Hydrogen 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 28, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

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), with slight modification.

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Orange 060 - Similar Substance 01

IUPAC Name:

Acid Orange 060 - Similar Substance 01

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: average body weights of 2.73 kg (males) and 2.38 kg (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet (e.g. ad libitum):A commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water (e.g. ad libitum):Sterile filtered water was available at all times.
- Acclimation period: Six rabbits were acclimatised in the test area for one week prior to the start of the trial

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:

other: The right eye served as a control

Amount / concentration applied:

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

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

Six rabbits (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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.

SCORING SYSTEM: the ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redeness

Basis:

animal: 15

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: washed eyes

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: 14, 16

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: washed eyes

Results 3

Irritation parameter:

chemosis score

Basis:

animal: 14, 15, 16

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no symptoms

Remarks on result:

other: washed eyes

Irritant / corrosive response data:

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 40 hours.

Other effects:

None

Any other information on results incl. tables

Rabbit eye irritation scores-reference procedure:

		1 hour							6 hours							1 Day							2 Days							3 Days							6 Days
	Rabbit No	11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16
	Conjuctivae
A	Redness	2	2	2	2	1	1		-	-	-	-	-	-		1	2	1	2	1	1		1	1	-	1	1	1		-	1	-	-	-	-		-	-	-	-	-	-
B	Chemosis	2	2	1	2	1	2		-	-	-	-	-	-		1	1	-	1	-	-		1	1	-	1	-	-		-	-	-	-	-	-		-	-	-	-	-	-
C	Discharge	2	1	-	3	-	-		-	-	-	-	-	-		-	-	-	-	-	-		-	-	-	-	-	-		-	-	-	-	-	-		-	-	-	-	-	-
c=(A+B+C) X2	(max. 20)	12	10	6	14	4	6		-	-	-	-	-	-		4	6	2	6	2	2		4	4	-	4	2	2		-	2	-	-	-	-		-	-	-	-	-	-
Total	(Max.110)	12	10	6	14	4	6		-	-	-	-	-	-		4	6	2	6	2	2		4	4	-	4	2	2		-	2	-	-	-	-		-	-	-	-	-	-

Eyes washed in Nos. 14, 15 & 16 hours

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not irritant

Executive summary:

Method

The study was performed to determine the eye irriattion potential of the test substance in rabbits according to the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.

Conclusion

Not irritant