Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study by the oral route does not need to be conducted because an appropriate dermal study is available and dermal is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
assessment report
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
23/04 - 25/04/2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING - please see attached bellow
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Cosmetic Product Tes Guidelines for Assessment of Human Skin Compatibility
Version / remarks:
COLIPA, Bruxelles 1995
Qualifier:
according to guideline
Guideline:
other: International Ethical Guidelines for Biomedical Research Involving Human Subjects
Principles of method if other than guideline:
For ingredietns, that are toxicological relevant, the Systemic Exposure Dose, SED). SED of the relevant ingredience is the amount, that can get into the bloodstream (and can has the systematic effect). Systemic availability depends on the dermal absorption. It there is no relevant data on absorption of the certain ingredients, it is presume that the ingredience is fully absorbed (100%).
SED(ingr derm) =SEDproduct(A) (mg/kg/d) x Concingr(C)(%) x Dermal absorption(P)(%)
The Margin of Safety (MOS) is required for toxicological relevant ingredience. It can generally be told, that MOS value should be > 100 to presume the safe use. The relevant data must be used for the MOS calculation. therefore the NOAEL is used for the calculation. If there is no relevant data on subacute or subchronic toxicity, it is presumed that NOAEL is 1% of LD50 value. If the substance is not classified as Acute Tox.or health harmful, the LD50 value is > 2000 mg/kg and NOAEL is supposed to be 20 mg/kg/d according to criteria for classification of hazardous chemical substances.
MOS(Ingredience) = NOAEL(Ingredience) / SED (ingredience)
GLP compliance:
not specified
Type of study:
not specified
Species:
other: human
Sex:
male/female
Details on test animals and environmental conditions:
Adult (women and men) and children
Average body weight: 60 kg
All skin types
Vehicle:
not specified
Concentration:
SED = 16.7 mg/kg/bw
(SED is calculated according to The SCCS's Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation, 8th Revision, Scientific Committee on Consumer SAfety, SCCS 1501/12).
Details on study design:
- Amount: 10 g per one application per day
- Application area: the surface of the skin of the palm of the hand
- Retention factor: 0.1
- Exposion: 1h
- Duration time: once per day
Positive control substance(s):
not specified
Positive control results:
N/A
Key result
Parameter:
SI
Value:
248
Test group / Remarks:
adutl (women and men)
Remarks on result:
other: SED
Parameter:
SI
Value:
0
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
On the conditions of the performed test, no reaction in terms of erythema, oedema or scaliness has been observed in the subjects.
Executive summary:

If the tested item is used by healthy persons under normal or normally foreseeable conditions and according to the instructions for use does not present a risk of irritation, sensitization or other local or systemic, toxicological adverse effects. Composition of the product complies with the requirement of Regulation (EU) no 1223/2009 on cosmetic products.

Reason / purpose for cross-reference:
assessment report
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23/04 - 25/04/2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: Cosmeticproduct Test Guidelines for Assessment of Human Skin Compatibility
Version / remarks:
COLIPA, Bruxelles 1995.
Deviations:
no
GLP compliance:
not specified
Irritation parameter:
erythema score
Basis:
other: human
Time point:
24 h
Max. score:
0
Reversibility:
not reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other: human
Time point:
24 h
Max. score:
0
Reversibility:
not reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
other: human
Time point:
48 h
Max. score:
248
Reversibility:
not reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other: human
Time point:
48 h
Max. score:
248
Reversibility:
not reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Time point:
72 h
Max. score:
0
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Time point:
72 h
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
The test has been carried out according to the Cosmetic Product test Guidelines for Assessment of Human Skin Compatibility, COLIPA, Brussels 1995.

The test has been carried out with the approval of Ethics Committee of the National Institute of Public Health. The selection of subjects and the testing procedure is goerned by the principles laid down in the International Ethical Guidelines for Biomedical Research Involving Human Subjects and has been carried on a voluntary basis. 15 persons aged between 25 and 67 years participated in the test.

On the conditions of the test, no reaction in terms of erythema, oedema or scaliness has been observed in the subjects.
Executive summary:

The test has been carried out according to the Cosmetic Product test Guidelines for Assessment of Human Skin Compatibility, COLIPA, Brussels 1995.

The test has been carried out with the approval of Ethics Committee of the National Institute of Public Health. The selection of subjects and the testing procedure is goerned by the principles laid down in the International Ethical Guidelines for Biomedical Research Involving Human Subjects and has been carried on a voluntary basis. 15 persons aged between 25 and 67 years participated in the test.

On the conditions of the test, no reaction in terms of erythema, oedema or scaliness has been observed in the subjects.

Data source

Materials and methods

Test animals

Sex:
male/female

Results and discussion

Applicant's summary and conclusion