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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 2 - 7,1993.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study; well documented study report

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 BremerviSrde, Neuendamm 88
- Age at study initiation: No data available
- Weight at study initiation:No data available
- 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):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 2O +/- 3"C
- Humidity (%): 30 - 70 %
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%

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 treatment / exposure:

Not washed.

Observation period (in vivo):

Ocular reactions were assessed 1, 24,48 and 72 h after treatment.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: all scores were zeros.

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: all scores were zeros.

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: all scores were zero.

Irritant / corrosive response data:

See below section.

Other effects:

none.

Any other information on results incl. tables

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

Table 1: Individual values of oculurgradings

Animal Number	Ocular lesion	Time after treatment (h)
		1		24		48		72
		T	C	T	C	T	C	T	C
1	Cornea	0	0	0	0	0	0	0	0
	Iris	0	0	0	0	0	0	0	0
	Conjunctivae redness	2	0	0	0	0	0	0	0
	Conjunctivae chemosis	1	0	0	0	0	0	0	0
2	Cornea	0	0	0	0	0	0	0	0
	Iris	0	0	0	0	0	0	0	0
	Conjunctivae redness	2	0	0	0	0	0	0	0
	Conjunctivae chemosis	1	0	0	0	0	0	0	0
3	Cornea	0	0	0	0	0	0	0	0
	Iris	0	0	0	0	0	0	0	0
	Conjunctivae redness	2	0	0	0	0	0	0	0
	Conjunctivae chemosis	1	0	0	0	0	0	0	0

 

 

Table 2: Mean values of ocular reactions at 24,48 and 72 h afer treatment (test site)

Animal Number	Cornea	Iris	Conjunctivae
			redness	chemosis
1	0	0	0	0
2	0	0	0	0
3	0	0	0	0

 

 

Clinical observations

Redness and chemosis of the conjunctivae were apparent in all animals up to 1 h p.a.

Reversibility

The observed findings were reversible within 24 h p.a.

Toxic effects other than ocular irritation

No other toxic effects were observed.

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean grades of ocular reactions at 24, 48 and 72 h p.a. (see Table 2) were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991 and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBl. I, p. 2721). When applied to the eye, the test article "Becrosan 6920" might therefore be considered to be non-irritant.

Executive summary:

INTRODUCTION AND AIM

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

The test was conducted according to the OECD guideline for the testing of chemicals no. 405 (February 24, 1987) and to 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 chemicals as specified by national (BGB1. I, no 13, $19 a, 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 eye irritationlcorrosion test on 3 albino rabbits. In each animal, 0.1 ml of the test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control, Both eyes were examined at 1, 24, 48 and 72 h post application.

Clinical observations

All animals showed conjunctival redness and chemosis which were reversible within 24 h p.a. Toxic effects other than ocular irritation were not observed.

Assessment

The mean grades of ocular reactions at 24,48 and 72 h p.a. were lower than the value classified as irritant by the EEC directive 91/325/EEC of March 1, 1991 and the Gefahrstoffverordnung (GefStoffV), 1987 (BGBl. I, p. 2721). When applied to the eye, the test article"Becrosan 6920"

might therefore be considered to be non-irritant.