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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 25 - June 5, 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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: yellow liquid
- Lot/batch No.: 4567
- Expiration date of the lot/batch: April 31,1994
- Storage condition of test material: ambient

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever; Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Fasting period before study: None
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): 2030 Teklad Global Rabbit diet. ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 2O +/- 3 °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: No data available

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%

VEHICLE
- Amount(s) applied (volume or weight with unit):None
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of treatment / exposure:

4 hours

Observation period:

Animals were examined for signs of skin reactions at 30-60 min, 24, 48 and 72 h after patch removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Dorsal, ca. 6 cm2 in size
- % coverage: No Data Available
- Type of wrap if used: Each test area was covered with a semi-occlusive dressing consisting of Ypsiplast@ (Holthaus Medical, Remscheid- Luttringhausen), which was held in place by non-irritating tape Elastoplast@ (Beiersdorf AG, Hamburg), and Stiilpa@ (P. Hartmann AG, Heidenheim-Brenz), which enveloped the whole of the animal's trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 4 hours after application

SCORING SYSTEM: Evaluation of skin reactions (as stipulated by OECD 404); Skin reactions were classified with special consideration to the EEC directive 91/325/EEC of March 1, 1991 and GefStoffV, 1987 (BGBl. I, p. 2721).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30-60 min

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30-60 min

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no adverse effect

Irritant / corrosive response data:

See table below for Individual Skin Reactions

Other effects:

None.

Any other information on results incl. tables

PH of the substance is not available.

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

Table I: Individual values of skin reactions

Animal #	Time after patch removal
	30-60 min				24h				48 h				72h
	Ery		Oed		Ery		Oed		Ery		Oed
	T	C	T	C	T	C	T	C	T	C	T	C	T	C	T	C
1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

 

T= test site

C= control site

Ery= erythema

Oed = oedema

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is considered as not irritating according to the EU criteria for classification.

Executive summary:

INTRODUCTION AND AIM

The aim of the test was to assess the irritant and/or corrosive effect of "Becrosan 6920"on the skin. Information derived from this test serves to indicate the existence of possible hazards likely to arise from exposure of the skin to the test article.

The test was conducted according to the OECD guideline for the testing of chemicals no. 404 (May 12, 1981) and the EEC directive 84/449/EEC (September 19, 1984). The study was carried outasdescribed in the corresponding protocol approved by the testing facility and the study sponsor on April 28 and 30, 1993, respectively. The principles of Good Laboratory Practice for the testing of chemicalsasspecified by national (BGB1. I, no. 13,Q19a, March 22, 1990) and international (OECD, Paris, 1982) legislation were followed during the performance of the study.

SUMMARY

The potential toxicity of"Becrosan 6920"was assessed in an acute dermal initationkorrosion test on 3 albino rabbits. The skin was exposed to the test article for 4 h. Animals were examined for signs of erythema and oedema at 30-60 min, 24,48 and 72 h after patch removal.

Clinical observations

No test article-dependent findings were observed.

Assessment

The mean grades of skin reactions at 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991 and the  Gefahrstoffverordnung (GefStoffV), 1987 (BGB1. I, p. 2721). When applied to the skin for 4 h, the test article"Becrosan 6920"may therefore be considered to ben on-irritant.