Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant Guideline study.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
other: HanBrl: Wist (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd. CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: males - 8 weeks; females - 10 weeks
- Fasting period before study: 17 to 18 hours
- Housing: in groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3422 rat maintenance diet, ad libitum
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 5. Feb. To: 31. Jan. 2002

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: based on solubility testing
- Lot: 424718/1 42701

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Number of animals per group: 3 males or 3 females
Total number of animals: 3 males, 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs - daily
body weights - day 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Median lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days
Mortality:
No death occurred during the study.
Clinical signs:
No clinical signs were noted during the course of the study.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings 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:
The median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is LD50 (rat) > 2000 mg/kg body weight.
Executive summary:

The acute oral toxicity of the test substance to rats was investigated in a study conducted according to OECD Guideline 423. The median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is LD50 (rat) > 2000 mg/kg body weight.