2-[(2-cyanoethyl)[4-[(6-nitrobenzothiazol-2-yl)azo]phenyl]amino]ethyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

According to The Code of Federal regulations, title 16, section 1500.42.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Red 177

IUPAC Name:

Disperse Red 177

Test animals / tissue source

Species:

rabbit

Test system

Vehicle:

physiological saline

Controls:

yes

Amount / concentration applied:

59 mg

Observation period (in vivo):

24, 48, 72 h and 7 d

Number of animals or in vitro replicates:

6

Details on study design:

Ocular reactions were scored by the method described by J-H. Draize in "Appraisal of the safety of chemicals in foods, drugs and cosmetics" p51, 1959.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 3 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal: #4 and #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 11

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Irritant / corrosive response data:

Temporary corneal opacities developed in three animals and a temporary dulling of the normal lustre of the cornea was observed in one other animal. A small ulcerated area was observed on the cornea of the latter. This had resolved by day 7.
A diffuse crimson-red colouration of the coniunctivae accompanied by slight to considerable swelling with partial eversion of the eyelids or with the eyes about half closed was observed in four animals. Some slight haemorrhagic lesions were observed in the coniunctivae of animal number 6 on day 3.
Mild conjunctival reactions were seen in the two remaining animals.

Any other information on results incl. tables

Numerical scores associated to ocular reactions

animal no.	region of eye	day
		1	2	3	7
1	cornea	0	D	D	0
	iris	0	0	0	0
	conjunctivae redness	2	2	2	1
	conjunctivae chemosis	3	2	2	1
2	cornea	0	0	0	0
	iris	0	0	0	0
	conjunctivae redness	1	2	1	1
	conjunctivae chemosis	2	2	1	0
3	cornea	1	D	0	0
	iris	0	0	0	0
	conjunctivae redness	1	1	1	0
	conjunctivae chemosis	1	1	0	0
4	cornea	D	1	D	0
	iris	0	0	0	0
	conjunctivae redness	1	0	0	0
	conjunctivae chemosis	1	1	1	0
5	cornea	D	1	D	0
	iris	0	0	0	0
	conjunctivae redness	1	1	2	0
	conjunctivae chemosis	1	1	1	0
6	cornea	0	0	0	0
	iris	0	0	0	0
	conjunctivae redness	2	2	2	1
	conjunctivae chemosis	2	2	1	1

D = dulling of the cornea

Applicant's summary and conclusion

Interpretation of results:

other: not irritant according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not irritant to rabbit eye.

Executive summary:

Method

Study conducted according to The Code of Federal Regulations, title 16, section 1500.42. Accordingly, 59 mg of test substance was instilled into one eye of 6 rabbits, while the untreated eye remained as control. Ocular reactions on cornea, iris and conjunctivae were scored according to Draize, after 24, 48, 72 h and 7 d. No rinse was done.

Results

No effects on iris were noted; cornea opacity and dulling was noted in 5/6 rabbits and such effect was fully reversible within 7 days.

Conjunctivae redness and chemosis were noted in 6/6 rabbits and scored less than 2 over the 24/48/72 h observation period, except for 2/6 and 1/6 rabbits, respectively. Even in case such effect did not disappear by the end of the observation period (7 days), a clear tendency to decrease was evident.

On these bases, test substance was considered as not irritant to rabbit eye.