Registration Dossier

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:
other: GLP and guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994
Reference Type:
other: re-evaluation
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. certificate)
Remarks:
testiing lab.
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: Acryloxibutylchlorformiat
- Purity: ca. 75%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Young adult male and female rats with a comparable weight were used.
One animal per cage (type: stainless steel wire mesh cages, DK-III); animal identification using cage cards and group identification by tail marking.
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 dark.
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum.
The animals were given no feed at least 16 hours before administration (water was available ad libitum).
Acclimatization period: at least one week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
The test substance is sensitive to hydrolysis.
Form of administration: solution
Concentrations used: 4 and 40 g/100 ml
Administration volume: 5 ml/kg
Doses:
200, 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Observation period: 14 days
Individual body weights were recorded shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period).
Recording of signs and symptoms several times on the day of administration, at least once each working day.
A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.
Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy of all animals that died before as soon as possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: see attached document
Mortality:
Male animals: 200 mg/kg: no deaths; 2000 mg/kg: 1/3
Female animals: 200 mg/kg: no deaths; 2000 mg/kg: 1/3
Clinical signs:
Impaired and poor general state, dyspnea, apathy, staggering, twitching (females only), spastic gait, piloerection, smeared fur, diarrhea, smeared fur in the anogenital region (males only)
Body weight:
Mean body weights male animals: 180 g at study start, 273 g after 13 days
Mean body weights female animals: 179 g at study start, 218 g after 13 days
Gross pathology:
Animals that died: agonal congestion
Sacrificed animals: no pathologic findings noted

Applicant's summary and conclusion