1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Points 8.1 and 8.2 of Annex VIII of REACH have been amendeded. 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

Study period:

From the 25th of November to the 13th of December, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to internationally accepted guideline.

Justification for type of information:

.Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1989

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

1

Reference substance name:

Similar substance 01 of Acid Brown 147

IUPAC Name:

Similar substance 01 of Acid Brown 147

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 malel, 1 female
Age at start of treatment: male, 14 weeks, females 15 weeks
Body weight at start of or treatment: male 2.3-2.6 kg, females: 2.5 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 the test article

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

The eyes of each animal were examined 1, 24, 48 and 72 hours, 7 days and 14 days after administration.
Viability, mortality: daily
Clinical Symptoms daily
Body weight: day 1 of test (application day) and at termination of test on a Mettler PK 16 balanceThe 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.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 theeyeball. 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 Sarety 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.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:

1

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

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:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

3.33

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 days

Score:

1.33

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 14 days

Score:

0

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 10

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 11

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 12

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 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: not rinsed

Irritant / corrosive response data:

The substance showed a primary irritation score of 4.42 when applied to the rabbit eye mucosa.A brown to slight brown staining or the cornea, conjunctivae and eyelashes of the treated eyes by pigment or coloring of the test article was observedCorneal opacity was observed in all animals. Two animals within 1 to 72 hours and one animal within 1 hour to 7 days.

Other effects:

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.With the exception of animal no. 44 the body weight gain of the rabbits was similar. Due to minimal food consumption between days 6 and 15 of test animal.No necropsy was performed. All animals were killed and discarded.no. 44 lost weight. In addition to the laboratory diet (Kliba) hay was red starting with day.

Any other information on results incl. tables

Data are summarized in tabular form, showing for each individual animal the irritation scores at the designated observation time, a description of the degree and nature of irritation, the presence or serious lesions and non-ocular effects.

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:

irritating

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

Irritating for the rabbit eye

Executive summary:

Method

The eye irritation /corrosion property was tested according to the OECD Guideline 405 (Acute Eye Irritation/Corrosion) and the EU Method B.5 (Acute Toxicity: Eye Irritation/Corrosion), in GLP.

Observations

Under the conditions of this experiment, the substance was found to cause a primary irritation score of 4.42 when applied to the rabbit eye mucosa. A brown to slight brown staining of the cornea, conjunctivae and eyelashes of the treated eyes by pigment or coloring of the test article was observed. Corneal opacity was observed in a and one animal within 1 hour to 7 days.

Results

According to EEC Council Directive, 83/467/EEC, July 1983 Brussels, Belgium, the mean value of the scores for each type of lesion are evaluated.

Due to the results the test article had to be classified as irritating to the eyes, also if no rinsing of the eye has been applied.