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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EEC (Fixed- dose procedure)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-090-2
EC Name:
-
Cas Number:
86087-23-2
Molecular formula:
C4 H8 O2
IUPAC Name:
(3S)-oxolan-3-ol

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000mg/kg
No. of animals per sex per dose:
Preliminary sighting study: 2 (male)
Preliminary sighting study: 2 (female)
Main study: 5 (male)
Main study: 5 (female)
Control animals:
no
Details on study design:
Main study:
2000mg/kg

Results and discussion

Preliminary study:
Species/strain: Rat (Wistar)
2000 mg/kg bw: Evident toxicity: N; Mortality: N
500 mg/kg bw: Evident toxicity: N; Mortality: N
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Clinical signs:
other: Signs of toxicity: None of the animals died and there were no signs of toxicity. All animals gained weight during the study.
Gross pathology:
Effects on organs:
There were no abnormalities at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of 1272W94 was evaluated in Wistar rats using OECD Guideline 420 "fixed dose method". The LD50 was estimated to be >2000mg/kg bodyweight.
Executive summary:

The acute oral toxicity of 1272W94 was evaluated in Wistar rats using OECD Guideline 420 "fixed dose method". Following a preliminary study when there were no deaths at dose levels of 500mg/kg and 2000mg/kg, a group of 5 fasted male and 5 fated female Wistar rats were given 2000mg/kg of undiluted material by oral gavage.The animals were observed for 14days following dosing and were then killed and subject to gross necrospy. There were no deaths or clinical signs of toxicity and all animals showed expected weight gains during thye study period. No abnormalities were observed at necropsy and the acute oral LD50 was estimated to be >2000mg/kg bodyweight.in the Wistar strain rat.