N,N-dimethyl-p-toluidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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 authoritative database.

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Hazardous Substances Data Bank

Author:

U.S. National Library of Medicine

Year:

2015

Bibliographic source:

HSDB

Reference 2

Reference Type:

review article or handbook

Title:

Summary of Data for Chemical Selection

Author:

NTP

Year:

1999

Bibliographic source:

NTP

Reference 3

Reference Type:

other: secondary source

Title:

Test Substance - Acute Toxicity

Author:

United States Environmental Protection Agency

Year:

2019

Bibliographic source:

HPVIS

Reference 4

Reference Type:

other: secondary source

Title:

Results of an Acute Oral Toxicity Study in Rats

Author:

U.S. Environmental Protection Agency

Year:

2009

Bibliographic source:

U.S. Environmental Protection Agency

Reference 5

Reference Type:

other: secondary database

Title:

Human health tier II assessment.

Author:

NICNAS

Year:

2019

Bibliographic source:

NICNAS

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity study of the given test chemical was performed in rat.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyl-p-toluidine

EC Number:

202-805-4

EC Name:

N,N-dimethyl-p-toluidine

Cas Number:

99-97-8

Molecular formula:

C9H13N

IUPAC Name:

N,N,4-trimethylaniline

Test material form:

liquid

Details on test material:

- Name of test material: Benzenamine, N,N,N-trimethyl-
- Common Name: N,N-Dimethyl-p-toluidine
- Molecular formula: C9H13N
- Molecular weight: 135.209 g/mol
- Smiles notation: c1(N(C)C)ccc(C)cc1
- InChl: 1S/C9H13N/c1-8-4-6-9(7-5-8)10(2)3/h4-7H,1-3H3
- Substance type: Organic
- Physical state: liquid
- Purity: Greater than 99%.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: fasting was done

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not specified

Doses:

1250, 1800 and 2500 mg/kg bw

No. of animals per sex per dose:

groups of five male and five female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: The rats were observed for 14 days after test substance administration.
- Other examinations performed: Animals were observed for mortality and clinical signs.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 300 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 950 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 650 mg/kg bw

Based on:

test mat.

Mortality:

Mortality occurred on days 2 to 3 in 1/5, 5/5, and 5/5 male rats and in 1/5, 0/5, and 5/5 female rats dosed at 1250, 1800, and 2500 mg/kg, respectively.

Clinical signs:

other: other: other: Decreased activity (slight to moderate) was observed up to test day 9 in 7 rats dosed at 1250 mg/kg, in 6 rats dosed at 1800 mg/kg, and in 8 rats dosed at 2500 mg/kg. Decreased activity (extreme) was observed up to test day 2 in 2 rats dosed

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Acute oral toxicity dose (LD50) value was considered to be 1300 mg/kg in male rats, 1950 mg/kg in female rats and 1650 mg/kg in male and female rats combined.

Executive summary:

Acute oral toxicity study was conducted for the test chemical as per OECD 401. The test chemical was dosed via gavage to groups of five male and five female Sprague-Dawley rats at the test concentration of 1250, 1800 and 2500 mg/kg bw. The rats were observed for 14 days after test chemical administration for mortality and clinical signs. Mortality occurred on days 2 to 3 in 1/5, 5/5, and 5/5 male rats and in 1/5, 0/5, and 5/5 female rats dosed at 1250, 1800, and 2500 mg/kg, respectively. Decreased activity (slight to moderate) was observed up to test day 9 in 7 rats dosed at 1250 mg/kg, in 6 rats dosed at 1800 mg/kg, and in 8 rats dosed at 2500 mg/kg. Decreased activity (extreme) was observed up to test day 2 in 2 rats dosed at 1250 mg/kg and in 3 rats dosed at 2500 mg/kg. Hunched posture was observed on test days 5-8 in one rat dosed at 1800 mg/kg. Salivation (slight to moderate) was observed the day after dosing in one rat dosed at 2500 mg/kg.Under the conditions of the study, the acute oral toxicity dose (LD50) value was considered to be 1300 mg/kg in male rats, 1950 mg/kg in female rats and 1650 mg/kg in male and female rats combined.