Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 February 1999 - 16 June 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
yes
Remarks:
no deviations that were considered to have affected the integrity or validity of the study
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
yes
Remarks:
no deviations that were considered to have affected the integrity or validity of the study
GLP compliance:
yes
Remarks:
expiry date of the test item is not indicated
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature in the dark and at 4 °C in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 105 - 137 g
- Fasting period before study: yes
- Housing: 3 rats (same sex) / cage
- Diet: standard laboratory rodent diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: minimum 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 27 -52
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 or 20%
- Amount of vehicle: 10 mL/kg bw
Doses:
200 and 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations; twice daily; Weighing: On Days 1 (prior to dosing), 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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:
There were no deaths in groups of six rats (three males and three females) following an oral administration of the test substance at dosages of 200 and 2000 mg/kg bodyweight.
Clinical signs:
Piloerection was observed in all rats within four minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or at later intervals during the study by; hunched posture notable in all rats treated at 200 or 2000 mg/kg, with waddling/unsteady gait and dark colouring to eyes in all rats at 2000 mg/kg, soft to liquid faeces and ungroomed appearance in one male and all females at 2000 mg/kg and protruding eyes in all females at 200 mg/kg and one female at 2000 mg/kg. Recovery, as judged by external appearance and behaviour, was complete in all rats by Day 6.
Body weight:
All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No abnormalities were revealed at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met