Reaction products of diazotised 5-aminonaphthalene-1-sulfonic acid, coupled with diazotised 1-naphthylamine and 8-anilinonaphthalene-1-sulphonic acid, potassium sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read across from analogous substance

Adequacy of study:

key study

Study period:

From September 04 to September 11, 1990

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:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Slight modifications from the guidelines (e.g. more accurate description and scoring of corneal defects, additional axamination of aqueosus humor) do not affect the validity of this study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black BD:1-Similar Substance 01 (A)

Molecular formula:

N/A

IUPAC Name:

Acid Black BD:1-Similar Substance 01 (A)

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd. England
- Number of animals: 3
- Female: nulliparus and nonpregnant
- Weight of animals: 3.6 Kg, 3.7 Kg and 4.0 Kg (before the application)
- Randomization: by a number generator software
- Identification: ear marks (tatoo) and cage cards
- Preventive treatment: no vaccinationsor treatment with antibiotics
- Housing: individual stainless steel cages with flat rod bases or plastic cages with perforated bases. Excrement trays beneath the cages contained low-dust (wood) bedding (type S 8/15, Ssniff Spezialdiaten GmbH, Soest). Bedding was regularly spot-checked for contaminants and changed at least twice weekly.
- Diet: ad libitum, Standard diets "Ssniff K 4", (Ssniff Spezialdiaten GmbH, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
- Water: tap water; ad libitum.
- Analytical check of nutritive composition, contaminan-content and water for bacteria and contaminants was performed regularly.
- Acclimation period: at least 14 days. During this period pooled faeces specimens were examined for Coccidia oocysts.
- Observation of animals: daily

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 %
- Air changes (per hr): air-conditioned room, filtered
- Photoperiod (hrs dark / hrs light): 12 hours per day
- Irradiance. 27 Watt/m^2
- Air exchange: 10 times/hour
The humidity and air temperature were continuously recorded using a calibrated thermohygrograph (type 252, Lambrecht Co.,Gottingen).
- Cleanings: at least once per month, except for the room floor which was cleaned once per week, and disinfected with Zephirol® 10 % (1 % in water).
The drinking apparatus was cleaned once a week.

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

Amount / concentration applied:

100 µl of pulver (approx. 30 mg)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 female

Details on study design:

TEST SITE
- Area of exposure: conjuntival sac of one eye. The lids were gently held together for about one second in order to limit loss of the material. The other eye remained untreated and served as control.

REMOVAL OF TEST SUBSTANCE
- Washing : 24 hours after instillation of the test substance the treated eye was rinsed with saline.

SCORING SYSTEM:
DRAIZE method, and any serious lesions or toxic effects other than ocular irritation, were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

animal: all tested animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: D11 and D8

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: D1

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Irritant

Any other information on results incl. tables

Animal n.	Weight (kg)	Sex	Tissue	Signs	DRAIZE GRADES					irritation index
					1 h	24 h	48 h	72 h	7 d
D1	3.6	♀	Cornea	Opacity	0	1	1	1	0	1.0
				Area	0	2	2	2	0
			Fluorescin	Intensity	-	2	2	1	0
				Area	-	2c	2c	1c	0
			Iris		0	0	0	0	0	0.0
			Conjunctivae	Redness	0	1	2	2	0	1.7
				Swelling	3	2	1	0	0	1.0
			Aqueous	Humor	0	0	0	0	0
				Discharge	2	2	1	0	0
D11	3.7	♀	Cornea	Opacity	0	0	0	0	0	0.0
				Area	0	0	0	0	0
			Fluorescin	Intensity	-	1	0	0	0
				Area	-	2c	0	0	0
			Iris		0	0	0	0	0	0.0
			Conjunctivae	Redness	0	2	2	2	0	2.0
				Swelling	3	3	0	0	0	1.0
			Aqueous	Humor	0	0	0	0	0
				Discharge	2	3	2	0	0
D8	4	♀	Cornea	Opacity	0	1	0	0	0	0.3
				Area	0	2	0	0	0
			Fluorescin	Intensity	-	1	0	0	0
				Area	-	2c	0	0	0
			Iris		0	0	0	0	0	0.0
			Conjunctivae	Redness	0	2	2	2	0	2.0
				Swelling	2	2	0	0	0	0.7
			Aqueous	Humor	0	0	0	0	0
				Discharge	2	1	0	0	0

c = confluent diffuse areas

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritating to eyes) based on CLP criteria

Conclusions:

Irritant

Executive summary:

Method

The substance was tested according to the OECD Guidelines 405 with slight modifications which do not affect the validity of the test. Moreover the test has been conducted in compliance with the GLP Regulation.

Results

The dyestuff showed in the test condition irritating effects fully reversible within 7 days. The conjunctival redness mean scores following grading at 24, 48 and 72 hours, in 2 of 3 tested animals are positive (Conjunctival redness = 2). Therefore the substance is considered as Irritant for eye.