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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across: GLP guideline study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
The experiments were aimed at comparing exposure of dogs via the oral route and inhalation to analyze the magnitude of error involved with route-to-route extrapolation.
GLP compliance:
yes
Test type:
other: Exposing of dogs to a sub-lethal concentration.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
dog
Strain:
other: Beagle: Hsd Cpb: DOBE
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
head only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gas chromatography
Duration of exposure:
4 h
Remarks on duration:
A first group was exposed for 4 h continously whereas a second group was exposed 4 periods of 1 h, with a 10-minute break Twelve days after inhalation, the dogs from the first group were exposed to aniline by oral route (gavage).
Concentrations:
Group I: 174 mg/m³; Group II: 155 mg/m³.
No. of animals per sex per dose:
4 dogs per group, not specified per sex.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Induction of 5% MetHb formation.
Effect level:
165 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Analytical results showed that Group I was exposed to 174 ± 8.3 mg/m³ and Group II to 155 ± 8.1 mg/m³, delivered doses are 15 and 13 mg/kg bw, respectively.

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Through inhalation aniline appeared to be signficantly less toxic than by oral route. Criteria used for interpretation of results: expert judgment