Multi constituent substance

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD guideline 405 in compliance to GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Reference 2

Reference Type:

other: Published secondary source

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Multi constituent substance

EC Number:

916-603-5

IUPAC Name:

Multi constituent substance

Details on test material:

Test substance : Basic Red 76 (COLIPA number C008)
Batch number : 0050644101
Methylsulphate anion : 11.8%
Chloride ion : 1.6%
Water : 5.1%
o-Anisidine : 5ppm
Purity : 98.1% (HPLC)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

Each animal was treated by instillation of the test substance in the conjunctival sac of left eye. The substance remained in permanent contact with the eyes until rinsing with warm tap water 24 hours after instillation.

Observation period (in vivo):

All eyes were examined and scored 1, 24, 48, 72 hours and 7 days after instillation of the test substance.

Number of animals or in vitro replicates:

Three

Details on study design:

The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment the test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test item. The right eye remained untreated and served as the reference control. Twenty-four hours after treatment, the treated and untreated eyes were rinsed with lukewarm tap water. The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC at approximately 1, 24, 48 and 72 hours as well as 7 days after instillation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritant / corrosive response data:

The instillation of the undiluted test item into the eyes resulted in mild, early onset and transient ocular changes. Reddening of the conjunctivae and sclerae, discharge and chemosis were observed. These effects were reversible and were no longer evident 72 hours after treatment. No abnormal findings were observed in the cornea and iris of any animal at any of the examinations. No corrosion was observed at any of the inspection times. Slight red staining of the treated eyes by the test item was observed in all animals at the 1 hour and 24 hours inspection times and persisted in two animals up to 48 hours and in one animal up to 72 hours after treatment.

Any other information on results incl. tables

The instillation of the undiluted test item into the eyes resulted in mild, early onset and transient ocular changes. Reddening of the conjunctivae and sclerae, discharge and chemosis were observed. These effects were reversible and were no longer evident 72 hours after treatment. No abnormal findings were observed in the cornea and iris of any animal at any of the examinations. No corrosion was observed at any of the inspection times. Slight red staining of the treated eyes by the test item was observed in all animals at the 1 hour and 24 hours inspection times and persisted in two animals up to 48 hours and in one animal up to 72 hours after treatment.

Eye Irritation Scores - Assessment According To EEC Guidelines

Interval	Cornea Opacity	Iris	Conjunctivae	Chemosis
48 Hours	Not irritating	Not irritating	Not irritating	Not irritating

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to the rabbit eye.

Executive summary:

The primary eye irritation of the test item was investigated according to OECD guideline 405. The test item was applied by instillation of 0.1g 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 24 hours after instillation. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7 days 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 0.0 for all three animals. The individual mean scores for the conjunctivae were 0.0, 0.33 and 0.67 for reddening and for chemosis 0.0 for all three animals. The instillation of the test item 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 72 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. Slight red staining of the treated eyes by the test item was observed in all animals at the 1 and 24 hour reading and persisted in two animals up to 48 hours and in one animal up to 72 hours after treatment. The study was closed 7 days after instillation. No clinical signs were observed. The test item did not induce significant or irreversible damage to the rabbit eye. Based upon the referred classification criteria the test item is considered to be not irritating to the rabbit eye.