Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug. 20, 1981 to Sep. 8, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif:RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy premises
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 182-200 g for males and 168-178 g for females
- Fasting period before study: overnight before treatment
- Housing: groups of 5 in Macrolon cages (type 3), marked individually
- Diet (e.g. ad libitum): NAFAG No. 890, NAFAG, Gossau SG ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 55+/-10%
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5% carboxymethyl-cellulose + 0.1% Polysorbat 80
Details on oral exposure:
Animals were treated orally, with a single dose by means of a stomach tube.
Doses:
1000, 2500, and 5000 mg/kg body wieght
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Clinical signs of toxicity, physical condition, and rate of death was monitored throughout the 14-day observation period.
The animals were submitted to a necropsy whenever they died, survivors at the end of the observation period.
Body weights were recorded immediately prior to dosing (control weights) and at days 7 and 14.
Statistics:
No statistics were performed.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
1 male in high-dose group died 2 days after treatment. 5 (all) females in the high dose group died (4 at 24 hours and 1 on day 3).
Clinical signs:
Clinical signs observed were dyspnea, exophthalmos, ruffled fur and curved body position. These clinical signs are common ef¬fects in this type of study. Beside that, some cases of sedation were observed within the first day after treatment. Additionally, convulsions were detected in animals treated with 5000 mg/kg bw. All surviving animals recovered within seven days
Body weight:
No significant changes reported.
Gross pathology:
No test-article related changes were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acute oral LD50 was reported to be 2500 mg/kg body weight. The authors reported the test article to be slightly toxic to the rat by this route of adminstration.
Executive summary:

In this guideline (OECD 401) comparable study, the acute LD50 of the test material to rats was determined to be 2500 mg/kg bw via the oral route. A single dose of the test material was given to each animal (5 male, 5 female) via gavage. Animals were observed for 14 days from dosing. The result of the test does not trigger classification of the test material as acutely toxic under the criteria of the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).