Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report with basic details reported but sufficient to judge as meeting basic scientific priniciples and therefore reliable for with restrictions.
Principles of method if other than guideline:
Follows basic principles of an OECD401 but there is insufficient information to rank it as 'equivalent or similar'. A number of the observations normally now required are not reported.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Own colony
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90-120g
- Diet : Rockland rat diet
Route of administration:
oral: gavage
Vehicle:
other: see other information.
Doses:
Not specified. Doses were arranged in a logarithmic series with a factor of 2 between doses.
No. of animals per sex per dose:
5
Control animals:
other: A number of other substances were also tested in the same study
Details on study design:
Duration of observation period following administration: 14 days
Statistics:
LD50 value and precision estimated by method of Thompson (Bacteriol Rev, 11, 115, 1947) and tables of Weil (Biometrics, 8, 249 ,1952)
Sex:
female
Dose descriptor:
LD50
Effect level:
11.3 mL/kg bw
Remarks on result:
other: no data on confidence limits. LD50 is equivalent to 10,200mg/kg
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance of low toxicity by the oral route.
Executive summary:

In an old study report where basic but sufficient experimental details were reported, an LD50 of 10200mg/kg was established in female rats.

Synopsis

LD50 (male rats) = 10,200mg/kg

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 200 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
Best available data

Justification for classification or non-classification