trisodium bis[3-[1-(3-chlorophenyl)-5-(hydroxykO)-3-methyl-1H-pyrazol-4-yl]diazenyl}-4-(hydroxy-kO)5-nitrobenzenesulfonato(3-)]chromate(3-)

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Red 423

IUPAC Name:

Acid Red 423

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:

Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye serves as control

Amount / concentration applied:

0.1 g of the test substance

Duration of treatment / exposure:

eye lids close for 1 seconds

Observation period (in vivo):

up to 7 days

Number of animals or in vitro replicates:

3 males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

24-72 hours all animals

Time point:

other: 24-72 hours

Score:

1.33

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

1

Reversibility:

not reversible

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24-72 hours

Score:

2

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

1.33

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

The tested substance ahowed a primary irritation score of:
1.33 for cornea
1 for iris
2 for conjunctivae redness
1.33 for conjunctivae chemosis
when applied to the rabbit eye mucosa.
The effect was not reversible in 21 days except for chemosis which is fully reversible within 14 days.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

OECD GHS

Conclusions:

The tested substance needs to be considered irritant for rabbits eyes under Regulation CE 1272/2008.

Executive summary:

The ocular reactions were determined followign OECD 405.

The tested substance is considered to be irritant for the rabbits eyes based on the results needs to be classified as H319, Causes serious eye irritation under Regulation 1272/2008.