Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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other: Non-GLP, available as unpublished report, near guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Test material information:
Composition 1
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 group
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 group
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 group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
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.

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.