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Description of key information

Oral (OECD 401), rat: LD50 >2000 mg/kg bw

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:
15 Jul - 11 Aug 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Council Directive 84/449/EEC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 5-8 weeks
- Weight at study initiation: 155-171 g (males), 150-161 g (females)
- Fasting period before study: overnight prior to administration until approx. 2 h after dosing
- Housing: up to 5 animals of the same sex per cage in solid-floor polypropylene cages on sawdust
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 48-66
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.12 mL/kg bw

A range-finding study was performed to derive the dose level of the main study.
Doses:
Preliminary study: 2000 mg/kg bw
Main study: 2000 mg/kg bw
No. of animals per sex per dose:
Preliminary study: 1
Main study: 5
Control animals:
no
Details on study design:
Range-finding study:
- Duration of observation period following administration: 5 days
- Frequency of observations: Animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 h after administration and subsequently once daily for 5 days.
- Necropsy of survivors performed: no

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths and overt signs of toxicity 0.5, 1, 2 and 4 h after administration and subsequently once daily for 14 days. Individual body weights were determined prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
Preliminary study:
No deaths were noted at 2000 mg/kg bw. Incidents of hunched posture were noted in the female 2 to 4 h after treatment. The dose level selected for the main study was therefore 2000 mg/kg bw.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period of the main study.
Clinical signs:
No signs indicative for systemic toxicity were noted during the main study.
Body weight:
In the main study, animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value > 2000 mg/kg bw was derived in male and female rats.
Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1993). Following a range-finding study, 5 male and 5 female rats were given a single oral dose of 2000 mg/kg bw. No mortality occurred and thus aLD50 value of >2000 mg/kg bw was derived.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1993). Following a range-finding study, 5 male and 5 female rats were given a single oral dose of 2000 mg/kg bw. No mortality occurred and thus a LD50 value of >2000 mg/kg bw was derived.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.