Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The substance is not classified as a skin sensitiser. This was predicted in the read-across justification document and is supported by the EMV result.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Data waving
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 June to 19 July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was available and a further study is not justified on the grounds of animal welfare.
Species:
guinea pig
Positive control results:
After an induction phase of 5% 2-mercaptobenzothiazole, a challenge phase of 10% 2-mercaptothiobenzothiazole in mineral oil elicited a 90% (9/10) response in animals at the 24 hour reading and 100% (10/10) response in animals at the 48 hour reading. Note, these results were obtained in a separate study conducted and reported separately. They are reported as an appendix to the main report.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Group:
positive control
Dose level:
25%
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the above mentioned findings in an adjuvant sensitization test in guinea pigs, Isopropyl methyl-2-butyrate is considered not to be a skin sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on the above mentioned findings in an adjuvant sensitization test in guinea pigs, Isopropyl methyl-2-butyrate is considered not to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No study available for respiratory sensitisation. IMB will not be classified as a skin sensitiser as in an adjuvant sensitization test in guinea pigs, Isopropyl methyl-2-butyrate is considered not to be a skin sensitizer.