Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate

Eye irritation

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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:

guideline study

Remarks:

well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

84/449/EEC

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: bulk

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG breeding colony
- Age at study initiation: 3 months to 5 months
- Weight at study initiation: 2.3 kg to 2.6 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) and appr. 15 g hay daily, ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of each treated animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

Single instillation, exposure period: 24 hours (washing 24 h after instillation)

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3

Details on study design:

Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
The eyes were examined 1, 24, 48 and 72 hours after application of the test item

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light (24 and 72 hour readings)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since on effects occured

Results 2

Irritation parameter:

iris score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: 1 hour after application inflammation grade 1 was observed in all animals, which was fully reversible after 24 h.

Results 3

Irritation parameter:

chemosis score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: 1 hour after application grade 1 and 2 chemosis was observed in all animals, which was fully reversible within 24 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: 1 hour after application grade 2 conjunctival redness was observed in all animals, which was fully reversible for animal #2 within 24 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: # 1, 3 each

Time point:

other: mean of 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: 1 hour after application grade 2 conjunctival redness was observed in all animals, which was fully reversible for animals #1 and #3 within 48 h

Irritant / corrosive response data:

1 hour after application the treated eyes of all animals exhibited a slight injection of conjunctival blood vessels up to a diffuse, beefy red colour as well as slight swellings. the iris of all animals was reddened. Additionally yellow discharge was noted.

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

All recorded ocular reactions were fully reversible within 48 h an all mean scores were well below the threshold values for classification. Therefore, the test item has not to be classified as irritation to the eyes according to Regulation (EC) No 1272/2008.

Executive summary:

A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.

1 hour after application the treated eyes of all animals exhibited a slight injection of conjunctival blood vessels up to a diffuse, beefy red colour as well as slight swellings and the iris of all animals was reddened. Additionally yellow discharge was noted. But mean scores (mean of 24, 48, and 72 h) of all animals were well below the threshold values for classification. 48 hours after treatment all signs of irritation were fully reversible.

Therefore, the test item has not to be classified as irritation to the eyes according to Regulation (EC) No 1272/2008.