Captan

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 August 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Captan

EC Number:

205-087-0

EC Name:

Captan

Cas Number:

133-06-2

Molecular formula:

C9H8Cl3NO2S

IUPAC Name:

2-[(trichloromethyl)sulfanyl]-2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Physical state: white powder- Purity: 90.5 %
- Batch number: 4102
- Date of arrival: 9 July 1991
- Storage conditions: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- one female New Zealand white rabbit
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- weight: 2.7 kg- age: approximately twelve to sixteen weeks old
- free access to mains drinking water and food
- animal room temperature: 20 - 23°C- humidity: 56%

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A single dose of 82 mg (equivalent to 0.1 mL) captan (purity not specified in report; Batch no. 4102) was administered.

Duration of treatment / exposure:

5 hours

Observation period (in vivo):

Assessment of ocular damage was made at 1 and 5 hours

Number of animals or in vitro replicates:

one female

Details on study design:

Material and methods: A single dose of 82 mg (equivalent to 0.1 mL) captan (purity not specified in report; Batch no. 4102) was administered into the elevated lower lid of the right eye of one female New Zealand white rabbit. Immediately after administration of the test material, an assessment of the initial pain reaction was made. Assessment of ocular damage was made at 1 and 5 hours following administration according to Draize (1959).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Assessment of ocular damage/irritation of the solid powder (test material) was made approximately 1 and 5 hours following treatment, according OECD 405 (1987), Method B.5 (Commission Directive 84/449/EEC) and Draize J.H. 1959.

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Assessment of ocular damage/irritation of the solid powder (test material) was made approximately 1 and 5 hours following treatment, according OECD 405 (1987), Method B.5 (Commission Directive 84/449/EEC) and Draize J.H. 1959.

Results 3

Irritation parameter:

conjunctivae score

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Assessment of ocular damage/irritation of the solid powder (test material) was made approximately 1 and 5 hours following treatment, according OECD 405 (1987), Method B.5 (Commission Directive 84/449/EEC) and Draize J.H. 1959.

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Assessment of ocular damage/irritation of the solid powder (test material) was made approximately 1 and 5 hours following treatment, according OECD 405 (1987), Method B.5 (Commission Directive 84/449/EEC) and Draize J.H. 1959.

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Assessment of ocular damage/irritation of the solid powder (test material) was made approximately 1 and 5 hours following treatment, according OECD 405 (1987), Method B.5 (Commission Directive 84/449/EEC) and Draize J.H. 1959.

Results 6

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 5 h

Score:

43

Max. score:

80

Reversibility:

not reversible

Remarks on result:

probability of moderate irritation

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 h

Score:

0

Max. score:

80

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 5 h

Score:

20

Max. score:

80

Reversibility:

not reversible

Results 9

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

5

Max. score:

10

Reversibility:

not reversible

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 5 h

Score:

5

Max. score:

10

Reversibility:

not reversible

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

16

Max. score:

20

Reversibility:

not reversible

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 5 h

Score:

18

Max. score:

20

Reversibility:

not reversible

Any other information on results incl. tables

A dulling of the normal lustre of the corneal surface was noted in the treated eye one hour after treatment with areas of diffuse corneal opacity at the 5 hour observation. Iridial Inflammation was noted in the treated eye one and 5 hours after treatment. Severe conjunctival Irritation was noted in the treated eye one and 5 hours after treatment. Haemorrhage of the nictitating and conjunctival membranes was also noted in the treated eye at the 5 hour observation.

Table 7.3.2-1  Ocular irritation in the rabbit

Rabbit: female, number #1	IPR 2
		Draize grade:
Time after Treatment		1 h	5 h
Tissue	Signs
Cornea	E = Degree of Opacity	d	1
	F = Area of Opacity	4	4
Score (E x F) x 5		0	20
Iris	D = Iritis	1	1
Score (D x 5)		5	5
Conjunctiva	A = Redness	2	2^H
	B = Chemosis	3	4
	C = Discharge	3	3
Score (A + B + C) x 2		16	18
Total Score		21	43

IPR: Initial Pain Reaction

d: dulling of the normal lustre of the corneal surface

H: haemorrhage of the nictitating and conjunctival membranes

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

There was no evidence of recovery during the observation period following administration of the test substance since the study was terminated after 5 hours. In accordance the provisions of regulation 1272/2008, Annex I, 3.3 captan is classified as eye damaging category 1 with the hazard statement H318: Causes serious eye damage

Executive summary:

A study was performed to assess the irritancy potential of captan to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as EEC method B.5 published in the regulation 440/2008. A single application of the test material to the non-irrigated eye of one rabbit produced areas of diffuse corneal opacity, iridial inflamm ation and severe conjunctival irritation. Other adverse ocular reactions noted were a dulling of the normal lustre of the corneal surface and haemorrhage of the nictitating and conjunctival membranes. The animal was killed for humane reasons immediately after the five hour observation in accordance with current U.K. Home Office guidelines. The test material produced a maximum total score of 43. There was no evidence of recovery during the observation period following administration of the test substance since the study was terminated after 5 hours. In accordance the provisions of regulation 1272/2008, Annex I, 3.3 captan is classified as eye damaging category 1 with the hazard statement H318: Causes serious eye damage