Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28th May to 22nd June 1999 for males, 2nd July to 28th July for females
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in 1999 in accordance with OECD guideline 420 although not in accordance with GLP. The batch number (807007) and purity (100%) are both noted in the report. A statement of authentication is also provided in the report in lieu of a more formal Quality Assurance procedure. The study is well reported with regards to both the methodology and results. One animal died during the study but no explanation attributing the cause of death is made within the report. There were no abnormalities detected upon necropsy. Due to the lack of observed effects this deviation is not considered to affect the reliability of the study.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 weeks old
- Weight at study initiation: 215-252 g for males and 171-195 g for females
- Fasting period before study: Overnight (18 to 20 hours)
- Housing: Group caged by sex, 2 or 3 animals in each cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 25 days for males, 10 days for females

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 30-70 %
- Air changes (per hr): Approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
soya oil
Details on oral exposure:
VEHICLE
- Amount of vehicle: 1 mL/100 g bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 males and 5 females dosed with the test material
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: The animals were observed at least once daily, the animals were weighed prior to dosing and on days 7 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.
Mortality:
No mortality occcurred in the males dosed with the test material. One female was found dead on day 2.
Clinical signs:
There were no treatment related clinical signs.
Body weight:
All surviving animals showed expected bodyweight gains during test period.
Gross pathology:
There were treatment related necropsy findings. No abnormaltities of the abdominal and thoracic cavities were observed. No abnormalities were observed in animals sacrificed at the end of the study.

Any other information on results incl. tables

Table 1: Results

Sex

Dose (mg/kg)

Number of Rats

Age and Weight (g) at Dosing

Mortality

Male

2000

6

7 weeks old, 215-252 g

0/6

0 (control)

1

0/1

Female

2000

5

7 weeks old, 171-195 g

1/5

0 (control)

1

0/1

Combined

2000

11

7 weeks old, 171-252 g

1/11

0 (control)

2

0/2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the LD50 of the test material was found to be greater than 2000 mg/kg bw in male and female Wistar rats.
Executive summary:

In a study conducted to OECD 420, the acute oral toxicity of the test material was investigated in male and female Wistar rats using a limit dose of 2000 mg/kg bw. Only one mortatlity was noted during the course of the study, and no treatment related changes were apparent. Under the conditions of the test, the LD50 of the test material was determined to be greater than 2000 mg/kg bw.