Trisodium bis[3-[[1-(anilinocarbonyl)-2-oxopropyl]azo]-5-chloro-2-hydroxybenzenesulphonato(3-)]cobaltate(3-)

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:

October 3, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 204 - Similar Substance 01

IUPAC Name:

Acid Yellow 204 - 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:

- Source: IVANOVAS
- Weight at study initiation: 2-3 kg
- Housing:individually in metal cages
- Diet: rabbit food - NAFAG, No. 814, Gossau SG ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 50 ± 10 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline

Duration of treatment / exposure:

After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline

Observation period (in vivo):

The rabbits were examined 1, 24, 48, 72 hours and 7 days

Number of animals or in vitro replicates:

The test was performed on 3 male and 3 female adult rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: yes

TOOL USED TO ASSESS SCORE:
The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 167, 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: 167, 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 167

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal: 167, 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Non irritant

Executive summary:

The substance has been tested for eye irritation according to (EPA) § 163.81-4 "Primary eye irritation study". According to the Regulation EC n. 1272/2008 the test material was found to cause no irritation when applied to the rabbit eye mucosa.