Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2002/04/15 to 2002/05/16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline and in compliance with GLP.

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 (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Deutschland GmbH, D-97633, Sulzfeld

- Age at study initiation: 42-48 days

- Weight at study initiation: Males 210-219 g; Females 179-193 g

- Fasting period before study: Yes - 16 hours

- Housing: MAKROLON cages (Type III)

- Diet (e.g. ad libitum): ssnif R/M-H V 1530 ad libitum

- Water (e.g. ad libitum): ad libitum

- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 ± 3

- Humidity (%): 55 ± 15

- Air changes (per hr): No information

- Photoperiod (hrs dark / hrs light): 12


IN-LIFE DATES: From: 15th April 2002 To: 16th May 2002

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.54 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Guideline
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: 15 mins, 1, 3, 6 and 24 hours after dosing and daily thereafter for clinical observations; weekly for weighing

- Necropsy of survivors performed: Yes

- Other examinations performed: clinical signs, body weight, macroscopic examinations
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
All animals of each sex showed clinical signs of toxicity including slightly reduced motility, slight ataxia, slightly reduced muscle tone and slight dypsnoea up to 1 hour after administation of the test material.
Body weight:
All animals gained the expected body weight over the study period.
Gross pathology:
No macroscopic abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral LD50 value of >2000 mg/kg bw was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.