Registration Dossier

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:
other: Basic data given , acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute Oral Toxicity of Mono- and Di-Alkyl Ring-Substituted Derivatives of Aniline
Author:
Jacobson KH
Year:
1972
Bibliographic source:
Toxicol. Appl. Pharmacol. 22, 153-154
Reference Type:
secondary source
Title:
Acute Oral Toxicity of Mono- and Di-Alkyl Ring-Substituted Derivatives of Aniline
Author:
Jacobson KH
Year:
1972
Bibliographic source:
cited in: Kornreich M and Montgomery CA: Toxicity and Carcinogenesis studies of 2,6-Xylidine; National Toxicology Program, Technical Report 278, NIH Publication No. NTP-82-94 (1990)
Reference Type:
publication
Title:
Acute Oral Toxicity of 2-Alkyl- and 2,6-Dialkylanilines Correlation with Lipophilicity
Author:
Durden JA
Year:
1973
Bibliographic source:
Journal of Medicinal Chemistry, 1973, Vol. 16, No. II, p. 1316

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Oral LD50 values of methylaniline derivatives were estimated in male rats.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6-dimethylaniline
- no further data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
840 mg/kg bw
95% CL:
640 - 1 120
Mortality:
no data
Clinical signs:
Severely intoxicated animals were lethargic before recovery or death, but no characteristic signs of toxicity were seen except cyanosis (bluish coloration of lower limbs and of mouth and nose), which was evident in only some of the severely intoxicated animals. Similarly, enlarged spleens and darkened organs and blood were seen in some, but not all, severely intoxicated animals. There was no apparent correlation between these ante and postmortem signs of methemoglobinemia with chemical structure or LD50 other than a suggestion of more frequent appearance of these signs in compounds with lower rather than higher LD50 values.
Body weight:
no data
Gross pathology:
Causes of death were not discovered.

Applicant's summary and conclusion