reaction product of: saturated, monounsaturated and multiple unsaturated long-chained partly estrified alcohols of vegetable origin (Brassica napus L., Brassica rapa L., Helianthus annuus L., Glycine hispida, Gossypium hirsutum L., Cocos nucifera L., Elaeis guineensis) with O,O-diisobutyldithiophosphate and 2-ethylhexylamine and hydrogen peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 29, 1992 to January 19, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in accordance with recognised guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

428-630-5

EC Name:

-

Molecular formula:

Not applicable

IUPAC Name:

reaction product of Z-9-octadecen-1-ol and O,O-diisobutyl hydrogen dithiophosphate

Details on test material:

- Name of test material (as cited in study report): Becrosan 6920
- Physical state: clear, brown liquid
- Lot/batch No.: 395 1
- Expiration date of the lot/batch: December 3 1,1993
- Storage condition of test material: ambient
- Other:

Test animals

Species:

rat

Strain:

other: Han: WIST (Syn: Wistar), white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
zentralinstitut fiir
Versuchstierzucht GmbH
Hermann-Ehlers-Allee 57
W-3OOO Hannover 91


- Age at study initiation:


- Weight at study initiation: m: 207 - 238 g, f: 156 - 187 g


- Fasting period before study: The animals were fasted from 16 h before until 3 - 4 h after administration of the test article.


- Housing: collective housing u to a maximum of 5 animals per cage (Makrolon8 t ype 111)


- Acclimation period: at least 5 days

- Diet: ad libitum

- Water: ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.


IN-LIFE DATES: NDA

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Not applicable

Doses:

The test article was administered undiluted in a volume of 2.04 ml/kg, or 2000 mg/kg

No. of animals per sex per dose:

5 /sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined at the following post-treatment intervals: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight no further details available

Statistics:

An estimate of the acute oral median lethal dose (LD50) of the substance was made using the mortality data obtained.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0

Clinical signs:

other: No abnormal clinical signs were observed.

Gross pathology:

Gross pathological examinations at 14 days p. a. (terminal necropsy) revealed no test articledependent findings. Those macroscopic changes observed were attributable to the sacrificing procedure or to minor variations which can occur spontaneously in rats of this strain and age.

Other findings:

- Organ weights: No Data Available
- Histopathology: No Data Available
- Potential target organs: No Data Available
- Other observations:No Data Available

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the requirements of the limit test, the LD50 values after 24 h and 14 days were as follows: male and female > 2000 mgkg

Executive summary:

INTRODUCTION AND AIM

The aim of the test was to determine the acute median lethal dose of "Becrosan 6920". Information derived from this test serves to indicate the existence of possible hazards likely to arise from short-term exposure to the test article by the oral route.

The test was conducted according to the OECD guideline for the testing of chemicals OECD 401 (February 24, 1987) and the EEC directive 84/49 EEC (September 19, 1984). The study was carried out as described in the corresponding protocol approved by the testing facility and the study sponsor on November 25 and 30, 1992, respectively. The principles of Good Laboratory Practice for the testing of chemicals as specified by national (BGB1. I, no. 13,Q 19 a, March 22, 1990) and international (OECD, Paris, 1982) legislation were followed during the performance of the study.

SUMMARY

The acute oral toxicity of"Becrosan 6920"was investigated in 5 male and 5 female Wistar rats.

On the basis of the range finding results, the animals were given a single oral administration of"Becrosan 6920"at a dose of 2000 mg/kg.

Clinical observations were conducted at regular intervals during the 14-day observation period. Gross pathological examinations were performed on all animals 14 days p.a.

Body weights were measured at days 0,7and 14 days p.a.

 

The following results were obtained:

1. No abnormal clinical signs were observed.

2. Weight gains were normal in all animals.

3. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article -dependent findings.

4. According to the requirements of the limit test, the LD50 values after 24 h and 14 days were as follows: male and female > 2000mgkg

5. The above value is higher than the limit specified as harmful by the EEC directive

91/325/EEC and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBl. I, p. 2721).

When administered by the oral route, the test article "Becrosan 6920” may therefore be classified as "non-toxic".