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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23rd December 1998 to 24th March 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:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: pale yellow liquid
- Storage condition of test material: The test substance was stored at room temperature in the dark.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The animals bred by Charles River, were supplied by CRIFFA, S.A.
- Age at study initiation: Approximately 5 weeks
- Weight at study initiation: 108-124 g
- Housing: The animals were housed in Makrolon cages (55 x 32.7 x 19 cm) with sawdust bedding, each cage containing up to 5 rats of the same sex.
- Diet (e.g. ad libitum): standard rat diet UAR A04C (Batch 80609), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30-45%
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 13th January 1999 To: 5th February 1999

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was diluted in bidistilled water. The solutions were prepared immediately before the administration.
A single dose was given at a volume of 10 mL/kg.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Preliminary study: one group consisting of one female.
Main study: one group consisting of 5 animals/sex.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day the test substance was administered, the rats were frequently observed so as to record the clinical signs. Afterwards, the rats were observed at least twice a day for a 14-day period. All rats were weighed before administration, daily for the first three days and then weekly. At the end of the observation period the animals were weighed before being sacrificed.
- Necropsy of survivors performed: yes
- Other examinations performed: The necropsy included a revision of the intact animal and all its superficial tissues, followed by an observation of the cranial, thoracic and abdominal cavities both in situ and after evisceration.

Results and discussion

Preliminary study:
No mortality was recorded in the Preliminary Study animal, a single female treated at 2000 mg/kg.
This female, treated at 2000 mg/kg, did not present any clinical signs during the observation period.
The female showed a normal evolution of growth.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals treated at the dose of 2000 mg/kg died.
Clinical signs:
No clinical signs were observed in the animals administered at 2000 mg/kg.
Body weight:
All the animals treated at the dose of 2000 mg/kg presented a normal evolution of growth.
Gross pathology:
In the necropsies carried out, the animals administered with the test substance at the dose of 2000 mg/kg did not show any visible macroscopic lesions related to the treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It can be concluded that the substance is free of any significant toxicity. The oral LD50 is greater than 2000 mg/kg.
Executive summary:

The acute toxicity of the test substance was assessed following oral administration, in Sprague Dawley rats, by the fixed dose method. The method employed in this study adheres to the EU method B.1 bis and the OECD guideline 420.

The above-mentioned substance was administered at the dose of 2000 mg/kg.

None of the animals treated at the dose of 2000 mg/kg died in the course of the Study.

No clinical signs were observed in the animals administered at 2000 mg/kg.

In the necropsies carried out at the dose 2000 mg/kg no appreciable macroscopic alterations related to the treatment were observed.

It can be concluded that the substance is free of any significant toxicity. The LD50 is greater than 2000 mg/kg.