Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study, no GLP, short report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technically pure

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF-Zucht: Firma Gassner, Ottobrunn, Deutschland
- Age at study initiation: no data
- Weight at study initiation: male: ca 215 g; female: ca. 155 g
- Fasting period before study: no data

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS : no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 or 16 % (w/v; suspension)
- Amount of vehicle (if gavage): max. ca. 8,6 mL
- Justification for choice of vehicle: the test material is insoluble in all possible vehicles
- Lot/batch no. (if required): no data


MAXIMUM DOSE VOLUME APPLIED: ca. 8,6 mL
Doses:
200 - 1600 - 3200 - 6400 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 6 400 mg/kg bw
Based on:
test mat.
Mortality:
One male rat died about 7 days after treatment. The animal showed pneumonia during necropsy. The death was not considered as a consequence of treatment. Surviving animals also showed signs of pneumonia at necropsy.
Clinical signs:
Dyspnea and apathy were observed for 2 to 5 days.
Body weight:
no data
Gross pathology:
The deceased animal showed pneumonia during necropsy. Surviving animals also showed signs of pneumonia at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw after single, oral gavage in the rat.
Executive summary:

The acute oral toxicity of the test material was determined in Sprague-Dawley rats. The test material was suspended in an aqueous suspension of carboxymethyl-cellulose at 2 % (low dose) or 16 % (w/v; other doses). Doses employed were 200, 1600, 3200 and 6400 mg/kg applied orally by gavage.

The aproximate mean lethal dose (AID 50) was above 6400 rng/kg bw.