[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Adopted 17 Dec. 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 177 +/- 6.7 g
- Fasting period before study: yes
- Housing: transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 10. June To: 25. June 2003

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Tylose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: homogenity, stability

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual):
the test item was suspended in tylose and distributed homogeneously by means of a magnetic stirrer

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to toxicity data of related compounds

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (2 x 3 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Symptoms: twice daily
Body weight: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

Feces was discolored by compound one day after the administration, no symptoms of toxicity were observed

Body weight:

not impaired

Gross pathology:

no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this OECD 423 study with female rats the LD50 of the test item is greater than 2000 mg/kg bw.

Executive summary:

Acute oral testing of the test item in famels rat yielded a LD50 greater than 2000 mg/kg be. After administration of 2000 mg/kg bw neither deaths nor symptoms occurred. Only the feces was discolored by the test compound on day 2 of the study. Development of body weight was not impaired. All animals were killed at the end of the observation period. They showed no macroscopically visible changes.