PIGMENTADDITIV RL

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 11 Apr 1989 to 14 Apr 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 405), according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 24 February 1987)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(Commission Directive 84/449/EEC, adopted 25 April 1984)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.3-2.9 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay (about 15g/day)
- Water: deionised, chlorinated water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as internal control

Amount / concentration applied:

100 mg/eye

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24 and 72 h after administration) took place
- Time after start of exposure: 24 h

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0.2

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not relevant since no effects

Irritant / corrosive response data:

Slight conjunctivae redness was observed in all animals one hour after application, but was no longer detectable in two animals at the 24 h reading. Only one animal revealed conjunctivae redness at the 24 h reading, but not at later time points (for details see table below). Chemosis (score 1 or 2) was observed in all animals one hour after application of the test item, but not at later time points. Iris and cornea were not affected.
A black discharge was observed in all animals at the 1 h reading. Diffuse crimson coloured conjunctivae was observed in one animal at 24 hours. No signs of irritation were apparent after 48 hours.

Any other information on results incl. tables

 

Time point after application	1 h			24 h			48 h			72 h
Animal no.	#1	#2	#3	#1	#2	#3	#1	#2	#3	#1	#2	#3
Cornea	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae redness	1	1	1	2	0	0	0	0	0	0	0	0
Chemosis	1	2	2	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was not irritating to the eyes of rabbits under the conditions of this test.

Executive summary:

The primary irritation potential of the test item was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits according to OECD TG 405 (adopted 24 February 1987) and GLP. The treated eyes were rinsed with distilled water approximately 24 hours after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application.

Slight conjunctivae redness was observed in all animals one hour after application, but was no longer detectable in two animals at the 24 h reading. Only one animal revealed conjunctivae redness at the 24 h reading, but not at later time points. Chemosis (score 1 or 2) was observed in all animals one hour after application of the test item, but not at later time points. Iris and cornea were not affected. A black discharge was observed in all animals at the 1 h reading. Diffuse crimson coloured conjunctivae was observed in one animal at 24 hours. No effects were observed at the 48 h and 72 h reading. Due to the only sligth, reversible effects observed under the conditions of this test the test item was judged not to be irritating to the eyes.