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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 and was estimated to be not sensitizing to skin.

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
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
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on various test chemicals
Species:
other: 1. guinea pigs; 2. humans
Strain:
not specified
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1ml of 1% aqueous solution
Day(s)/duration:
once a week for 4 weeks
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% aqueous solution of the test chemical
Day(s)/duration:
10 minutes
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
0.05ml of 5% of the test chemical in propylene glycol
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% aqueous solution
Day(s)/duration:
10 minutes
Adequacy of challenge:
not specified
No. of animals per dose:
1. ten guinea pigs
2. 49 atopic and 56 nonatopic patients
Details on study design:
The data is based on weight of evidence approach based on various test chemicals
Positive control substance(s):
not specified
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
No. with + reactions:
0
Clinical observations:
no dermal reactions 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 and was estimated to be not sensitizing to skin.
Executive summary:

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

Guinea pig maximisation test was performed to assess the dermal sensitization potential of the test chemical. Group of ten guinea pigs were used for the study.

For induction, 0.1ml of 1% aqueous solution of the test chemical was given as a sacral intradermal injection, once a week for 4 weeks to group of ten guinea pigs. After a rest period of 2 weeks, animals were challenged with 0.05ml of 5% of the test chemical in propylene glycol.

The test chemical failed to induce sensitization reactions in the treated guinea pigs. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs. 

The above experimental result was supported by the results of a Patch test conducted to determine the degree of contact dermatitis caused when humans volunteers were exposed to the test chemical.49 atopic and 56 nonatopic patients were applied 10% aqueous solution of the test chemical under occlusive conditions and observed for 20 minutes.

No immediate (non immunological contact urticaria) reactions were observed. Hence, the test chemical was 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 and was estimated to be not sensitizing to skin.

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

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

Guinea pig maximisation test was performed to assess the dermal sensitization potential of the test chemical. Group of ten guinea pigs were used for the study.

For induction, 0.1ml of 1% aqueous solution of the test chemical was given as a sacral intradermal injection, once a week for 4 weeks to group of ten guinea pigs. After a rest period of 2 weeks, animals were challenged with 0.05ml of 5% of the test chemical in propylene glycol.

The test chemical failed to induce sensitization reactions in the treated guinea pigs. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs. 

The above experimental result was supported by the results of a Patch test conducted to determine the degree of contact dermatitis caused when humans volunteers were exposed to the test chemical.49 atopic and 56 nonatopic patients were applied 10% aqueous solution of the test chemical under occlusive conditions and observed for 20 minutes.

No immediate (non immunological contact urticaria) reactions were observed. Hence, the test chemical was 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 and was estimated to be not sensitizing to skin.

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.