Registration Dossier

Diss Factsheets

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: This acute oral study is classified as reliable with restriction considering that the report is very succinct.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptanal
EC Number:
203-898-4
EC Name:
Heptanal
Cas Number:
111-71-7
Molecular formula:
C7H14O
IUPAC Name:
heptanal
Details on test material:
- Name of test material (as cited in study report): 74-12
- Substance type: C7 aldehyde
- Physical state: no data
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing:no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5 g/kg
No. of animals per sex per dose:
10 (no information on sex)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data
Statistics:
No statistics were performed.

Results and discussion

Preliminary study:
Not concerned.
Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
Lethargy and piloerection were reported.
Body weight:
no data
Gross pathology:
no data
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU and CLP classifications
Conclusions:
Under the conditions of this test, Heptanal did not induce any mortality among the animals at the tested dose level of 5000 mg/kg.
Executive summary:

In an acute oral toxicity study, 10 rats were given a single oral dose of heptanal at a dose level of 5000 mg/kg bw and observed for 14 days. No death occurred during the course of the study. Lethargy and piloerection were the only clinical signs reported. LD0 = 5000 mg /kg bw in rats.

Under the conditions of this test, heptanal is therefore not classified according to EU and GHS classifications.

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