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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
BASF Test:
Young adult laboratory mice were used. The concentrations of the test substance were applied as a single interperitoneal dose. The post-exposure period was 14 days, after which the animals were sacrificed and subjected to gross-pathological examination. Groups of 5 male and 5 female mice were exposed to concentrations of the test substance as specified. Clinical symptoms were recorded immediately following injection, and 15 min, 30 min, 1 h, 2 h, 4 h, 5 h, 7 d and 14 d thereafter.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
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%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Firma Wiga, Sulzfeld
- Age at study initiation: not recorded
- Weight at study initiation: males 28 g, females 27 g (mean)
- Fasting period before study: approx. 16 hours
- Diet (ad libitum): Herilan MHR-Kraftfutter
- Water (ad libitum): yes


Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
olive oil
Doses:
46.4, 68.1, 100, 147 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. 50 mg/kg bw
Mortality:
No animals died in any dose group 1 hour after substance application. In the lowest dose group, 1/5 male animals were found dead after 24 h and 2/5 males and 1/5 females, 3/5 males and 1/5 females, 3/5 males and 1/5 females, respectively, after 48 h, 7 days and 14 days. In the 68.1 mg/kg bw dose group, 1/5 males was found dead after 48 h, whereas 4/5 males and 4/5 females died after 7 days; after 14 days all animals had died. In case of the 100 mg/kg bw group, 2/5 males died after 24 h, 4/5 males and 2/5 females after 48 h and 5/5 males and 5/5 females after 7 days. 5/5 males and 3/5 females were found dead after 24 hours and all animals of that dose group had died after 48 h.
Clinical signs:
The animals of all dose groups showed dyspnea, apathy, staggering, paresis of the hind legs, twitching, tremor, spastic movements, convulsions in varying degrees and deteriorated general state.
Body weight:
not recorded
Gross pathology:
Gross pathological examination revealed an agglutinated liver in case of the two low dose groups and intraabdominal substance precipitation in case of one male of the 68.1 mg/kg bw dose group, but not in case of the two female animals of the same dose group; substance precipitation was also found in animals of the 100 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

46.4

0/5

0/5

1/5

0/5

2/5

1/5

3/5

1/5

3/5

1/5

68.1

0/5

0/5

0/5

0/5

1/5

0/5

4/5

4/5

5/5

4/5

100

0/5

0/5

2/5

0/5

4/5

2/5

5/5

5/5

5/5

5/5

147

0/5

0/5

5/5

3/5

5/5

5/5

5/5

5/5

5/5

5/5

Applicant's summary and conclusion