Acid Brown 432:2

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Study period:

Oct. 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

Artificial lighting sequence is 10 hours dark, 14 hours light

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

400-320-4

EC Name:

-

Cas Number:

94933-05-8

Molecular formula:

not applicable

IUPAC Name:

Reaction products of diazotised anthranilic acid coupled with resorcinol and diazotised 5-aminonaphthalene-1-sulphonic acid, metallised with Chromium (III) basic sulphate, sodium salts

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, England
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.44 to 2.70 kg
- Gender: female; nulliparous and non-pregnant
- Housing: individual grid floor cages
- Diet: ad libitum; SQC Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex, England
- Water: ad libitum (analytical test report demonstrates suitability)
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 21 °C
- Humidity: 48 to 62 %
- Air changes per hour: not specified
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 rabbits (female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 24 h

SCORING SYSTEM: Grading of Ocular Lesions, OECD Guideline for the Testing of Chemicals, Test No. 405: Acute Eye Irritation/Corrosion, 2017
- Irritation scores of each animal at 1, 24, 48 and 72 hours and 7 days were measured.
- The scoring systems found in "Any other information on materials and methods", below, was used to assess eye damage parameters.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corrosive effects were observed.

Other effects:

COLOURATION
Hair adjacent to the treated sites was stained brown by the test item.

Any other information on results incl. tables

Table 1: Individual conjunctivae, iris and corneal irritation scores.

Animal number and gender	Body weight (kg)	Time after treatment	Conjunctiva			Iris	Cornea		Score			Total score
			Redness	Chemosis	Discharge		Opacity	Area	(a+b+c)×2	d×5	e×f×5
			a	b	c	d	e	f
573F	2.44	1 hour	2	2	1	0	0	0	10	0	0	10
		1 day	2	0	0	0	0	0	4	0	0	4
		2 days	1	0	0	0	0	0	2	0	0	2
		3 days	1	0	0	0	0	0	2	0	0	2
		7 days	0	0	0	0	0	0	0	0	0	0
574F	2.70	1 hour	2	2	2	0	0	0	12	0	0	12
		1 day	2	0	0	0	0	0	4	0	0	4
		2 days	1	0	0	0	0	0	2	0	0	2
		3 days	1	0	0	0	0	0	2	0	0	2
		7 days	0	0	0	0	0	0	0	0	0	0
575F	2.64	1 hour	2	1	1	0	0	0	8	0	0	8
		1 day	2	0	0	0	0	0	4	0	0	4
		2 days	1	0	0	0	0	0	2	0	0	2
		3 days	1	0	0	0	0	0	2	0	0	2
		7 days	0	0	0	0	0	0	0	0	0	0

Table 2: Mean eye irritation scores.

Time after treatment	Mean scores
	Conjunctiva (max 20)	Iris (max 10)	Cornea (max 80)	Mean total scores (max 110)
1 hour	10.0	0.0	0.0	10.0
1 day	4.0	0.0	0.0	4.0
2 days	2.0	0.0	0.0	2.0
3 days	2.0	0.0	0.0	2.0
7 days	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

other: not classified accoring to the CLP Regulation (EC 1272/2008)

Conclusions:

The test item was not found to be an Eye Irritant or an Eye Corrosive.

Executive summary:

The eye irritation potential of the test item was evaluated in an experimental study comparable to the OECD Guideline 405 (1981). 100 mg of moistened test item was administered to the inside of the lower, left eyelid of three female New Zealand albino rabbits and rinsed with warm water after 24 hours. Animals were monitored for corneal capacity, iritis, conjunctival redness and oedema at 1, 24, 48 and 72 hours and 7 days after the application of the test item. The right eye received no treatment, therefore was considered a negative control.

Mean (24, 48 and 72 hour) conjunctival redness scores were 1.33 in all three animals, however this effect was reversible within 7 days. Corneal opacity, iritis and chemosis scores were 0 at all time points and for all three animals. Slight brown staining of the hair adjacent to the eye was observed. No corrosive effect was observed.