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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source from OECD SIDS
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
No information
Author:
French J.E. (NTP):
Year:
1986
Bibliographic source:
The Toxicologist, 6, 298, (1986)
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: NTP protocol
Principles of method if other than guideline:
NTP range-finding study
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butyraldehyde
- Molecular formula (if other than submission substance): Not documented
- Molecular weight (if other than submission substance): 72.1
- Smiles notation (if other than submission substance): Not documented
- InChl (if other than submission substance): Not documented
- Structural formula attached as image file (if other than submission substance): see Fig. Not documented
- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 98.59 % by weight
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: Not documented
- Isomers composition: Not documented
- Purity test date: Not documented
- Lot/batch No.: Not documented
- Expiration date of the lot/batch: Not documented
- Radiochemical purity (if radiolabelling): Not documented
- Specific activity (if radiolabelling): Not documented
- Locations of the label (if radiolabelling): Not documented
- Expiration date of radiochemical substance (if radiolabelling): Not documented
- Stability under test conditions:Not documented
- Storage condition of test material: Not documented
- Other: Not documented

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
No information provided

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Vehicle = corn oil
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No information on verification of concentrations
Duration of treatment / exposure:
12 days
Frequency of treatment:
Once a day, 5 days a week for a total of 12 treatments.
Doses / concentrations
Remarks:
Doses / Concentrations:
156; 313; 625; 1250; 2500 mg/kg
Basis:
no data
No. of animals per sex per dose:
Not documented
Control animals:
yes, concurrent vehicle
Details on study design:
Post-exposure period: 1 day
Positive control:
Not documented

Examinations

Observations and examinations performed and frequency:
Not documented
Sacrifice and pathology:
Not documented
Other examinations:
Not documented
Statistics:
Not documented

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
Gastric lesions (erosion, ulceration, inflammation and hyperplasia) were dose-related. The NOEL for rats and mice was 625 mg/kg/day.
Dose or concentration at which no toxic effects were observed: 625 mg/kg/day

Effect levels

Dose descriptor:
NOEL
Effect level:
625 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Gastric lesions (erosion, ulceration, inflammation and hyperplasia) were dose-related. The NOEL for rats and mice was 625 mg/kg/day. Dose or concentration at which no toxic effects were observed: 625 mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The results of this study indicate an NOEL of 625mg/kg bw /day under the conditions adopted in this study
Executive summary:

In the study conducted by French et al (1986), Fischer 344 rats were exposed to butyraldehyde administered orally by gavage in corn oil for a total of 12 dose days. The findings of this study included gastric lesions (erosion, ulceration, inflammation and hyperplasia) which were considered to be dose-related. The dose or concentration at which no toxic effects were observed was determined to be 625 mg/kg/day, meaning the NOEL was 625 mg/kg bw/day.