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: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 29, 1992 - 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

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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

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-Alee 57
3000 Hannover 91

- Age at study initiation: no data

- Weight at study initiation: m: 218 - 247 g, f: 169 - 191 g

- Fasting period before study: None

- Housing: individual housing in cages (Makrolon@ type 11)

- Diet (e.g. ad libitum): 2014 Teklad Global Rodent Diet. ad libitum

- Water (e.g. ad libitum):ad libitum

- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- Type of wrap if used: with a porous gauze dressing and Elastoplast" (Beiersdorf).


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none.
- Time after start of exposure:not applicable


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test article was applied undiluted in a volume of 2.04 ml/kg, or 2000 mg/kg
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A


VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of exposure:

24 h

Doses:

Single dose level of 2000 mg/kg bodywight

No. of animals per sex per dose:

5m, 5f, dosed at 2000 mg/kg bw

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 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.

- Frequency of observations and weighing: Body weights were recorded immediately before treatment (day 0) and on days 7 and 14 p.a. (termination).

- Necropsy of survivors performed: The animals were sacrificed by C02 asphyxiation after 14 days and gross pathological examinations were subsequently performed.

- Other examinations performed: clinical signs, body weight, dermal irritation

Statistics:

Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.

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 article-dependent findings. That macroscopic change observed was 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 signs of erythema and oedema were observed.

Any other information on results incl. tables

Under the experimental conditions described above, the following results were obtained.

Range finding

There were no deaths in the preliminary study

Main study

Pre-tenninul deaths

No animals died during the course of the main study.

Clinical observations

No abnormal clinical signs were observed.

Body weight

Weight gains were normal in all animals.

Skin reactions

No signs of erythema and oedema were observed.

Necropsy

Gross pathological examinations at 14 days p. a. (terminal necropsy) revealed no test article-dependent findings. That macroscopic change observed was attributable to the sacrificing procedure or to minor variations which can occur spontaneously in rats of this strain and age.

 LD50 values

According to the requirementsofthe limit test, theLD50values after 24 h and 14 days were as follows:male and female>2000mgkg

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 > 2000mgkg

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 dermal route.

The test was conducted according to the OECD guideline for the testing of chemicals OECD 402 (February 24, 1987) and to theEECdirective 84/449/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. The principles of Good Laboratory Practice for the testing of chemicals as specified by national (BGB1.I,no 13,919 a, March 22, 1990) and international (OECD, Paris, 1982) legislation were followed during the performance of the study.

 

SUMMARY

The acute dermal toxicity of "Becrosan 6920" was investigated in5male and5female Wistar rats.

On the basis of the range finding results, each animalwasgiven a single dermal administration of "Becrosan 6920" at a dose of 2000 mg/kg body weight. The skin was exposed to the test article for 24 h and signs of erythema and oedema were subsequently evaluated once daily for 14 days.

Clinical observations were conducted at regular intervals during the 14-day observation period. Body weights were measured at days 0, 7 and 14 p.a. Gross pathological examinations were performed on animals at termination.

 

The following results were obtained:

1. No abnormal clinical signs were observed.

2. No signs of erythema and oedema were observed.

3. Weight gains were normal in all animals.

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

5.According to the requirements of the limit test, the LD50 values after 24 h and

14days were as follows:male and female > 2000 mgkg

6.The above value is higher than the limit specifiedasharmful by the EEC directive 91/325/EEC and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBL.1 p. 2721). When applied to the skin, the test article"Becrosurz 6920"may therefore be classifiedas"non-toxic".