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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:
June from 7th to 30th, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 5 to 8 weeks old
- Weight at study initiation: males 157 - 171 g; females 140 - 157 g.
- Fasting period before study: overnight fast immediately before dosing.
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet, ad libitum.
- Water: ad libitum.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 42 - 57 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
TEST MATERIAL
- Preparation: test material was freshly prepared, as required, as a suspension at the appropriate concentration in distilled water. The concentration, homogeneity and stability of test material preparation were not determined by analysis.
- Concentration: 200 mg/ml
- Dose volume: 10 ml/kg. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 male and 1 female for range-finding
5 males and 5 females for main test
Details on study design:
RANGE-FINDING
- Duration of observation: the animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days.
- Frequency of observations and weighing: individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes.
- Necropsy of survivors performed: no necropsies were performed.

MAIN STUDY
- Duration of observation: the animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Frequency of observations and weighing: individual bodyweights were recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: animals were killed by cervical dislocation and subiected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
RANGE-FINDING
No deaths occurred.

MAIN STUDY
No deaths occurred.
Clinical signs:
RANGE-FINDING
No clinical signs of toxicity were recorded.

MAIN STUDY
Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted.
Red-coloured staining of the fur was noted in all males.
Body weight:
MAIN STUDY
AII animals showed expected gain in bodyweight during the study.
Gross pathology:
MAIN STUDY
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 (rat) > 2000 mg/kg bw
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD guideline 401. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.

There were no deaths. Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

Conclusion

LD50 (rat) > 2000 mg/kg bw