Registration Dossier

Administrative data

Description of key information

Male and Female rats were subjected to test acute oral toxicity according to OECD TG 401. The test item was administered at dose levels of 1 000 and 5 000 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period no animals died and there were no abnormalities found in necropsy, thus leading to an LD50 > 5 000 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:
20.09.1978 - 05.10.1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
according to OECD 410, but limited documentation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Fasting period before study: 15-20 h before administration
- Weight at study initiation: 210 - 300 g (males); 180 - 200 g (females)

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% suspension
Details on oral exposure:
- Concentration in vehicle: 10 and 50 % (w/v)
- Diet (e.g. ad libitum): Herlian MRH-Haltung, Eggersmann KG

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
1000 and 5000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obwervations: 1 h, 1, 2, 7, 14 days; weighing: at the beginning of the study, after 2 to 4, 7 and 14 days
- Necropsy of survivors performed: yes/
- Other examinations performed: clinical signs, body weight, organs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortalities
Clinical signs:
orange staining of the urine (high dose level) and diarrhea (both dose levels)
Body weight:
Body weights were within the range commonly recorded for this strain
Gross pathology:
Necropsy revealed no findings
Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) 1272/2008
Conclusions:
Single application of 5 000 mg test item per kg bw did not cause lethality in male and female rats during the 14 days observation period, resulting in a LD50 > 5 000 mg/kg bw.
Executive summary:

Male and Female rats were subjected to test acute oral toxicity according to OECD TG 401. The test item was administered at dose levels of 1 000 and 5 000 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period no animals died and there were no abnormalities found in necropsy, thus leading to an LD50 > 5 000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
reliable with restrictions (sodium salt tested instead of acid)

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 classification or non-classification