Isobutyronitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was conducted pre-GLP and pre-guidelines, so the report is lacking in detail. However, it was conducted at a highly reputable laboratory and was done to the state of the art at that time.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

This study was conducted as part of the acute dermal toxicity test presented in section 7.2.3. Since the exposure period (24 hours) and the covering (occlusive) used in the dermal toxicity test was more stringent than that used in a traditional OECD 404 (4 hour exposure and semi-occlusive covering), this data can be considered to be a worst-case finding.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyronitrile

EC Number:

201-147-5

EC Name:

Isobutyronitrile

Cas Number:

78-82-0

Molecular formula:

C4H7N

IUPAC Name:

2-methylpropanenitrile

Constituent 2

Reference substance name:

iso-Butyronitrile

IUPAC Name:

iso-Butyronitrile

Constituent 3

Reference substance name:

210-147-5

IUPAC Name:

210-147-5

Test animals

Species:

guinea pig

Strain:

not specified

Details on test animals or test system and environmental conditions:

None provided

Test system

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

This test was run in triplicate with the following concentrations:
1) Undiluted at 5 and 10 cc/kg
2) 20% in 90/10 acetone/corn oil (5-20 cc/kg)
3) 5% in 90/10 acetone/corn oil (5-20 cc/kg)

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Details on study design:

Skin irritation was evaluated as part of an acute dermal toxicity test.

Results and discussion

In vivo

Results

Irritation parameter:

other:

Time point:

other: 24 hours

Score:

> 0 - < 0

Remarks on result:

other: findings were not scored, but TCC requires a score value, so "0" was used

Irritant / corrosive response data:

The test article was called out as a moderate skin irritant that is absorbed through the skin.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test article was called out as a moderate skin irritant that is absorbed through the skin.

Executive summary:

Skin irritation testing was done as part of a previously cited acute dermal toxicity test. As such, the test subjects were exposed to the test article for 24 hours under occlusive conditions rather than the traditional 4 hours under semi-occlusive conditions. That makes these results a "worst case". The test article was called out as a moderate skin irritant that is absorbed through the skin. No numerical grading was performed.