Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Contribution à l'étude toxicologique de l'alcool n-heptylique primaire,
Author:
R. Truhaut
Year:
1974
Bibliographic source:
Archives des maladies professionelles, de médecine du travail. T35, 4-5, Avril-Mai, (p 501-509)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity >97%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
10 males (250 g) and 10 females (200g) wistar rats

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
7.4 mg/m3
No. of animals per sex per dose:
10 males and 10 females rats
Control animals:
no
Details on study design:
single exposure of the whole body during 4 hours at the maximum saturated concentration. The animals were submitted to a two week observation period after exposure.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 7.4 mg/m³ air
Exp. duration:
4 h
Remarks on result:
other: maximum saturated vapor concentration
Mortality:
none
Clinical signs:
none
Body weight:
no changes
Gross pathology:
no changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other:
Conclusions:
N-heptanol is not toxic by inhalation
Executive summary:

The test item, n-heptanol-1 was exposed by inhalatation to 10 males and 10 females rats at the maximum saturated concentration via asingle whole body inhlation exposure during 4 hours. Animals were submitted to a 2 week observation period.

No mortality was recorded in any animal. No signs of narcosis were observed nor abnormal behaviour. The histopathological examination of the sample organs (brain, lung, heart, liver, pancreas, bladder, kidneys, ovaries and testes) has revealed no treatement related changes. At the maximum vapour saturated concentration, no mortality was recorded after a single exposure during 4 hours. The LC0 was estimated at 7.4 mg/m3.