Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no details to test item, some data concerning animals (breeder, acclimatization period) and enviromental conditions (humidity and air changes7h) are missing, frequency of observation not given, no details to autopsy result or any individual data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: /
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 113 g male and 131 g female
- Fasting period before study: 18h
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): /
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2 % aqueous solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 ml/kg bw

MAXIMUM DOSE APPLIED: 5000 mg/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex and dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: /
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and autopsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no
Clinical signs:
no
Gross pathology:
no findings

Any other information on results incl. tables

No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) in rats is greater than 5 g/kg bw. Therefore, no indication for acute toxicity is indicated.
Executive summary:

The test substance was tested for its acute toxicity potential in the standard acute test method, similar to OECD 401.

Five male and female Sprague-Dawley rats were individually housed. The test substance was administered in a carboxymethyl cellulose vehicle as a limit dose of 5000 mg/kg bw.

Animals were observed for clinical signs and an autopsy was performed at the end of the 14 day observation period.

There were no clinical symptoms observed and no animal died during the study. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

The acute oral median lethal dose (LD50) was greater than 5 g/kg body weight and the test substance is not considered acute toxic in rats.