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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.