2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 Publication.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Range-Finding Toxicity Data

Author:

Henry et al.

Year:

1962

Bibliographic source:

American Industrial Hygiene Association Journal

Reference 2

Reference Type:

other: authoritative database

Title:

Acute Oral Toxicity of test chemical.

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

ChemIDplus, A TOXNET DATABASE, Lite Browse Advanced

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of test chemical in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-2-(Ethylhexyl)aniline

Cas Number:

10137-80-1

Molecular formula:

C14H23N

IUPAC Name:

N-2-(Ethylhexyl)aniline

Details on test material:

Name: N-2-(Ethylhexyl)aniline
InChI: 1S/C14H23N/c1-3-5-9-13(4-2)12-15-14-10-7-6-8-11-14/h6-8,10-11,13,15H,3-5,9,12H2,1-2H3
Smiles : c1(NC[C@@H](CCCC)CC)ccccc1
- Molecular formula :C14H23N
- Molecular weight:205.343 g/mole
- Substance type:organic

Test animals

Species:

rat

Strain:

other: Carworth-Wistar rats

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90-120 grams
- Fasting period before study: Fasting was not done.
- Diet (e.g. ad libitum): Rockland rat diet

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Vehicle was used

Details on oral exposure:

not specified

Doses:

2410 mg/kg (Range of 1880-3230 mg/kg bw)

No. of animals per sex per dose:

groups of 5

Control animals:

not specified

Details on study design:

not specified

Statistics:

Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality.

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2 410 mg/kg bw

Based on:

test mat.

95% CL:

1 880 - 3 230

Remarks on result:

other: 50% Mortality observed

Mortality:

50% Mortality observed at 2410 mg/kg bw

Clinical signs:

not specified

Body weight:

not specified

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The LD50 was considered to be 2410 mg/kg bw, wih 95% confidence limit of 1880-3230 mg/kg bw, when groups of 5 Carworth-Wistar male rats were treated with test chemical via oral route.

Executive summary:

Acute oral toxicity study was conducted using test chemical in groups of 5 Carworth-Wistar male rats at the concentration range of 1880-3230 mg/kg bw. The test chemical was dissolved in suitable vehicle and administered via oral route. The dosages are arranged in a logarithmic series differing by a factor of two. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality. 50% Mortality observed at 2410 mg/kg bw. Therefore, LD50 was considered to be 2410 mg/kg bw, wih 95% confidence limit of 1880-3230 mg/kg bw, when Carworth-Wistar male rats were treated with test chemical via oral route.