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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
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.

Test material

Constituent 1
Reference substance name:
Isopropyl methyl-2-butyrate
IUPAC Name:
Isopropyl methyl-2-butyrate
Constituent 2
Chemical structure
Reference substance name:
Isopropyl 2-methylbutyrate
EC Number:
266-411-4
EC Name:
Isopropyl 2-methylbutyrate
Cas Number:
66576-71-4
Molecular formula:
C8H16O2
IUPAC Name:
isopropyl 2-methylbutyrate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Isopropyl methyl-2-butyrate
- Substance type: organic
- Physical state: colourless liquid
- Analytical purity: 98.6%
- Lot/batch No.: Batch number: 9000322674
- Expiration date of the lot/batch: 25 March 2000
- Stability under test conditions: Stable under storage conditions; Stability of test article dilution: Unknown in PEG 400 and in a 1:1 (v/v) mixture of FCA/physiological saline; is excluded from the statement of compliance.
- Storage condition of test material: In the original container, in the refrigerator (range 2 - 8°C), away from direct sunlight (handling under dimmed light)

In vivo test system

Test animals

Species:
guinea pig

Results and discussion

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.

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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.