Registration Dossier

Administrative data

Description of key information

Skin sensitisation

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test 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 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on guinea pigs and humans to determine the potential of skin sensitization caused by the chemical.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified
Species:
other: 2.guinea pig 3. human
Strain:
other: 2. Not specified 3. Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1 ml of 0.1 % aqueous solution
Day(s)/duration:
5 days
Adequacy of induction:
other: WoE-2
Route:
other: No data available
Adequacy of induction:
other: WoE-3
No.:
#1
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1 ml of 0.1 % aqueous solution
Day(s)/duration:
Not specified
Adequacy of challenge:
other: WoE-2
Route:
other: No data available
Adequacy of challenge:
other: WoE-3
No. of animals per dose:
Not specified
Details on study design:
2. A. INDUCTION EXPOSURE
- No. of exposures: 3 times/ day for 5 successive days
- Exposure period: not speccified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Frequency of applications: 3 times a day
- Duration: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: not specified
- Exposure period: not specified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution
- Evaluation (hr after challenge): not specified

OTHER: challenge treatment was provided 4 weeks after the induction

3. Not specified
Challenge controls:
not specified
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
Dose level:
0.1 ml of 0.1 % aqueous solution
Clinical observations:
No skin allergic reactions were observed.
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Group:
test chemical
Dose level:
No data available
No. with + reactions:
0
Clinical observations:
A 16-years period of use in cosmetics not a single case of allergy in humans.
Remarks on result:
no indication of skin sensitisation
Remarks:
3
Interpretation of results:
other: Not sensitizing
Conclusions:
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Executive summary:

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

The skin sensitization potential of test chemical was evaluated using Guinea pig maximization test. The test chemical in induction treatment was subjected onto the skin of guinea pig by intracutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test chemical was considered to be not skin sensitizing.

 

The above study was supported with another skin sensitization study of test chemical assessed in a 16 year period study. In this study, the cosmetic use of test chemical did not cause a single case of contact allergy in humans within the 16 year period. Hence the test chemical was considered to be not sensitizing to the human skin.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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

Skin sensitization

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

The skin sensitization potential of test chemical was evaluated using Guinea pig maximization test. The test chemical in induction treatment was subjected onto the skin of guinea pig by intracutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test chemical was considered to be not skin sensitizing.

 

The above study was supported with another skin sensitization study of test chemical assessed in a 16 year period study. In this study, the cosmetic use of test chemical did not cause a single case of contact allergy in humans within the 16 year period. Hence the test chemical was considered to be not sensitizing to the human skin.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.