Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Referenceopen allclose all

Reference Type:
other: authoritative database
Title:
Hazardous Substances Data Bank
Author:
U.S. National Library of Medicine
Year:
2015
Bibliographic source:
HSDB
Reference Type:
review article or handbook
Title:
Summary of Data for Chemical Selection
Author:
NTP
Year:
1999
Bibliographic source:
NTP
Reference Type:
other: secondary source
Title:
Test Substance - Acute Toxicity
Author:
United States Environmental Protection Agency
Year:
2019
Bibliographic source:
HPVIS
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 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

Constituent 1
Chemical structure
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 levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 300 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 950 mg/kg bw
Based on:
test mat.
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: 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
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.