Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-10 to 2002-08-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
other: Crl: CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: males - 42 days; females - 50 days
- Weight at study initiation: males - 219 - 244 g; females - 193 - 200 g
- Fasting period before study: none
- Housing: in groups of 2-3 in MAKROLON cages
- Diet: Standard diet for rats and mice ssniff R/M-H V1530, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55 % +/- 15 %
- Photoperiod (hrs dark / hrs light): 12/ 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.87 mL/ kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the dose used was selected from a series of defined dose levels
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made before and immediately, at 5, 15, 30 and 60 minutes, as well as at 3, 6, 24 hours after administration. Body weights were recorded before administration and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes. At the end of the study period all the animals were sacrificed, dissected and inspected macroscopically.
- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity as well as behaviour pattern were observed at least once a day until all the symptoms subsided, thereafter each working day. Attention was also paid to tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Statistics:
No statistics were used in the study.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the 14-day study period.
Clinical signs:
No clinical signs of systemic toxicity were noted during the 14-day study period.
Body weight:
Expected body weight gain was noted in all the animals during the 14-day study.
Gross pathology:
No macroscopic abnormalities were observed at post mortem examination.
Other findings:
There were no other findings in the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, an LD50 value of > 2000 mg/kg bw was reported.
Executive summary:

In the acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, an LD50 value of > 2000 mg/kg bw was reported.

A single dose of 2000 mg/kg bw of undiluted test substance was administered orally to 3 male and 3 female rats. Observations were made before and immediately, at 5, 15, 30 and 60 minutes, as well as at 3, 6, 24 hours after administration. Body weights were recorded before administration and thereafter in weekly intervals up to the end of the 14 -day study. At the end of the study period all the animals were sacrificed, dissected and inspected macroscopically.

No mortality occurred during the 14 -day study period. No signs of systemic toxicity were noted. No macroscopic abnormalities were observed at necropsy.