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Description of key information

The test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "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:
experimental study
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 for the target chemical is summarized based on data from various test chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
WoE for the target CAS is summarized based on data from various test chemicals
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Not specified
Species:
other: 2/3. Humans; 4. Guinea pigs
Sex:
not specified
Route:
other: occlusive patches / 2
Vehicle:
other: Detergent
Remarks:
The detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
Route:
other: 2
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
3
Concentration / amount:
1 mg/mL
Day(s)/duration:
2 days
Adequacy of induction:
not specified
Route:
other: occlusive patches / 2
Vehicle:
other: Detergent
Remarks:
the detergent formulations used as vehicles contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, but without FWAs.
Route:
other: 2
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied.
No. of animals per dose:
2. 70 human subjects-a 0.5% aqueous solution of a detergent mixture containing 10% brightener
3. 103 female subjects
Challenge controls:
2. Challenge applications were made 2 weeks later-other details not available
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
70
Clinical observations:
No skin sensitization was observed
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
1 mg/mL
No. with + reactions:
0
Total no. in group:
103
Clinical observations:
No Clinical observation were seen in any of the subjects.
Remarks on result:
no indication of skin sensitisation
Remarks:
3

The material did not appear to cause irritation. None of the subjects was sensitized.

Interpretation of results:
not sensitising
Conclusions:
The test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".
Executive summary:

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

In the patch test in humans, the test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. No sensitization reaction was observed. The test chemical did not induce any allergic response on the human case subjects. Hence the test chemical is not likely to classify as a "skin sensitizer" .

Another skin sensitization study was also performed using the test chemical on human female subjects so as to identify the sensitizing potential of the test chemical. 103 white females were subjected to ten repeated patch tests (intervals not given) and challenge performed fourteen days after last patch test, totaling eleven applications. A one-half inch square of white blotting paper was impregnated with 1 mg/ml aqueous solution of test material and then was applied on clean back and covered with an "Elastopatch" plaster. The patch was allowed to remain in contact with the skin for forty-eight hours. Upon removal the test areas were observed for immediate reaction. There was no evidence of primary irritation upon removal of the 48 hour patch tests and no indication of sensitization potential on the challenge. Therefore, based on all the observations and results, it was concluded that the test chemical was not found to be sensitizing to the human subject, and is thus likely to be considered as 'Non-Sensitizing' as per CLP.

The skin sensitization study of the test chemical was carried out in guinea pigs to determine its sensitization efficacy. Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the skin of guinea pigs and hence it is not likely to classify as a "skin senstizer".

Based on the data available and applying the weight of evidence approach, the test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".

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

Respiratory sensitisation

Endpoint conclusion
Additional information:

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

In the patch test in humans, the test material (a 0.5% aqueous solution of a detergent mixture containing 10% brightener) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. No sensitization reaction was observed. The test chemical did not induce any allergic response on the human case subjects. Hence the test chemical is not likely to classify as a "skin sensitizer" .

Another skin sensitization study was also performed using the test chemical on human female subjects so as to identify the sensitizing potential of the test chemical. 103 white females were subjected to ten repeated patch tests (intervals not given) and challenge performed fourteen days after last patch test, totaling eleven applications. A one-half inch square of white blotting paper was impregnated with 1 mg/ml aqueous solution of test material and then was applied on clean back and covered with an "Elastopatch" plaster. The patch was allowed to remain in contact with the skin for forty-eight hours. Upon removal the test areas were observed for immediate reaction. There was no evidence of primary irritation upon removal of the 48 hour patch tests and no indication of sensitization potential on the challenge. Therefore, based on all the observations and results, it was concluded that the test chemical was not found to be sensitizing to the human subject, and is thus likely to be considered as 'Non-Sensitizing' as per CLP.

The skin sensitization study of the test chemical was carried out in guinea pigs to determine its sensitization efficacy. Since the guinea pigs did not elicit any sensitizing effect, the test chemical was considered to be not sensitizing to the skin of guinea pigs and hence it is not likely to classify as a "skin senstizer".

Based on the data available and applying the weight of evidence approach, the test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".

Justification for classification or non-classification

Based on the data available and applying the weight of evidence approach, the test chemical did not induce any allergic response on the human case subjects or animals. Hence the test chemical is not likely to classify as a "skin sensitizer".