Registration Dossier
Registration Dossier
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EC number: 204-070-5 | CAS number: 115-19-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- A collection of guinea pig sensitization test results - grouped by chemical class
- Author:
- Rao KS et al.
- Year:
- 1 981
- Bibliographic source:
- Drug. Chem. Toxicol. 4, 331-351
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report - 2-Methylbut-3-yn-ol
- Author:
- Rao KS et al.
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: in compliance with Maguire H. C.: J. Soc. Cosmet. Chem. 24, 151, 1973
- GLP compliance:
- not specified
- Type of study:
- other: modified Split adjuvant test
Test material
- Reference substance name:
- 2-methylbut-3-yn-2-ol
- EC Number:
- 204-070-5
- EC Name:
- 2-methylbut-3-yn-2-ol
- Cas Number:
- 115-19-5
- Molecular formula:
- C5H8O
- IUPAC Name:
- 2-methylbut-3-yn-2-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: ca. 300 g
- Diet (e.g. ad libitum): ad libitum, urina guinea pig chow supplemented with green vegetables
- Water (e.g. ad libitum): ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- no data given
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- no data given
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: yes
- test substance was applied to clipped flank; if irritation was observed dilutions were prepared
- The highest concentration which did not cause primary irritation was used for the guinea pig sensitization test
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Test groups: 10 animals
- Site: clipped and depilated back of animals
- Frequency of applications: 4 times in 10 days
- Concentrations: no data
- Additions: at the time of the third application, 0 .2 ml of Freund's Adjuvant was injected intradermally at one point adjacent to the insult site
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) after induction: 2 weeks
- Control: solvent control on other flank of the same animal; 10 animal for positive control
- Site: clipped flank
- Concentration: 100%
- Evaluation (hr after challenge): 24, 48 h
Evaluation:
- A moderate erythema and/or edema in two or more guinea pigs was considered sufficient to classify the test material as a potential human skin sensitizer . - Challenge controls:
- - solvent
- Positive control substance(s):
- yes
- Remarks:
- Epoxy Resin
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:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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