Reaction products of 2,4,6-trichloro-1,3,5-triazine copuled with 3-aminopropyldiethylamine, coupled with 3-acetamidoanilinium chloride, diazotised, coupled with 2,5-Xylidine, coupled with 3-amino-4-hydroxybenzenesulphonamide, further coupled with resorcinol and metallized with iron chloride.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Basic Brown 022

IUPAC Name:

Basic Brown 022

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: animals were housed in single cages.
- Diet: laboratory diet was provided ad libitum. The batch of the diet used for the study was analysed for chemical and microbiological contaminants.
- Water: water was provided ad libitum.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
- Health check: prior to the test, the eye of each rabbit were examined for pre-existing casual injury.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg of the test material was placed into the conjunctival sac of the animals.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not rinsed.

SCORING SYSTEM:
The eyes were inspected after 30 min., 24, 48 and 72 hours.
Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (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: 3/3

Time point:

24/48/72 h

Score:

> 1 - < 3

Results 2

Irritation parameter:

iris score

Basis:

animal: 2/3

Time point:

24/48/72 h

Score:

>= 1 - < 1.5

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

> 2

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

> 2

Irritant / corrosive response data:

The irritation score resulted to be 51.4.

Any other information on results incl. tables

Animal no	Reaction	30 min	24 hrs	48 hrs	72 hrs	Mean 24/48/72 hrs
304	Cornea opacity	0	2	3	3	2.67
	Iris	0	1	1	2	1.33
	Conjuntival chemosis	0	3	3	2	2.67
	Conjuntival redness	1	3	3	3	3.00
305	Cornea opacity	0	1	3	3	2.33
	Iris	0	0	1	2	1.00
	Conjuntival chemosis	0	3	3	2	2.67
	Conjuntival redness	1	3	3	3	3.00
306	Cornea opacity	0	2	3	2	2.33
	Iris	0	0	1	1	0.67
	Conjuntival chemosis	0	3	3	2	2.67
	Conjuntival redness	1	3	2	2	2.33

Animal no	Reaction		30 min	24 hrs	48 hrs	72 hrs
304	Cornea	(A) density	0	2	3	3
		(B) area	0	4	4	4
		AxBx5	0	40	60	60
	Iris	(C)	0	1	1	2
		Cx5	0	5	5	10
	Conjunctiva	(D) secretion	1	1	1	1
		(E) swelling	0	3	3	2
		(F) redness	1	3	3	3
		(D+E+F)x2	4	14	14	12
305	Cornea	(A) density	0	1	3	3
		(B) area	0	4	4	4
		AxBx5	0	20	60	60
	Iris	(C)	0	0	1	2
		Cx5	0	0	5	10
	Conjunctiva	(D) secretion	1	1	1	2
		(E) swelling	0	3	3	2
		(F) redness	1	3	3	3
		(D+E+F)x2	4	14	14	14
306	Cornea	(A) density	0	2	3	2
		(B) area	0	4	4	4
		AxBx5	0	40	60	40
	Iris	(C)	0	0	1	1
		Cx5	0	0	5	5
	Conjunctiva	(D) secretion	1	1	1	2
		(E) swelling	0	3	3	2
		(F) redness	1	3	2	2
		(D+E+F)x2	4	14	12	12

Applicant's summary and conclusion

Interpretation of results:

other: Eye. Irrit. 2 (H319), according to the CLP Regulation (EC 1272/2008)

Conclusions:

Eye irritating

Executive summary:

The eye irritation potential of the test item was tested using three rabbits (New Zealand white Rabbits). 100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals. The left eye served as control.

The eyes were inspected after 30 min., 24, 48 and 72 hours. Treated eyes were not rinsed after application of the test item.

Reading scores for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

The irritation score resulted to be 51.4.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were in the range of 1 - 3 for corneal opacity, ≥ 1 - < 1.5 for iritis, higher than 2 for both conjunctival redness and chemosis, in at least two out of three rabbits. No information about the reversibility was available.

Based on the effects observed, the substance is considered as irritating to eye and a classification in category 2 (Eye. Irrit. 2, H319) of the CLP Regulation (EC 1272/2008) is considered as appropriate.