2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to OECD TG 405 and in accordance with the Principles of Good Laboratory Practice (GLP)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

EC Number:

296-120-8

EC Name:

2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

Cas Number:

92257-31-3

Molecular formula:

Not applicable

IUPAC Name:

2-​Naphthalenol, 1-​[2-​[4-​(2-​phenyldiazenyl)​phenyl]​diazenyl]​-​, ar-​heptyl ar',​ar''-​Me derivatives *

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test Animals:
-Source: New York State Rabbit Development, Hartwick, N.Y.
-Weight at study initiation: Approximately 2-4kg
-Housing: Individually housed in wire mesh bottom cages
-Food: NIH Animal feed A, ad libitum
-Water: Tap water, ad libitum
-Acclimation period: minimum of 5 days

Environmental Conditions
-Temperature (C): as per "Guide for the Care and Use of Laboratory Animals"
-Humidity (%): as per "Guide for the Care and Use of Laboratory Animals"
-Air Changes (per hr): 12-15 air changes/hour
-Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye for each animal served as untreated control.

Amount / concentration applied:

A volume of 0.1 ml instilled in the everted lower lid of one eye of each animal. The other eye served as the untreated control.

Duration of treatment / exposure:

The lids of the treated eyes of the animals were held closed for one second following instillation and were not irrigated. The animal was then returned to it's cage.

Observation period (in vivo):

Observations for eye irritation were made at 1, 24, 48, and 72 hours and again at 7 days after application of the test article.

Number of animals or in vitro replicates:

6

Details on study design:

Method:
Animals wiil be weighed and weights recorded prior to the initiation of the study.
Approximately 24 hours prior to test initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only those
rabbits whose eyes were free of irritation and corneal lesions were used.
A volume of 0.1 ml was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. The lids were then held together for one second after which the animal was returned to its cage. The treated eyes were not irrigated.
With the untreated eye serving as a control, the eyes were examined using fluorescein dye procedures and the grade of ocular reaction for each animal was recorded at 1, 24, 48 and 72 hours and again at 7 days using the Draize Scale for Scoring Ocular Lesions. If injury persisted the eyes were further examined and scored every 3 days for 13 days or until all signs of reversible irritation subsided.

Test Article Classification:
The mean eye irritation score and the standard deviation of the mean were determined for each observation period. The greatest mean score observed was used to assign the test article an ocular irritation rating in accordance with the classification system of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: Mean score for all animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

other: Mean score for all animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: Mean score for all animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

other: Mean score for all animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

See results section.

Any other information on results incl. tables

Individual Rabbit Eye Irritation Scores

			Reading
Rabbit Number	Item	Tissue	1 hr	24 hr	48 hr	72 hr	Day 7
0906NW	A	Cornea Opacity	0	0	0	0	0
	B	Cornea Area	0	0	0	0	0
	(1)	Cornea Total=(AxB)x5	0	0	0	0	0
	C	Iris	0	0	0	0	0
	(2)	Iris Total=(C)x5	0	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0	0
	(3)	Conjunctiva Total (D+E+F)x2	0	0	0	0	0
		Totals Added= (1+2+3)	0	0	0	0	0
0874NW	A	Cornea Opacity	0	0	0	0	0
	B	Cornea Area	0	0	0	0	0
	(1)	Cornea Total=(AxB)x5	0	0	0	0	0
	C	Iris	0	0	0	0	0
	(2)	Iris Total=(C)x5	0	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0	0
	(3)	Conjunctiva Total (D+E+F)x2	0	0	0	0	0
		Totals Added= (1+2+3)	0	0	0	0	0
0875NW	A	Cornea Opacity	0	0	0	0	0
	B	Cornea Area	0	0	0	0	0
	(1)	Cornea Total=(AxB)x5	0	0	0	0	0
	C	Iris	0	0	0	0	0
	(2)	Iris Total=(C)x5	0	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0	0
	(3)	Conjunctiva Total (D+E+F)x2	0	0	0	0	0
		Totals Added= (1+2+3)	0	0	0	0	0
0877NW	A	Cornea Opacity	0	0	0	0	0
	B	Cornea Area	0	0	0	0	0
	(1)	Cornea Total=(AxB)x5	0	0	0	0	0
	C	Iris	0	0	0	0	0
	(2)	Iris Total=(C)x5	0	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0	0
	(3)	Conjunctiva Total (D+E+F)x2	0	0	0	0	0
		Totals Added= (1+2+3)	0	0	0	0	0
0878NW	A	Cornea Opacity	0	0	0	0	0
	B	Cornea Area	0	0	0	0	0
	(1)	Cornea Total=(AxB)x5	0	0	0	0	0
	C	Iris	0	0	0	0	0
	(2)	Iris Total=(C)x5	0	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0	0
	(3)	Conjunctiva Total (D+E+F)x2	0	0	0	0	0
		Totals Added= (1+2+3)	0	0	0	0	0
0799NW	A	Cornea Opacity	0	0	0	0	0
	B	Cornea Area	0	0	0	0	0
	(1)	Cornea Total=(AxB)x5	0	0	0	0	0
	C	Iris	0	0	0	0	0
	(2)	Iris Total=(C)x5	0	0	0	0	0
	D	Conjunctiva Redness	0	0	0	0	0
	E	Conjunctiva Chemosis	0	0	0	0	0
	F	Conjunctiva Discharge	0	0	0	0	0
	(3)	Conjunctiva Total (D+E+F)x2	0	0	0	0	0
		Totals Added= (1+2+3)	0	0	0	0	0

 

Initial Body Weights:

Animal Number              Initial Body Weight (kg)

82 -0906 M                            2.70

82 -0874 M                            2.85

82 -0875 M                            2.87

82 -0877 M                            2.83

82 -0878 M                            2.94

82 -0799 M                            2.75

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material is not considered corrosive to the eyes of rabbits.

Executive summary:

The eye irritation potential of the test material was evaluated in 6 New Zealand White rabbits. Animal body weights were recorded prior to the initiation of the study. Approximately 24 hours prior to test initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only those rabbits whose eyes were free of irritation and corneal lesions were used. A volume of 0.1 ml was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. The lids were then held together for one second after which the animal was returned to its cage. The treated eyes were not irrigated. With the untreated eye serving as a control, the eyes were examined using fluorescein dye procedures and the grade of ocular reaction for each animal was recorded at 1, 24, 48 and 72 hours and again at 7 days using the Draize Scale for Scoring Ocular Lesions. Under the conditions of the study, The test material is not considered corrosive to the eyes of rabbits.