Registration Dossier
Registration Dossier
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EC number: 266-411-4 | CAS number: 66576-71-4
Skin sensitisation
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:
- 1 999
- 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
- Reference substance name:
- Isopropyl methyl-2-butyrate
- IUPAC Name:
- Isopropyl methyl-2-butyrate
- 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)
Constituent 1
Constituent 2
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.
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