Butyraldehyde

Repeated dose toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

No information

Author:

French J.E. (NTP):

Year:

1986

Bibliographic source:

The Toxicologist, 6, 298, (1986)

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: NTP protocol

Principles of method if other than guideline:

NTP range-finding study

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Butyraldehyde

EC Number:

204-646-6

EC Name:

Butyraldehyde

Cas Number:

123-72-8

Molecular formula:

C4H8O

IUPAC Name:

butanal

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 or test system 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.