2-butenoic anhydride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-butenoic anhydride

EC Number:

210-807-1

EC Name:

2-butenoic anhydride

Cas Number:

623-68-7

Molecular formula:

C8H10O3

IUPAC Name:

(2E)-but-2-enoyl (2E)-but-2-enoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, SPF breeding colony
- Females (if applicable) nulliparous and non-pregnant: [yes/no] yes
- Age at study initiation: male 6-8 wk, female 8 wk
- Weight at study initiation: male mean = 182 g+-15
female mean = 173 g +- 6
- Fasting period before study: no data
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff® R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least one day (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h daily

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil (Oleum sesami)

Doses:

The following dose levels of Crotonsäureanhydrid were tested:

Dose Concentration Volume applied Number of
mg/kg b.w. in % (w/v) (ml/kg body weight) males females
1250 12.5 10 5
1600 16.0 10 5 -
1800 18.0 10 5 -
2000 20.0 10 5 5
2500 25.0 10 5 -

Control animals:

no

Statistics:

The LD50, the 95 % limits of confidence and the equation of the probitline were established in male animals on the basis of the lethality rates by probit analysis.
(method of FELLER and SIDAK, programs supplied by Pharma Informatic, Hoechst Aktiengesellschaft).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 061 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 847 - <= 2 512

Mortality:

Under the conditions described above, the following lethality rates were observed:

Lethality
Dose male animals female animals
mg/kg b.w. absolute relative (%) absolute relative (%)

1250 0/5 0
1600 0/5 0
1800 0/5 0
2000 4/5 80 0/5 0
2500 4/5 80

Gross pathology:

Macroscopic examination of the animals found dead revealed the following findings:
- liver light discoloured
- kidneys light discoloured
- diffuse reddening of the stomach mucosa
- stomach full of gas
- diffuse reddening of the intestinal tract
- diffuse reddening of the small intestine
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of Crotonsäureanhydrid was calculated by probit analysis for the male Wistar rat to be 2061 mg/kg body weight.