4-bromo-2,2-diphenylbutanenitrile

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:

guideline study with acceptable restrictions

Remarks:

Non GLP and provided limited information on materials and methods. However, the report stated that the methods in the study followed OECD guideline 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

limited information on test item and test system

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report had not been audited by the QA Unit. No formal claim of GLP complicance was made for the study.

Test material

Test material information

Constituent 1

Reference substance name:

4-bromo-2,2-diphenylbutanenitrile

EC Number:

254-337-5

EC Name:

4-bromo-2,2-diphenylbutanenitrile

Cas Number:

39186-58-8

Molecular formula:

C16H14BrN

IUPAC Name:

4-bromo-2,2-diphenylbutanenitrile

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): JNJ-1597622-AAA (T000625)
- Physical state: solid (powder)
- Appearance: White powder

Specific details on test material used for the study:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: No data


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data


SCORING SYSTEM: Classification categories for irritant were from Draize J H (1995) "Dermal Toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Drug Officials of the US, Austin, Texas p47. Classification was based on the Primary Irritation Index (calculated from erythema/eschar formation and oedema formation scores) from the 24 and 72 hour time points.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Based on 24 and 72 hour time points

Score:

ca. 0

Max. score:

6

Remarks on result:

other: All three animals scored a 0 for erythema/eschar formation and oedema formation at all time points evaluated.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No evidence of skin irritation (erythema/eschar formation and oedema formation) was noted at any of the time points evaluated (1, 24, 48 and 72 hours).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was determined to be a non-irritant, based on a primary index score of 0.0. Based on the criteria of the CLP regulation (EC) 1272/2008, the test item did not meet the criteria for classification.