Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]cobaltate(3-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

source of read-across

Adequacy of study:

key study

Study period:

From April 13th to May 1st, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Details on the read-across are available in section 13.

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

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: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf
Number of animals: 2 male, 1 female
Age at start of treatment: male, 15 weeks, females 16 weeks
Body weight at start of or treatment: male 2.7-2.9 kg, females: 2.3 kg
Identification: by unique cage number and corresponding ear tags.
Acclimatization: four days under test conditions after veterinary examination.
Allocation: Animal Numbers, Male no 96-97 Female nos. 98

HUSBANDRY
Room no.: 138
Standard Laboratory Conditions:
Air-onditioned with 10-15 air changes per hour and hourly monitored environment with temperature 20±3 °C, relative humidity 40-70%, 12 hours artificial fluorescent light/12 hours dark, music/light period.
Accommodation: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
Diet: pelleted standard Kliba 341, Batch 52/90 rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
Analysis for contaminants performed.
Water: community tap water from Itingen, ad libitum
Analysis for contaminants performed.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g of test substance

Observation period (in vivo):

Viability, mortality: daily
Body weight: start of acclimatization, day 1 of test (application day) and at termination of observation.
The eye reaction were examined at 1, 24, 48 and 72 hours, 7 and 14 days after administration.

Number of animals or in vitro replicates:

2 males, 1 female

Details on study design:

The eyes of the animals were observed one day prior to test article administration.
On test day 1, 0.1 g or the test article was placed in the conjunctival sac or the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together ror about one second to prevent loss or the test article. The right eye remained untreated and served as the reference control.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide rrom the Consumer Product Safety Commission Washington, D.C. 20207 would be used for additional control purposes.
Eye examinations were made with a slit—lamp 30 SL/M (C. Zeiss AG, Zuerich/Switzerland) and a Varta Cliptrix diagnostic—lamp (A. Riegger, Basel/Switzerland).
The observation was terminated 14 days after administration of the test article.
No necropsy was performed in the animals killed at termination of observation. All rabbits were killed by an intravenous injection of T61 (Hoechst/AG) into the ear vein and discarded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.6

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Irritant / corrosive response data:

No vascularization was observed.
No acute clinical symptoms were observed in the animals during the test period and no mortality occurred.
In the area or application a yellow staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.
Opacity was observed in two animals between 1 hour and 7 days and in one animal between 1 to 72 hours after test article administration.

Other effects:

The body weight gain of all rabbits was similar.
No necropsy was performed. All animals were killed and discarded.

Any other information on results incl. tables

To calculate the irritation effect all scores of each animal at each of the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (Council Directive 83/467/EEC, July 1983 and 67/548/EEC, May 1987, Brussels, Belgium).

Applicant's summary and conclusion

Interpretation of results:

other: classified as irritant within the CLP Regulation (EC 1272/2008)

Conclusions:

Irritant for rabbit eye.

Executive summary:

The substance is tested for eye irritation according to OECD guideline 405.

Observation for effects was done 1, 24, 48 and 72 hours after start of exposure, up to 7 and 14 days. It was terminated after 14 days, because a clear tendency of a healing process was observed.

A yellow staining of the cornea and conjunctivae of treated eyes by pigment or coloring of test article was seen.

If necessary, prior to the first reading of the reactions, the eye was cleaned with disposable tissues to remove staining produced by test substance, so that reactions (erythema) were clearly visible.

Opacity of cornea was observed in two animals between 1 hour and 7 days and in one animal between 1 to 72 hours.

Mean value of the scores for each type of lesion, calculated for each animal separately, is the following:

1 male

Cornea opacity: 2

Iris: 0.67

Conjunctivae redness: 2

Conjuntivae chemosis: 2

1 male

Cornea opacity: 1.67

Iris: 0.67

Conjunctivae redness: 2

Conjuntivae chemosis: 2

1 female

Cornea opacity: 1

Iris: 0

Conjunctivae redness: 2

Conjuntivae chemosis: 1

Based on test results, the substance has to be considered as irritant to eyes.

As treated eyes were not rinsed, effects represent a worst-case situation.