Registration Dossier

Diss Factsheets

Administrative data

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:
Weigth of evidence approach based on various test chemicals
Justification for type of information:
Weigth of evidence approach based on 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: Weight of evidence approach based on test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on test chemicals
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on test chemicals
Species:
other: 1, 2. guinea pigs;3. humans
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
42.8%
Adequacy of induction:
not specified
Route:
other: no data available
Vehicle:
not specified
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
42.8%
Adequacy of challenge:
not specified
No.:
#1
Route:
other: not mentioned
Vehicle:
not specified
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent
Adequacy of challenge:
not specified
No. of animals per dose:
1. no data available
2. 20
3. no data available
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
Group:
test chemical
No. with + reactions:
0
Clinical observations:
no signs of 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.

Buehler test was conducted to assess the dermal sensitization potential of the test chemical. The study was performed according to OECD Guideline 406 Guidelines. 20 Dunkin Hartley guinea pigs were used for the study.

In induction, the animals were induced dermally at concentration of 42.8 %. After induction, animals were challenged dermally with the same concentration under occlusive conditions (duration of exposure not mentioned). The guinea pigs were observed for signs of dermal irritation and sensitization (observation duration not mentioned).

No known skin reactions were observed at induction as well as at challenge exposure. Thus the test chemical was considered to be not sensitizing to the skin of Dunkin Hartley guinea pigs.

This is supported by the results of skin sensitization study performed in 20 guinea pigs to observed its sensitizing potential by guinea pig maximization test.

The test chemical failed to induce any signs of dermal sensitization through out the test duration. Hence, the test chemical can be considered to be not sensitizing to skin.

The above results are further supported by the results of Human repeat insult patch performed to assess the dermal sensitization potential of the test chemical. 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin and observed for dermal reactions(duration not mentioned). No evidence of dermal sensitization was observed when 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin. Hence, the test chemical can be considered to be not sensitizing to skin.

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.

Buehler test was conducted to assess the dermal sensitization potential of the test chemical. The study was performed according to OECD Guideline 406 Guidelines. 20 Dunkin Hartley guinea pigs were used for the study.

In induction, the animals were induced dermally at concentration of 42.8 %. After induction, animals were challenged dermally with the same concentration under occlusive conditions (duration of exposure not mentioned). The guinea pigs were observed for signs of dermal irritation and sensitization (observation duration not mentioned).

No known skin reactions were observed at induction as well as at challenge exposure. Thus the test chemical was considered to be not sensitizing to the skin of Dunkin Hartley guinea pigs.

This is supported by the results of skin sensitization study performed in 20 guinea pigs to observed its sensitizing potential by guinea pig maximization test.

The test chemical failed to induce any signs of dermal sensitization through out the test duration. Hence, the test chemical can be considered to be not sensitizing to skin.

The above results are further supported by the results of Human repeat insult patch performed to assess the dermal sensitization potential of the test chemical. 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin and observed for dermal reactions(duration not mentioned). No evidence of dermal sensitization was observed when 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin. Hence, the test chemical can be considered to be not sensitizing to skin.

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

The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not sensitizing to skin.

Hence, by applying the weight of evidence approach,the test chemical can be considered to be not sensitizing to skin.

Categories Display