N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer-reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Safety Assessment of Isoparaffins as Used in Cosmetics

Author:

Wilbur Johnson, Wilma F. Bergfeld, Donald V. Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel Liebler, James G. Marks Jr., Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, F. Alan Andersen.

Year:

2012

Bibliographic source:

International Journal of Toxicology, vol. 31, suppl 3 : pp. 269S-295S, 2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

To determine acute dermal toxicity in Rabbits by using Isooctane.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,4-trimethylpentane

EC Number:

208-759-1

EC Name:

2,2,4-trimethylpentane

Cas Number:

540-84-1

Molecular formula:

C8H18

Details on test material:

- Name of test material (as cited in study report): 2,2,4-trimethylpentane (Isooctane)
- Molecular formula (if other than submission substance): C8H18
- Molecular weight (if other than submission substance): 114.23 g/mole
- Substance type: Organic
- Physical state: Colorless Liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2,2,4-trimethylpentane (Isooctane)
- Molecular formula (if other than submission substance): C8H18
- Molecular weight (if other than submission substance): 114.23 g/mole
- Substance type: Organic
- Physical state: Colorless Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Type of coverage:

other: Dermal

Vehicle:

not specified

Details on dermal exposure:

not specified

Duration of exposure:

not specified

Doses:

3160 mg/kg bw

No. of animals per sex per dose:

Groups of 4 Rabbits

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: No data
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: Yes
- Other examinations performed: Gross pathology was examined.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No moratlity were observed

Mortality:

No mortality was observed at 3160 mg/kg bw

Clinical signs:

not specified

Body weight:

not specified

Gross pathology:

Dark livers and mottled kidneys were observed at necropsy in treated rabbits.

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

LD50 was considered to be > 3160 mg/kg when rabbits were treated with Isooctane by dermal application to abraded abdominal skin.

Executive summary:

The acute dermal toxicity study was conducted by using Isooctane in Rabbit.

Groups of 4 New Zealand White Rabbits were taken for the dermal study. The given test material Isooctane was applied to abraded abdominal skin of rabbits at 3160 mg/kg. No mortality was observed at 3160 mg/kg bw. The dark livers and mottled kidneys were observed in Necropsy observation. Therefore, LD50 was considered to be > 3160 mg/kg when rabbits were treated with Isooctane by dermal application to abraded abdominal skin.