Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-06-24 - 1992-08-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: albino rats (Tif: RAI f (SPF))
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Stein, Switzerland
- Weight at study initiation: 181 - 210 g
- Housing: Group-housed in Macrolon cages type 4 with standardized soft wood bedding; animals were identified with numbers from 1 to 5 using picric acid stain on the fur
- Diet: Standard diet, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: At least for 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Air conditioning: 15 air changes per hour
- Photoperiod: 12 hour/day light cycle

IN-LIFE DATES: From: 1992-07-14/1992-07-27 To: 1992-07-28/1992-08-10

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Details on oral exposure:
VOLUME APPLIED: 20 mL/kg bw
Doses:
2000 mg/kg bw (males and females)
No. of animals per sex per dose:
5 rats
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Observations and records:
Mortality: daily
Signs and symptoms: daily
Body Weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
Statistics:
Body weight: Group means and standard deviations

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The following death rate was observed: 0 % at 2000 mg/kg.
Clinical signs:
Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 6 to 7 days.
Body weight:
The body weight gain of the animals was not affected.
Gross pathology:
A spotted thymus was found in one female. No deviations from normal morphology were found in the remaining animals.

Any other information on results incl. tables

Based on the observations, oral LD50 value was to be greater than 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In an acute oral toxicity study groups of male and female rats (5/sex) were given a single oral gavage dose of the test item (as described in section 1.2) in a standard vehicle at a limit dose of 2000 mg/kg bw and observed for 14 days. No mortality occurred. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 6 to 7 days. The body weight gain of the animals was not affected. A spotted thymus was found in one female. No deviations from normal morphology were found in the remaining animals. Based on these observations, the oral LD50 value of the test item was greater than 2000 mg/kg bw.
Oral LD50: > 2000 mg/kg bw (per sex and combined)

This study is classified as acceptable. It satisfies the guideline requirement for an acute oral toxicity study according to OECD 401.