H112323

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr-Mar, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted equivalent or similar to EU Method B.1. and OECD Guideline 401 in compliance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): H112323
- Physical state: Dark blue powder

Test animals

Species:

rat

Strain:

other: Crl:(WI)BR strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent, UK
- Age at study initiation: 7-8 wk males and 9-10 wk females
- Weight at study initiation: 176-198 g (males) and 191-212 g (females)
- Fasting period before study: Yes, 24 h
- Housing: Suspended cages (26.5cm x 50.0cm x 20.7cm) made of stainless steel, one side being solid and the remainder wire mesh
- Diet (e.g. ad libitum): Porton Combined Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2 °C
- Humidity (%): 55±25 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): Test substance was suspended in corn oil. The volume of the dose was calculated for each animal according to its weight at the time of dosing, and was adjusted for water content,

Doses:

2000 mg/kg bw (adjusted for water content)

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded once within 2 h of dosing and again between 4 and 7 h after dosing on the day of dosing and there after once a day up to Day 15. The animals were weighed on Day -1, 1 3, 4, 8 and 15.
- Necropsy of survivors performed: yes; animals were killed by inhalation of excessive levels of halothane vapour followed by exsanguination

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: -

Mortality:

No mortalities occurred during the whole study.

Clinical signs:

other: There were no significant signs of toxicity

Gross pathology:

No significant gross pathology changes observed

Other findings:

No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute oral medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of test substance in wistar rats equivalent or similar to EU Method B.1. and OECD guideline 401 in compliance with GLP.

A group of five male and five female rats received a single oral dose of 2000mg/kg (adjusted for water content) of the test sample as a preparation in corn oil. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.

None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. The acute oral median lethal dose was in excess of 2000mg/kg to male and female rats.

Under the test conditions, the acute oral medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.