Registration Dossier
Registration Dossier
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EC number: 203-564-8 | CAS number: 108-24-7
Acute Toxicity: oral
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: Acceptable study report wich meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- BASF-Test: In principle, the methods described in OECD Guideline 401 were used. 5 young male (mean body weight: 254 g) and 5 young female rats (mean body weight: 190 g) were used per dose group. The substance was applied as a single oral dose (10 ml/kg bw of an 3.16-31.6% emulsion of the test substance in olive oil). The post-exposure period was 14 days, after which the animals were sacrificed and subjected to a gross-pathological examination. Findings were recorded 1 h, 24 h, 48 h, 7 d and 14 d after application of the substance.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Acetic anhydride
- EC Number:
- 203-564-8
- EC Name:
- Acetic anhydride
- Cas Number:
- 108-24-7
- Molecular formula:
- C4H6O3
- IUPAC Name:
- acetyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Acetic anhydride
- Analytical purity: approx. 98%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Wiga, Sulzfeld
- Weight at study initiation: males 254 g, females 190 g (mean)
- Fasting period before study: 16 hours
- Diet (ad libitum): Herilan MHR-Kraftfutter (H. Eggersmann, Rinteln/Weser)
- Water (ad libitum): Yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Doses:
- 316, 464, 681, 1000, 1470, 2150, 3160 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 630 mg/kg bw
- Mortality:
- No animals died in the 316 mg/kg bw dose group. In the 464 mg/kg bw dose group, no animals died 1 h after substance application, one female animal was found dead after 24 h and an additional female was found dead after 14 days. In the 681 mg/kg bw dose group, no animals died after 1 h , 1/5 male animals was dead after 24 h, whereas 5/5 female animals were found dead after 24 h and no additional animals died until the end of the observation period (14 days). In the 1000 mg/kg dose group, 3/5 male and 3/5 female animals were dead after 24 h, but none died after 1 h and no additional animals died until the end of the observation period (14 days). In all other dose groups, no animals died after 1 h but 5/5 male and 5/5 female animals were dead after 24 h.
- Clinical signs:
- other: The animals of all dose groups showed dyspnea, apathy, staggering, atony, tremor, spastic movements, opisphotonus and diarrhea in varying degrees. Some animals assumed a lateral position.
- Gross pathology:
- Gross pathology revealed acute dilatation of the heart, acute hyperemia, acute gastritis and diarrheic content of the intestines with strong injection of the blood vessels in the sacrificed animals of the three highest dose groups; animals of the 1000, 681 and 464 mg/kg bw dose groups had dilatation of the heart, acute hyperemia, diffuse irritation of the stomach (gastritis) and additionally conglutination of the gastric mucosa with the liver, spleen, diaphragm and peritoneum in the 1000 mg/kg bw dose group. Substance precipitation in the abdomen was not observed in the 464 mg/kg bw dose group. Both sexes showed comparable results.
Any other information on results incl. tables
Dose(mg/kg bw) |
Mortality Dead/treated |
|||||||||
1 hour |
24 hours |
48 hours |
7 days |
14 days |
||||||
male |
female |
male |
female |
male |
female |
male |
female |
male |
female |
|
316 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
464 |
0/5 |
0/5 |
0/5 |
1/5 |
0/5 |
1/5 |
0/5 |
1/5 |
0/5 |
2/5 |
681 |
0/5 |
0/5 |
1/5 |
5/5 |
1/5 |
5/5 |
1/5 |
5/5 |
1/5 |
5/5 |
1000 |
0/5 |
0/5 |
3/5 |
3/5 |
3/5 |
3/5 |
3/5 |
3/5 |
3/5 |
3/5 |
1470 |
0/5 |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
2150 |
0/5 |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
3160 |
0/5 |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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