitazion in volunteers using Calendula officinalis concluding that C.
officinalis was not considered a sensitizer. (Final Report. Amended Safety Assessment of Calendula
Officinalis, March 23,2009)
Calendula officinalis showed no sensitization effects in animal tests ( Int. J. Toxicol. 2001;20 Suppl
2:13-20)
Eye Irritation:
Test done with other products from Provital: Calendula-Extract H.G. (4230): In-vitro Irritation Index
(HET-CAM) = 2.2 (sol. 2%), 4.62 (sol. 100%)
Draize test whit different extracts of Calendula officinalis were not irritating to rabbit eyes. (Final Report.
Amended Safety Assessment of Calendula Officinalis, March 23,2009)
An oily extract of Calendula is tolerable to mucosa in the Draize primary mucosa irritation test using the
rabbit eye (ESCOP,1,1996)
Glycerin (RTECS no.:MA8050000): Draize Test eye rabbit= 500 mg/24h, mild
Mutagenicity:
Calendula flower saponins: Ames Test ( TA98, +/- S9), negative (MUTA 5, 327-31,90)
Calendula flower extract: Not carcinogenic in rat ( p.o., 0.15 g/kg, 22 months) and hamster (p.o., 0.15
g/Kg, 18 months) (MEBIIN4,28-32,88)
An Ames test of 6 saponins isolated from the dried flowers of Calendula officinalis using Salonella
typhimurium TA98 did not show increase in mutation frequency. (Final Report. Amended Safety
Assessment of Calendula Officinalis, March 23,2009)
Somatic an recombination assays using Drosophila melanogaster exposed to C. officinalis herbal tea
extract did not show increase in mutation frequency.(Final Report. Amended Safety Assessment of

This information agrees with the current state of our knowledge and is based on our experience and in sources that we believe to be creditable. It
does not imply any responsibility for damages, losses or expenses derived from the handling, storage, use or elimination of the product. It does not
exempt of the obligation of the client to guarantee the safety of its product.
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Calendula Officinalis, March 23,2009)

Calendula officinalis extract (RTECSnºEW7491000): Genetic conversion and mitotic recombination in
Aspergillus nidulans, 0.1g/L/72h
Fluid extract of Calendula:negative in Ames Test at 50-5000ug/plate (+/- S9) and negative in
micronucleous test in mouse at 1g/kg p.o. (JEtn 1998 61(1):49-55)
Isorhamnetin: (RTECS no.LK9275450): mutation in Salmonella typhimurium: 1mg/plate
Glycerin: DNA inhibition in human lymphocyte, 200 mmol/l (PNASA 6 79, 1171, 1982) Cytogenic
Analysis rat p.o., 1 g/Kg (TGANAK 19, 436, 1985)
Acute toxicity:
Aqueous extract from Calendula flower (ESCOP ,2nd ed. 2003): LD100 i.p. in mouse: 580 mg/kg; LD50
i.v. mouse 375 mg/kg
Calendula officinalis flower extract: i.p. LD50 in mice = 300mg/kg. (Final Report. Amended Safety
Assessment of Calendula Officinalis, March 23,2009)
In a study of the acute effeccts of a hidrohalcol extract of flowers of Calendula officinalis in rats and
mice; it were administred oral doses at 0.625-5.0g/kg. No deaths or moridity were found in the control
group or the treatment group. (Final Report. Amended Safety Assessment of Calendula Officinalis,
March 23,2009)
A study in which groups of mice were given a mixture of Calendula officinalis flower extract, butylene
glycol, and water daily for 14 days at 5-20ml/kg. No animals died and the LD50 was >20ml/kg.(Final
Report. Amended Safety Assessment of Calendula Officinalis, March 23,2009)
Hydroalcohol extract of calendula: LD50 > 5g/kg p.o. in rat and mouse. (Phytother Res. 2007, Apr;
21(4):332-6.]
Calendula extract: LD50 p.o., rat > 4.6 g/kg (The essential guide to herbal safety, Elsevier, First editon,
2005, pp 310).
Hydro-alcoholic extracts from Calendula flower showed a LD50 of 45mg/mouse(s.c.) and a LD50 of
526 mg/100g in rat (i.v.)(ESCOP,1,1996)
An ethylene glycol extract of Calendula is non-toxic in albino mice after subcutaneous administration of
10ml/kg (ESCOP,1,1996)
Calendula extracts tested for acute and chronic toxicity studies in animals at doses higher than
50mg/kg showed no histophatological changes or toxicity simptoms. (Tratado de Fitofármacos y
Nutracéuticos; Dr. Jorge Alonso, pag 254)
Isorhamnetin. (RTECS no.LK9275450): LD50 i.v. rat = 11.1g/Kg
Glycerin (RTECS nº MA8050000): LD50 in rat : p.o.=12600 mg/kg, i.p.=4420 mg/kg, s.c.=100 mg/kg,
i.v.=5566 mg/kg. LDLo in rat i.m. =10 mg/kg, TDLo in rat i.m.=5 g/kg
Glycerin (RTECS nºMA8050000): TDLo oral in human = 1428 mg/kg
Glycerin (RTECS nº:MA8050000): LD50 oral mouse= 4090 mg/kg, LD50 i.p. mouse= 8700 mg/kg,
LD50 s.c. mouse= 91 mg/kg, LD50 i.v. mouse= 4250 mg/kg, LD50 oral rabbit= 27 gm/kg, LD50 i.v.
rabbit= 53 gm/kg, TDLo i.m. rat= 4 mL/kg, TDLo i.m. rat= 4000 mg/kg
Subchronic and chronic toxicity:
No symptoms of toxicity have been found after administration of a Calendula flower extract at 0.15 g/kg
to hamsters over 18 months and to rats over 21 months (ESCOP,1,1996)
Hydroalcoholic extract of calendula tested in subacute studies in rat and mouse at doses up to 1g/kg
was non-toxic, although theres was evidence of renal and liver effects. (Phytother Res. 2007, Apr;
21(4):332-6.]
The aqueous extract of Calendula is not toxic in chronic administration to mice (ESCOP,1,1996)
Glycerin (RTECS no:MA8050000): TDLo oral rat= 96 gm/kg/30D-I, TDLo oral mouse= 560 gm/kg/8W-
C, TDLo oral mouse= 2800 mg/kg/25W-C
Reproductive effects:
Pregnancy category B2: no increase in frequency of malformation or other harmful effects on the foetus
from limited use in women. Animal studies are lacking (The Essential Guide to Herbal Safety, Simon
Mills and Kerry Bone, Elsevier, First edition 2005, pp 309-311).

This information agrees with the current state of our knowledge and is based on our experience and in sources that we believe to be creditable. It
does not imply any responsibility for damages, losses or expenses derived from the handling, storage, use or elimination of the product. It does not
exempt of the obligation of the client to guarantee the safety of its product.
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Glycerin:(RTECS nº MA8050000) rat, i.t. TDL0 = 280 mg/Kg, 2 Days, male ; rat o. TDL0=100 mg/Kg, 1
Day, male ;rat, i.t., TDL0=862 mg/Kg, 1 Day, male
Other data:
A study of phototoxicity with a mixture of Calendula officinalis flower extract, Butylene glycol, and water
using guinea pigs showered that Calendula Officinalis flower extract mixture did not produced
phototoxicity (Final Report. Amended Safety Assessment of Calendula Officinalis, March 23,2009)
The use of Calendula officinalis L. is compatible with breastfeeding (The Essential Guide to Herbal
Safety, Simon Mills and Kerry Bone, Elsevier, First edition 2005, pp 309-311).
Calendula officinalis showed no phototoxic effects in animal tests ( Int. J. Toxicol. 2001;20 Suppl 2:13-
20)
Glycerin (RTECS nº MA8050000): LC50 rat inhalation > 570/mg/m3/1H
Glycerin (RTECS nºMA8050000): TDLo oral in human = 1428 mg/kg

4. ECOLOGICAL DATA
Biodegradability:
Biodegradability:
Glycerin (HSDB nº492,Revision:20050624).Activated sludge test:220 mg/l resulted in a COD of
97%;Test in a 5 days:BOD= 82%. Glycerin is considered a substance easily degraded
Aquatic Toxicity:
Toxicity:
Glycerin:Inhibition multiplication test in algae (Microcystis aeruginosa) and protozoa (Entosiphon
sulcatum) Toxicity threshold=2900 mg/l and 3200 mg/l (HSDB nº492,Revision:20050624)
Glycerin (HSDB nº492,Revision:20050624):LC50 goldfish > 5000 mg/l/24 h
Other data:
data:
No data available.

5. CONCLUSION
The components of this product have registered adverse effects neither in its traditional uses nor in the
historical marketing of this company. These data and the available toxicological information lead to the
conclusion that the use of this product, under the normal conditions of cosmetic use and at the
maximum recommended concentration, involves no risk for consumers.

This information agrees with the current state of our knowledge and is based on our experience and in sources that we believe to be creditable. It
does not imply any responsibility for damages, losses or expenses derived from the handling, storage, use or elimination of the product. It does not
exempt of the obligation of the client to guarantee the safety of its product.
4