Registration Dossier

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other: Non-GLP, available as unpublished report, near guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-methyl-2-butene
- Physical state: Strong smelling, colourless liquid with a specific gravity of 0.66
- Stability under test conditions: stable for duration of experiment, expiry date 1 January 1981
- Storage condition of test material: in fridge


In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.