1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol

EC Number:

220-562-2

EC Name:

1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol

Cas Number:

2814-77-9

Molecular formula:

C16H10ClN3O3

IUPAC Name:

1-[(2-chloro-4-nitrophenyl)diazenyl]-2-naphthol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), C. I Pigment Red 4 is considered to be “not irritating” to the rabbit eye

Executive summary:

The primary eye irritation potential of Hansa Rot R was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours 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 and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.00 and 0.33 for reddening, respectively, and 0.00 for chemosis for all the three animals. The instillation of Hansa Rot R into the eye resulted in mild, 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 48 hours after. Very slight corneal opacity affecting the whole area was noted in one animal 1 hour after the instillation. This finding, however, was considered to be caused by the staining produced by the test item and was no longer evident at the 24-hour reading. A slight red staining was observed in all three animals 1 hour after the application and persisted in two animals up to the 24-hour reading. No corrosion was observed at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. .