Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standards.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Directive 67/548
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Morini - S. Polo d'Enza
- Weight at study initiation: 140-200 g
- Housing: 5 animals of same sex in polycarbonate cages, indentified by coloring with indelible ink on various areas of the body
- Diet (e.g. ad libitum): complete pellet diet
- Water (e.g. ad libitum): purified water, ad libitum



ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/ml



MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg


DOSAGE PREPARATION (if unusual): test substance was dissolved in warm water

Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals of each sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made daily, body weights were taken before the beginning of the study, on day 7, and at study termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
Piloerection was observed in several of the animals during days 3 and 4 of the study.
Gross pathology:
One male rat showed redness in the stomach. Another male rat showed bloating in the stomach.

Any other information on results incl. tables

Results of Acute Oral Toxicity Study – Body Weights (g)

Animal

Initial Body Weight

Final Body Weight

Males

1

150

205

2

155

210

3

150

205

4

170

215

5

175

215

Females

1

170

215

2

165

210

3

170

215

4

175

220

5

145

190

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for male and female rats is >5000 mg/kg bw. The test substance is not classified as toxic under EU GHS guidelines.
Executive summary:

This study examined the acute toxicity of the test substance to rats. 5 male and 5 female rats were given a dose of 5000 mg/kg bw of test substance by oral gavage. The animals were then monitored for the next 14 days for mortality and signs of toxicity. At the end of the study, the animals were sacrificed and gross pathology performed. No animals died during the study. The LD50 for rats by oral exposure is > 5000 mg/kg bw. The test substance is not classified as toxic under EU GHS guidelines.