Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 heptylique
Author:
R. Truhaut
Year:
1974
Bibliographic source:
Archives des maladies professionelles de médecine du travail, 35, 4-5, Avril-Mai,(p 501-509).
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CAS No. 111-70-6

name= n-heptanol-1
Purity>97%

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
2500, 3500, 4100, 6150, 8200, 10250, 12300 mg/kg
No. of animals per sex per dose:
10 animals/sex/group
Control animals:
no
Details on study design:
After administration of the test item, the animals were submitted to a 2-weeks observation period and the mortality rate and clinical signs were recorded. Post-mortem examination was performed.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 6 200 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 5 500 mg/kg bw
Mortality:
Generally death appeared during the first 48 hours after dosing. No animals were found dead after the sixth days of dosing.
2500 mg/kg: no death.
3500 mg/kg : 1/10 males dead and 1/10 females dead,
4100 mg/kg: 2/10 males dead and 3/10 females dead,
6150 mg/kg : 6/10 females dead
8200 mg/kg: 3/10 females dead and 7/10 females dead,
10250 mg/kg: 8/10 males dead
12300 mg/kg: 9/10 males dead and 10/10 females dead.

Clinical signs:
Lung edema were observed in death animals at post-mortem examination.
Gross pathology:
Symptoms of acute lung edema were observed in the dead animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive EC No. 1272/2008
Conclusions:
The oral LD50 of Heptanol was 6200 +/- 700 mg/kg for males rats and 5500 +/- 500 mg/kg for the females.
Executive summary:

The acute oral toxicity study was evaluated in rats for n-heptanol-1. The acute toxicity was considered low for each of the males and the females. During the necropsy examinaqtion, signs of irritation were recorded for the lung parenchyma for the male rat. Indeed, acute edema of the lung was recorded for the animals found dead few hours after test item administration, this was substantiated by inflamation of the lung alveolar and hemosiderin deposits.In the males rats, congestion and inflammation of the lung were associated with lesions in the lungs but the incidence was not dose-related. In the females rats, kidney dilatation was observed at the highest dose-levels. No other effects were observed on the sampled organs.