[8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Data is from opinions on health and safety risks (chemical, biological, mechanical and other physical risks)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

[8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride

EC Number:

247-640-9

EC Name:

[8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride

Cas Number:

26381-41-9

Molecular formula:

C19H21N4O.Cl

IUPAC Name:

8-[(4-aminophenyl)diazenyl]-7-hydroxy-N,N,N-trimethylnaphthalen-2-aminium chloride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Basic Brown 16- Molecular formula (if other than submission substance): C19-H21-N4-O.Cl - Molecular weight (if other than submission substance): 356.855- Smiles notation (if other than submission substance): c1(\N=N\c2ccc(cc2)N)c2cc([N+](C)(C)C)ccc2ccc1O.[ClH-]- Substance type: Organic - Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Age at study initiation:young adult

Test system

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3 (1 male and 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing (if done):By lukewarm tap water- Time after start of exposure:48 hoursSCORING SYSTEM:corneal opacity, iris, redness and chemosis of the conjunctivae.TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 14 days

Reversibility:

not reversible

Remarks on result:

other: mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 14 days after treatment

Irritant / corrosive response data:

Slight opacity of the cornea, affecting the whole area, was noted in all animals at the 1- and 24-hour reading due to staining produced by the test item. Slight opacity of the cornea, affecting the whole area, was again visible in one animal 72 hours after treatment.

Any other information on results incl. tables

Score of Irritation parameter
	24 hrs	48 hrs	72hrs
corneal opacity	0.33	0.67	0.33
iris	0.00	0.00	0.00
conjunctivae	1.67	2.00	2.00
redness	1.67	1.33	0.00
chemosis	1.67	0.00	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the study considered Basic Brown 16 to be not irritating to rabbit eye.

Executive summary:

The test substance was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. The treated and untreated eyes were rinsed with lukewarm tap water 48 hours after instillation. Scoring of irritation effects was performed

approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 after test item instillation.The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.

The individual mean scores for corneal opacity were 0.33, 0.67 and 0.33, respectively. The individual mean scores for the iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.67, 2.00 and 2.00 for reddening and 1.67, 1.33 and 1.67 for chemosis, respectively.The instillation of Basic Brown 16 into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis.These effects were reversible and were no longer evident 14 days after treatment, the end of the observation period for all animals. Slight opacity of the cornea, affecting the whole area, was noted in all animals at the 1- and 24-hour reading due to staining produced by the test item. Slight opacity of the cornea, affecting the whole area, was again visible in one animal 72 hours after treatment. No abnormal findings were observed in the iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. Brown staining of the treated eyes produced by the test item was observed in all animals 1 and 24 hours after treatment. No clinical signs were observed.Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Thus from overall observation of experiment the test substance Basic Brown 16 was observed to be not irritating to rabbit eye.