Oxaceprol

Endpoint summary

Description of key information

The LD50 of Oxaceprol in Sprague Dawley rats was determined to be > 2500 mg/kg b.w.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-03-03 to 2001-11-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996-03-22

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyowa Hakko Kogyo Co., Ltd. / lot 000703

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
For the purpose of the intradermnal phase of the study the test material was freshly prepared in distilled water and for the topical phase of the study the test material was freshly prepared in 90 % aqueous ethanol.

Species:

rat

Strain:

Sprague-Dawley

Remarks:

CD (Crl:CD (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: ca. 8 weeks
- Weight at study initiation: females 213 - 230 g; males 219 - 241 g
- Fasting period before study: overnight
- Housing: groups of 3 by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml
- Justification for choice of vehicle: no adverse effct by water
- Purity: distilled

MAXIMUM DOSE VOLUME APPLIED: 10 ml


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No adverse effect expected

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 172 h, 1 h, 2 h, 4 h after dosing and subsequently daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: There were no signs of systematic toxicity noted in the female animals. Hunched posture was noted in all male animals during the day of dosing with lethargy noted in 2 animals the day of dosing. All male animals appeared normal one day after dosing.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2500 mg/kg b.w. when applied to Sprague Dawley rats.

Executive summary:

The acute oral toxicity of Oxaceprol was assessed in an acute oral toxicity study (acute toxic class method) according to OECD 423.

Mortalities did not occur.

There were no signs of systematic toxicity noted in the female animals. Hunched posture was noted in all male animals during the day of dosing with lethargy noted in 2 animals the day of dosing. All male animals appeared normal one day after dosing.

No abnormalities were noted at necropsy.

The LD50 of Oxaceprol in Sprague Dawley rats was determined to be > 2500 mg/kg b.w.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

Klimisch 1

Justification for classification or non-classification

The LD50 of Oxaceprol in Sprague Dawley rats was determined to be > 2500 mg/kg b.w.