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Administrative data

Description of key information

rat oral LD50 > 2000 mg/kg

dermal: data waiving

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:
March 02, 1994 - May 30, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
none
Clinical signs:
uncoordinated movements in all animals 4 hours after dosing
Body weight:
no effect
Gross pathology:
no abnormalities
Other findings:
none
Interpretation of results:
GHS criteria not met
Conclusions:
rat oral LD50 > 2000 mg/kg (both sex)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
inhalation exposure is not likely taking into account the vapor pressure of the substnace and the conditions of use in the workplace, e.g. the likelihood of exposure with an aerosol.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
A dermal LD50 study does not need to be conducted as the result of an acute oral toxicity study does not meet the criteria for classification as well as an primary skin irritation study did not meet the criteria for classification. Thus, no systemic toxicity is predicted after single dermal exposure (the rat dermal LD50 is most probably >2000 mg/kg bw).

Additional information

Justification for classification or non-classification