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Description of key information

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on 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: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals. The study 2,3 are referrred as Study 1,2 .
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on various test chemicals
Justification for non-LLNA method:
not specified
Species:
other: humans
Strain:
not specified
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
2% in white petrolatum
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: white petrolatum
Concentration / amount:
2% in white petrolatum
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Adequacy of challenge:
not specified
No. of animals per dose:
1. 30
2. 16
Details on study design:
The data is based on weight of evidence approach based on various test chemicals
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
No. with + reactions:
0
Clinical observations:
no signs of dermal sensitization observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Executive summary:

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

The test was conducted on a group of 32 patients with presumable allergic contact dermatitis and all with a positive patch teat reaction to p-aminoazobenzene (0.25% pet). The group consisted of 20 women (mean age 39.9 years) and men (mean age 46.6 years). 11 patients had previously also shown sensitization to PPD (Para-phenyldiamine). 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.

A patch with test chemical was placed in small squares (about 1.0 cm2) and wetted with 1 drop of tap water, water was used to imitate the circumstances (wet hands or sweating of hands). By this procedure a slight but visible yellow stain on the skin was found at the test site after 2 days of application, indicating liberation of the dyes.

The test chemical did not elicit a positive patch test reaction in any one of the 32 patients’ positive to p-aminoazobenzene nor in the 30 control subjects. Hence, the test chemical was considered to be not sensitizing.

This is supported by the results of another patch test performed to determine the skin sensitization potential of the test chemical. The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. 16 patients were tested with the dye.

Only one positive reaction was observed of 16 patients tested.

Hence, the test chemical can be considered as non- sensitizer in humans.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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

The skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

The test was conducted on a group of 32 patients with presumable allergic contact dermatitis and all with a positive patch teat reaction to p-aminoazobenzene (0.25% pet). The group consisted of 20 women (mean age 39.9 years) and men (mean age 46.6 years). 11 patients had previously also shown sensitization to PPD (Para-phenyldiamine). 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.

A patch with test chemical [2% in white petrolatum] was placed in small squares (about 1.0 cm2) and wetted with 1 drop of tap water, water was used to imitate the circumstances (wet hands or sweating of hands). By this procedure a slight but visible yellow stain on the skin was found at the test site after 2 days of application, indicating liberation of the dyes.

The test chemical did not elicit a positive patch test reaction in any one of the 32 patients’ positive to p-aminoazobenzene nor in the 30 control subjects. Hence, the test chemical was considered to be not sensitizing.This is supported by the results of another patch test performed to determine the skin sensitization potential of the test chemical.

Patch test was performed to determine the skin sensitization potential of the test chemical. The dye[1% in petrolatum] was applied in Finn Chambers to the skin of 16 human volunteers. The reactions were read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. 16 patients were tested with the dye.

Only one positive reaction was observed of 16 patients tested.

Hence, the test chemical can be considered as non- sensitizer in humans.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.