2-methyl-3-butenenitrile

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

No data

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: The purity of the test substance tested is unknown. 2-methyl-3-butenenitrile with impurities (2M2BN and cyane)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

To test the sensitization potential of 2-methyl-3-butenenitrile, a series of four sacral intradermal injections was given to ten male albino guinea pigs, one each week over a three-week period, which consisted of 0.1 ml of a 1% solution (vol/vol) of test substance in dimethyl phthatale. Following a two-week rest period, the test animals were challenged for sensitization by applying, and lightly rubbing in, 1 drop (= 0.05 ml) each of material as received and a 10% solution (vol/vol) of test substance in acetone on the shaved intact shoulder skin. A group of 10 previously unexposed guinea pigs received similar applications at the time of challenge to provide a direct comparison of the challenge reactions on skin of similar age.

GLP compliance:

not specified

Remarks:

But the study was performed before the GLP statment.

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-3-butenenitrile

EC Number:

240-596-1

EC Name:

2-methyl-3-butenenitrile

Cas Number:

16529-56-9

Molecular formula:

C5H7N

IUPAC Name:

2-methylbut-3-enenitrile

Details on test material:

- Name of test material (as cited in study report): 2-methyl-3-butenenitrile
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): Trans-2-methyl-2-butenenitrile + cyane (cyclohexane)
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: albino

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 580 g
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
no data


IN-LIFE DATES: no data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: acetone

Induction 2

Concentration / amount:

100 % and 10 % in solution of acetone

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

other: acetone

Challenge 2

Concentration / amount:

100 % and 10 % in solution of acetone

No. of animals per dose:

10

Details on study design:

RANGE FINDING TESTS: no data


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: four
- Exposure period: three weeks
- Test groups: ten male albino guinea pigs
- Control group: ten male albino guinea pigs
- Site: intradermal, no data
- Frequency of applications: weekly
- Duration: three weeks
- Concentrations: 0.1 ml of a 1% solution (vol/vol) of test substance


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: no data
- Exposure period: no data
- Test groups: ten albino male guinea pigs
- Control group: ten albino male guinea pigs
- Site: shaved intact shoulder skin
- Concentrations: 1 drop (= 0.05 ml) each of material as received and a 10% solution (vol/vol) of test substance in acetone
- Evaluation (hr after challenge): 24 and 48 hours


OTHER: no data

Challenge controls:

A group of 10 previously unexposed guinea pigs received similar applications at the time of challenge to provide a direct comparison of the challenge reactions on skin of similar age.

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Statistics:

No data

Results and discussion

Positive control results:

No data

Any other information on results incl. tables

7.4.1: Sensitization test results

	Test Areas		Control Areas
Concentration in acetone	100%	10%	100%	10%
24 hours	10 neg.	10 neg.	10 neg.	10 neg.
48 hours	10 neg.	10 neg.	10 neg.	10 neg.
Sensitization Response Ratio	0/10	0/10	0/10	0/10

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the test conditions of this study, 2-methyl-3-butenenitrile (impurities: 2M2BN and cynae) is not sensitizing.

Executive summary:

In a skin sensitisation study, ten male albino guinea pigs were exposed to 2-methyl-3-butenenitrile (impurities: 2M2BN and cyane) by dermal way. No guideline was followed and no GLP compliance.

A series of four sacral intradermal injections was given to ten male albino guinea pigs, one each week over a three-week period, which consisted of 0.1 ml of a 1% solution (vol/vol) of test substance in dimethyl phthatale. Following a two-week rest period, the test animals were challenged for sensitization by applying, and lightly rubbing in, 1 drop (= 0.05 ml) each of material as received and a 10% solution (vol/vol) of test substance in acetone on the shaved intact shoulder skin. A group of 10 previously unexposed guinea pigs received similar applications at the time of challenge to provide a direct comparison of the challenge reactions on skin of similar age.

No sensitization was observed at challenge. No unusual dermatitis hazard is expected from use of 2 -methyl-3 -butenenitrile.