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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

The study was performed according to EG Guideline B.1. 84/449/EWG, OECD 401 and GLP.
The LD50 to male and female rats of the test item was determined to be greather than 2000 mg/kg body weight.

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
Study period:
1989-10-11 to 1989-11-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed according to EG Guideline B.1. 84/449/EWG, OECD 401 and GLP.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: Starch slime 2%
Doses:
3 dose concentrations:
Male: 1600 mg/kg, 2000 mg/kg, 2500 mg/kg bw
Female: 2000 mg/kg bw

4'000 mg/kg
5'000 mg/kg
6'300 mg/kg
8'000 mg/kg
No. of animals per sex per dose:
5 animals per dose
Male and female rats used.
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Results:

Dose Level in mg/kg bw

Male animals

mortality

Female animals

mortality

 

absolute

relative (%)

absolute

relative (%)

1600

0 / 5

0

-

-

2000

2 / 5

40

0 / 5

0

2500

2 / 5

40

-

-

 

 
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 to male and female rats of the test item was determined to be greather than 2000 mg/kg body weight.
Executive summary:

The study was performed according to EG Guideline B.1. 84/449/EWG, OECD 401 and GLP.

The LD50 to male and female rats of the test item was determined to be greather than 2000 mg/kg body weight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
Study was performed according to EG Guideline B.1. 84/449/EWG, OECD 401 and GLP.

Justification for classification or non-classification

Based on the data available the substance is not classified according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).