Sodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 25, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)

Deviations:

yes

Remarks:

no data

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 1

IUPAC Name:

Similar substance 1

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Porton
- Age at study initiation: aged 10-13 weeks
- Weight at study initiation: 2.73 Kgs (♂), 2.38 kgs (♀)
- Housing: caged singly, bred on the premises and maintained under a semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water ad libitum.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

single injection

Observation period (in vivo):

The rabbits were examined 1, 24, 48, 72 hours and 6 days after application

Number of animals or in vitro replicates:

Six rabbits (3 ♂ and 3 ♀)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):yes, after 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
- Time after start of exposure: 30 seconds

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal: 11

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal: 12

Time point:

other: 24, 48, 72 hours

Score:

ca. 1

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 13

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 14

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 15

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.33

Max. score:

3

Reversibility:

fully reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

3

Reversibility:

fully reversible

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

11, 12, 13

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

14, 15, 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

According to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The substance is not irritating for rabbit eye.

Executive summary:

The substance has been tested for eye irritation according to The guideline "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965). Six rabbits (3 males and 3 females) were acclimatised in the test area for one week prior to the start of the trial. The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. 100 mg. of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held

closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was

considered necessary.

A slight to moderate conjunctival reaction was seen in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours and thereafter continued to do so until all eyes were normal by 48 hours (1/3 washed) 72 hours (2/3 unwashed 2/3 washed) and 6 days (1/3 unwashed). Staining of the conjunctivae and cornea by the compound was seen in the unwashed eyes for up to 48 hours. The substance is not irritating according to the CLP Regulation (EC n. 1272/2008).