Phenothiazine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-12-30 to Feb 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Remarks:

GLP declaration attached to full study report.

Test material

Test material information

Constituent 1

Reference substance name:

Phenothiazine

EC Number:

202-196-5

EC Name:

Phenothiazine

Cas Number:

92-84-2

Molecular formula:

C12H9NS

IUPAC Name:

10H-phenothiazine

Details on test material:

- Label: CA 794
- Desciption: pale yellow coloured crystalline solid
- Date of arrival: 28 November 1986
- Storage conditions: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leichestershire, UK and David Percival, Moston, Sandbach, Cheshire, UK
- Weight at start of study: 2.86 - 3.25 kg
- Age at start of study: 12 - 16 weeks
- Acclimatisation: min 5 days
- Identification: Ear mark and cage label
- Housing: Suspended metal cages
- Diet: Rabbit Diet, Preston Farmers Ltd., New Leake, Boston, Lincolnshire, UK, ad libitum
- Water: drinking water, ad libitum
- Room temperature: 17 - 18°C
- Relative humidity: 45 - 50 %
- Air exchange rate: 15 per hour
- Lighting: 12 hours light, 12 hours darkness

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: yes: Untreated eye was used as control.

Amount / concentration applied:

- A volume of 0.1 ml of the test material which was found to weigh 86.6 mg

Duration of treatment / exposure:

acc. to guideline.

Observation period (in vivo):

1 hour, 24, 48 and 72 hours following treatment.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
Scoring according to Draize J.H., 1959 Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: Max. score @ 1hr

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: Max. score @ 1hr

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: Max. score @ 1hr

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Iridial inflammation was confined to two treated eyes one hour after treatment. No iridal effects were noted at subsequent observations.
Conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 hour observation, but was confined to minimal conjunctival redness in one treated eye at the 48-hour observation. All treated eyes were normal at the 72-hour observations.

Any other information on results incl. tables

Individual and mean scores for Cornea, Iris & Conjunctivae

Rabbit number	Time after treatment [h]	Cornea opacity	Iridial effects	Conjunctival redness	Conjunctival chemosis
124	1	0	0	2	1
	24	0	0	1	0
	48	0	0	1	0
	72	0	0	0	0
	TOTAL 24, 48 & 72 hrs	0	0	2	0
	Mean *	0.0	0.0	0.7	0
137	1	0	1	2	1
	24	0	0	1	0
	48	0	0	0	0
	72	0	0	0	0
	TOTAL 24, 48 & 72 hrs	0	0	1	0
	Mean *	0.0	0.0	0.3	0.0
135	1	0	1	2	1
	24	0	0	1	0
	48	0	0	0	0
	72	0	0	0	0
	TOTAL 24, 48 & 72 hrs	0	0	1	0
	Mean *	0.0	0.0	0.3	0.0
(*) Individual mean of 24, 48 and 72-hour readings

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was found to be non-irritant to the rabbit eye according to EEC labelling regulations and requires no symbol or risk phrase.

Executive summary:

Summary

The potential for eye irritation/corrosion of the test substance was investigated by applying the test substance to the eyes of 3 New Zealad White rabbits.

No evidence of eye irritation was noted during the study period.

The test material was found to be a non-irritant to the rabbit eye according to the EEC labelling regulations and requires no symbol or risk phrase.