.beta.-Alanine, N-[2-chloro-4-[2-(4-nitrophenyl)diazenyl]phenyl]-, 2-[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]-2-oxoethyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 27 to March 9, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Yellow 981

IUPAC Name:

Yellow 981

Test material form:

solid: particulate/powder

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 to the conjunctival sac of the left eye of each animal

Duration of treatment / exposure:

no rinse

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

- Observations: mortality (daily), clinical signs (daily), body weights (start and end of study period), corneal opacity (1, 24, 48, 72 h; max: 4), iritis (1, 24, 48, 72 h: max: 2), conjunctival redness (1, 24, 48, 72 h, max: 3), conjunctival chemosis (1, 24, 48, 72 h; max: 4)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No abnormal findings were noted in the cornea or iris at any reading, in any animal.
Slight to moderate reddening of the conjunctivae was observed in all animals from 1 to 24 hours after treatment and persisted in one female up to the 48-hour reading.
Slight-to-obvious swelling of the conjunctivae (with partial eversion of lids) was noted in all animals 1 hour after treatment.
Slight swelling was still evident in both females at the 24-hour reading.
Slight-to-moderate reddening of the sclera was observed in all animals 1 hour after treatment.
Slight reddening persisted in two animals up to the 24-hour reading and in the other animal up to the 48-hour reading.
A slight watery discharge was noted in all animals 1 hour after treatment.
All eye reactions had cleared within 72 hours of treatment.

Other effects:

No mortality or clinical signs were observed in any animal at any time point, up to sacrifice, with the exception of colouration from the test item.
A light orange coloration of the eye was evident in all animals at the 1-hour reading. Orange remnants of the test item were evident in the eye or conjunctival sac of all animals 1 hour after treatment, and persisted in one female up to the 24-hour reading.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Very slightly irritating to the rabbit eye.