Registration Dossier
Registration Dossier
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EC number: 421-720-5 | CAS number: 18085-02-4 3,4-DIACETOXY-1-BUTENE
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data migrated from NONS with permission to refer granted by ECHA.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC (Maximisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data provided by ECHA and permission to refer granted. No justifications available for why the LLNA was not used. We can only assume the test was conducted prior to the implementation of LLNA test guideline
Test material
- Reference substance name:
- 1,2-diacetoxybut-3-ene
- EC Number:
- 421-720-5
- EC Name:
- 1,2-diacetoxybut-3-ene
- Cas Number:
- 18085-02-4
- Molecular formula:
- C8H12O4
- IUPAC Name:
- 1-(acetyloxy)but-3-en-2-yl acetate
- Test material form:
- liquid
- Details on test material:
- No information on test material available. Endpoint study information provided by ECHA from migrated NONS data and specific information not included.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 5% in water
- Concentration / amount:
- Induction: Intradermal 5% in water and topical 100% (unchanged).
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
Challenge
- Route:
- other: Epicutaneous (no futher details)
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 in the test group and 10 in the negative control.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None specified
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Maximum concentration not causing irritating effects in the preliminary test: 100%
Signs of irritation during induction: irritation was observed following application of sodium lauryl sulfate and prevented scoring of irritation due to the test substance alone. In the preliminary study no irritation was observed following intradermal injection (5%) or topical application (100%).
No evidence of sensitisation at each challenge was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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