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Diss Factsheets

Administrative data

Description of key information

The skin sensitization potential of test chemical was assessed in various experimental studies conducted on human subjects. Based on the available data for the test chemical and supporting studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “non Skin Sensitizer”.

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by performing patch tests on humans.
GLP compliance:
not specified
Type of study:
other: 2.guinea pig maximisation test 3.patch test
Species:
other: 2.guinea pig 3.humans
Strain:
other: 2.Hartley 3.Not applicable.
Sex:
not specified
Details on test animals and environmental conditions:
2. No data available.
Route:
intradermal
Vehicle:
not specified
Remarks:
2.
Concentration / amount:
Test material diluted in FCA(0.1-mL injections of FCA)
Route:
epicutaneous, occlusive
Vehicle:
other: eyeshadow formulation
Remarks:
3.
Concentration / amount:
10% in eyeshadow formulation
Adequacy of induction:
not specified
No.:
#1
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Remarks:
2.
Concentration / amount:
0.0025% (undiluted test material)
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: eyeshadow formulation
Remarks:
3.
Concentration / amount:
10 % in eyeshadow formulation
Adequacy of challenge:
not specified
No. of animals per dose:
2.
Total 14 animals
10 test group
2 positive control
2 Negative control.

3.
99 human volunteers
Details on study design:
2.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: No data available.
- Test groups: 10
- Control group: 4
- Site: Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body.
- Frequency of applications: No data available.
- Duration: No data available.
- Concentrations: Test material diluted in FCA(0.1-mL injections of FCA,)

B. CHALLENGE EXPOSURE
- No. of exposures: No data available.
- Day(s) of challenge: No data available.
- Exposure period: No data available.
- Test groups: 10
- Control group: 4
- Site: Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body.
- Concentrations: undiluted test material
- Evaluation (hr after challenge): No data available.

Other- Skin sensitization reaction were scored.

3.
Each subject was then examined at baseline and one, two, three, and four weeks after application.
Challenge controls:
2. Negative controls received distilled water
3. no data available
Positive control substance(s):
yes
Remarks:
2. 5% formalin 3.not specified
Positive control results:
2. The 2 positive control animals received scores of 3.
Reading:
other: 2. challenge
Group:
test chemical
Dose level:
0.0025% (undiluted test material)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin sensitization reaction observed.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
99
Clinical observations:
The eye shadow formulation did not cause any dermal reactions to 99 volunteers tested.
Remarks on result:
no indication of skin sensitisation
Remarks:
3.

2.

There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0.

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical was considered to be not sensitizing to the skin on the basis of summarized studies.
Executive summary:

Data available for the test chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:

The skin sensitizing test for test chemical was observed in Guinea pig by Guinea pig maximisation test. Group of 10 Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body. The test guinea pigs received two 0.1-mL injections of FCA, test material diluted in FCA in induction phase. While at challenge 0.0025% undiluted test material were given intradermally to 10 animals. Negative controls received distilled water and positive controls received 5% formalin. There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0. Under the conditions of the study, the makeup foundation containing 0.05% and 0.0025% of test chemical was not a sensitizer. Therefore the test chemical was considered to be non-sensitizing in Guinea pig .

Moreover,Draize Shelanski Patch test was performed to evaluate the dermal sensitization potential of test chemical present in an eye shadow formulation.The eye shadow formulation containing 10% test chemical was exposed to the skin of 99 human volunteers, and observed for dermal reactions (duration of exposure, observation period not specified).The eye shadow formulation didnot cause any dermal reactions to 99 volunteers tested.Hence,the eye shadow formulation containing 10% test chemical can be considered to be not sensitizing to human skin.

Based on the above summarized studies for target chemical ,it can be concluded that the test chemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Data available for the test chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:

The skin sensitizing test for test chemical was observed in Guinea pig by Guinea pig maximisation test. Group of 10 Hartley guinea pigs were clipped free of hair on the anterior dorsal region of the body. The test guinea pigs received two 0.1-mL injections of FCA, test material diluted in FCA in induction phase. While at challenge 0.0025% undiluted test material were given intradermally to 10 animals. Negative controls received distilled water and positive controls received 5% formalin. There were no reactions in any of the 10 test guinea pigs. The 2 positive control animals received scores of 3 and the negative control animals had no erythema and received scores of 0. Under the conditions of the study, the makeup foundation containing 0.05% and 0.0025% of test chemical was not a sensitizer. Therefore the test chemical was considered to be non-sensitizing in Guinea pig .

Moreover,Draize Shelanski Patch test was performed to evaluate the dermal sensitization potential of test chemical present in an eye shadow formulation.The eye shadow formulation containing 10% test chemical was exposed to the skin of 99 human volunteers, and observed for dermal reactions (duration of exposure, observation period not specified).The eye shadow formulation didnot cause any dermal reactions to 99 volunteers tested.Hence,the eye shadow formulation containing 10% test chemical can be considered to be not sensitizing to human skin.

Based on the above summarized studies for target chemical ,it can be concluded that the test chemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance were observed in various studies. The results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.