Registration Dossier

Administrative data

Description of key information

The test item was tested for its acute oral toxicity potential. 5 male and 5 female rats were treated with doses of 1000, 3100 or 5000 mg/kg bw and observed for 14 days.
The median lethal dose of test item (LD50) was 3100 mg per 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:
Aug - Sept 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well reported study, performance equivalent to OECD Guideline 401 with some minor restrictions.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Necropsy was not performed in all surviving animals
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: 170 g (males), 167 g (females)
- Fasting period before study: Animals were fasted from 16 h before application until 4 h after application. During this period tap water was available.
- Housing: Groups of five animals were housed in Makrolon cages type III with dustfree wood pellets as bedding material.
- Diet: Altromin R 1324, Altromin GmbH, Germany, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1,5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
1000, 3100 or 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were periodically observed for clinical signs on the treatment day and twice daily thereafter until the end of the observation period. Body weights were recorded right before application and weekly thereafter.
- Necropsy of survivors performed: yes, on a random basis
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 100 mg/kg bw
Remarks on result:
other: 5/10 animal died at 3100 mg/kg bw (2 males and 3 females)
Mortality:
No mortality occurred in the 1000 mg/kg bw group. In the 3100 mg/kg bw group, 2/5 males and 3/5 females died during the first 2 days after application of the test substance. In the 5000 mg/kg bw group, 4/5 males and 4/5 females were found dead during the first 4 hours after application of the test substance.
Clinical signs:
Clinical signs were observed in all dose groups. The general condition of all animals was decreased and they layed down in side or prone position and showed signs of sedation and anaesthesia. These symptoms were fully reversible within 2 days.
Gross pathology:
Necropsy of surviving animals on a radom basis revealed no substance-related findings. No necropsy or histopahological examination was done in the animals that died during the observation period.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of the test substance (LD50) was 3100 mg per kg body weight. Based on the result of this study the substance is not subject for labelling and classification requirements according to regulatory requirements.
Executive summary:

The test item was tested for its acute oral toxicity potential. 5 male and 5 female rats were treated with doses of 1000, 3100 or 5000 mg/kg bw and observed for 14 days.

The median lethal dose of test item (LD50) was 3100 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 100 mg/kg bw
Quality of whole database:
reilable with restrictions

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
Well reported study, performance equivalent to OECD Guideline 401 with some minor restrictions.

Justification for classification or non-classification

Based on the result of a the acute oral toxicity study the substance is not subject for labelling and classification requirements according to regulatory requirements.