Registration Dossier
Registration Dossier
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EC number: 208-156-3 | CAS number: 513-35-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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- other: Non-GLP, available as unpublished report, near guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Shell Toxicology Unit 'P' strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory Breeding Unit
- Age when received: 8-12 weeks
- Weight at study initiation: males 439 - 700 g and females 337- 596 g
- Housing:Five animals per cage in hanging-stainless steel cages with all mesh floors and tops and half mesh fronts (43 x 36 x 36 cm)
- Diet: SG1 with vitamin C supplement (Grain Harvesters Ltd) ad libitum
- Water:Flitered public water ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS: not reported
-
IN-LIFE DATES: From: 7 May 1980 To: 18 July 1980 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.01% w/v; topical induction 50% w/v, topical challenge 25% w/v
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.01% w/v; topical induction 50% w/v, topical challenge 25% w/v
- No. of animals per dose:
- 10 males and 10 females test group, 5 males and 5 females control group.
- Details on study design:
- RANGE FINDING TESTS:
2 male and 2 female guinea pigs/group tested with intradermal injection at 0.05, 0.1, 0.5 and 1.0 % w/v 2-methyl-2-butene in corn oil. 2 male and 2 female guinea pigs/group treated with a topical application of 100%, 50% or 25% 2-methyl-2-butene in corn oil.
MAIN STUDY
A. INDUCTION EXPOSURE
Test animals:
2 x 0.1mL injections of Freund's complete adjuvant (FCA)
2 x 0.1 mL injections of TS in corn oil
2 x 0.1 mL injections of TS in 50:50 FCA/corn oil
Control animals:
2 x 0.1mL injections of Freund's complete adjuvant (FCA)
2 x 0.1 mL injections of corn oil
2 x 0.1 mL injections of 50:50 FCA/corn oil
B. CHALLENGE EXPOSURE
Topical challenge of test and control animals was carried out two weeks after the topical induction with 0.15 mL of a 25% w/v preparation of 2-methyl-2-butene in corn oil. After 24 hours the patch was removed and the site was examined for response, immediately, 24 hours and 48 hours after removal. The responses were scored using a standard four point scale. - Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other:
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 2-methyl-2-butene is not a sensitiser to guinea pig skin.
- Executive summary:
2-methyl-2-butene is not a sensitiser to guinea pig skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Studies in Animals
The skin sensitization potential of 2 -methyl-2 -butene (2M2B) was assessed using the guinea-pig maximization method of Magnusson and Kligman (1969). None of the animals showed any positive reactions 24 or 48 hours after the removal of the challenge patch, it can be concluded that 2M2B is not a skin sensitizer in guinea pigs (SRC, 1980).
Human data
No data available
Migrated from Short description of key information:
2-methylbut-2-ene (2M2B) is not a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Available information indicates that this substance does not induce or elicit skin sensitisation
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Respiratory Tract
No specific respiratory sensitisation tests have been conducted in animals. There is no evidence of respiratory sensitisation from existing animal study data.
Studies in Humans
No data available
Migrated from Short description of key information:
There are no specific studies available, but also no evidence of respiratory sensitisation from existing data.
Justification for classification or non-classification
No classification of 2 -methylbut-2 -ene for sensitisation is warranted under CLP.
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