Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
- very limited documentation
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptane
EC Number:
205-563-8
EC Name:
Heptane
Cas Number:
142-82-5
Molecular formula:
C7H16
IUPAC Name:
heptane
Details on test material:
- Name of test material (as cited in study report): n-Heptane
- Analytical purity: 100% pure commercial product

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
29.29 mg/L nominal
17937.5 ± 5665.92 ppm (mean analytical concentration and SD) = 73.5 mg/L ± 2.32 (re-calculated from ppm value given in study report)
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: not specified, but at least 4 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 29.29 mg/L air (nominal)
Exp. duration:
4 h
Remarks on result:
other: only one concentration tested
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 73.5 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: only one concentration tested
Sex:
male/female
Dose descriptor:
LC0
Effect level:
>= 29.29 mg/L air (nominal)
Exp. duration:
4 h
Remarks on result:
other: only one concentration tested
Mortality:
No mortality occurred during the course of the study.
Clinical signs:
other: No clinical signs observed throughout the study.
Body weight:
Slight reduction of mean male body weights on day 2 post exposure, but males recovered by day 4.
Female weight changes were minimal.
All animals appeared normal throughout the study.
Gross pathology:
All animals appeared normal at terminal necropsy with the exception of one female with enlarged mandibular lymph nodes on the right side

Any other information on results incl. tables

Normal-Heptane has a low order of toxicity by the inhalation route of exposure.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study design Normal-Heptane has a low order of toxicity by the inhalation route of exposure and needs not to be classified.
Executive summary:

Based on the study design Normal-Heptane has a low order of toxicity by the inhalation route of exposure and needs not to be classified.