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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
153812-94-3
Test material form:
liquid
Details on test material:
Name of the test substance used in the study report: Beta-Formylcrotonsaeuremethylester
Purity: > 95%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Acclimatization period: at least one week
Animals of a comparable weight were used.
Animal identification using cage cards (group identification).
Five animals per cage (type: stainless steel wire mesh cages, DK-III).
They were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum. Food depreviation 16 hours before test substance administration (water was available ad libitum).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
The test substance was sensitive to hydrolysis.
Form of administration: solution
Concentrations used: 9.28, 20 and 40 g/100 ml
Administration volume: 5 ml/kg
Doses:
464, 1000 and 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation period: 14 days
Recording of signs and symptoms several times on the day of test substance administration (at least once each workday). Check for moribund and dead animals twice each workday and once on public holidays.
Withdrawal of food about 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die as soon as possible.
Statistics:
slope factor calculated accord to Finney, DJ, probit analysis, Cambridge University Press, 3rd ed., 1971

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 410 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 660 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 200 mg/kg bw
Mortality:
Males: 464 and 1000 mg/kg: no deaths; 2000 mg/kg: 4/5 after 14 days
Females: 464 mg/kg: no deaths; 1000 mg/kg: 1/5 after 14 days; 2000 mg/kg: 5/5 after 14 days
Clinical signs:
Dyspnea, apathy, abnormal position (females only), staggering, piloerection, diarrhea, salivation (females only), poor general state
Body weight:
Mean body weight male animals: 185.3 g at study start, 258.3 g after 13 days
Mean body weight female animals: 183.3 g at study start, 212.0 g after 13 days
Gross pathology:
Animals that died: glandular stomach: multiple hemorrhagic erosions in some animals; hyperemia of mucosa with edema in most of the animals.
Sacrificed animals: forestomach: wall thickening, intra-abdominal adhesions (1000 and 2000 mg/kg); low dose level: no pathologic findings noted.

Applicant's summary and conclusion