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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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:
Currently no LLNA Study is available for assessment.
Species:
other: 1. guinea pigs; 2. humans
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
0.1 ml
Day(s)/duration:
three times weekly (Monday, Wednesday Friday) for three consecutive weeks
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% in water on Mondays, Wednesdays and Fridays, total 10 applications
Day(s)/duration:
24 hours- Mondays, Wednesdays and Fridays, total 10 applications
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
10.0%, 5.0%, and 2.5%.
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% in water on Mondays, Wednesdays and Fridays, total 10 applications
Day(s)/duration:
24 hours- Mondays, Wednesdays and Fridays, total 10 applications
Adequacy of challenge:
not specified
No. of animals per dose:
1. 10 guinea pigs
2. 50 human volunteers
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
No. with + reactions:
0
Clinical observations:
no signs of sensitization were observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
Executive summary:

Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, guinea pigs for the test chemicals.

Skin sensitization study for test chemical was conducted in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing.

 For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. After a rest period of two weeks. In challenge phase the right flank of each guinea pig was shaved and exposed to three different concentration10.0%, 5.0%, and 2.5%.Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.

 

No erythema/edema was observed after application of test material .The test result was observed to be negative for the test substance. Therefore the test chemical was considered to be not sensitizing to the skin of guinea pig using modified Buehler and Klecak method for open Epicutaneous testing .

This is supported by the results of a human repeated insult patch test conducted on 50 subjects to assess the contact sensitization caused by the chemical under occlusive condition.

Induction was carried out at a dose of 5% in water on Mondays, Wednesdays and Fridays, total 10 applications were made. After 24 hours patches were removed and skin sits were scored for primary irritation.   After a rest period of 10-14 days, a challenge patch was applied (to the same site, an adjacent site or both). After 24 hours the patches were removed and the sites were examined for reactions immediately and 24 and 48 hours later.   Since there was no evidence of any contact sensitization, the chemical was considered to be notsensitizingon skin of human subjects.

Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.

Endpoint:
skin sensitisation: in vitro
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
The study is ongoing and this information will be submitted later based on ECHA communication/decision number CCH-D-2114554511-55-01/F.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, guinea pigs for the test chemicals.

Skin sensitization study for test chemical was conducted in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing.

For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. After a rest period of two weeks. In challenge phase the right flank of each guinea pig was shaved and exposed to three different concentration 10.0%, 5.0%, and 2.5%.Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.

 

No erythema/edema was observed after application of test material .The test result was observed to be negative for the test substance. Therefore the test chemical was considered to be not sensitizing to the skin of guinea pig using modified Buehler and Klecak method for open Epicutaneous testing .

This is supported by the results of a human repeated insult patch test conducted on 50 subjects to assess the contact sensitization caused by the chemical under occlusive condition.

Induction was carried out at a dose of 5% in water on Mondays, Wednesdays and Fridays, total 10 applications were made. After 24 hours patches were removed and skin sits were scored for primary irritation.   After a rest period of 10-14 days, a challenge patch was applied (to the same site, an adjacent site or both). After 24 hours the patches were removed and the sites were examined for reactions immediately and 24 and 48 hours later.   Since there was no evidence of any contact sensitization, the chemical was considered to be notsensitizingon skin of human subjects.

Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.

However the final classification will be given based on the results from OECD 442C &D study, as it was ongoing currently.