POLYPERINY

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-04-29 - 1996-07-02 (experimental phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Storage condition of test material:
room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK.
- Weight at study initiation: body weight: female: 129 - 148 g, male: 141 - 171 g
- Age of test animals: 5 - 8 weeks
- Fasting period before study: overnight before administration, 2 hours after dosing
- Housing: 5 rats per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 48 - 58
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Arachis Oil BP
- Concentration in vehicle: 200 mg test substance per ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg bw: 5 female rats, 5 male rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (5000 mg/kg bw)
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Preliminary study:

There were no deaths. Red/brown-coloured faeces were noted in both animals one day after dosing. Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

Acute oral toxicity was analyzed in a GLP study performed according to OECD test guideline 401. Five male and female Sprague-Dawley CD rats received doses of 2000 mg/kg bw by gavage. Since no mortality was noted during the 14-day observation period, the LD50 was found to be >2000 mg/kg bw. Due to the observed LD50 in a study performed equivalent to OECD guideline, no classification according EU and GHS criteria is required according Directive 67/548/EC or EU GHS criteria (Regulation (EC) N° 1907/2006).