Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate

Cas Number:

84045-65-8

Molecular formula:

C31H21Na3ClN7O10S3

IUPAC Name:

Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Company code: FAT 40'147/E
Batch No.: EN 94'066.32
Purity: 83.3 %
Appearance: powder
Stability of the test compound: until October 1988
pH-value: 7.9 (1g/l water)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
Number and sex of animals used: 3 males
Initial age range: 12 - 14 weeks
Initial body weight range: 2150-2370 G
Individual identification: numbered ear tags. The cages were marked with animal No.and sex, the GU-Project No.and the company code of the test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20±3° C, relative humidity 30-70 %; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food NAFAG No.814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were killed by the intravenous injection of hypnotic T61 (Hoechst).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and served as a control.

Amount / concentration applied:

0.1 g

Observation period (in vivo):

10 days

Number of animals or in vitro replicates:

3 males

Details on study design:

Test Procedure:
0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as the control.

Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. The ocular irritation scores were evaluated.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals
and taking into account the reversibility of the effect.

Symptoms: daily a.m.and p.m. on working days,once daily on weekends and holidays
Body weight: at begin of the acclimatization and at end of test
Mortality: daily a.m.and p.m. on working days,once daily on weekends and holidays

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Due to intensive red staining by the test substance, scoring for corneal opacity was not possible till 72 hours

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Max. score:

3

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Due to intensive red staining by the test substance, scoring for corneal opacity was not possible till 7 days (animal no. 1), 48 hours (animal no. 2) and 72 hours (animal no. 3)

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.8

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

The animals had recovered at the end of the observation period of 10 days.

Other effects:

The animals showed a normal body weight development.

Any other information on results incl. tables

Due to intensive red staining, scoring for corneal opacity and conjunctival redness was not possible at certain observation time points (see remarks in the 'Results of in vivo study' for details).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40147/E can be considered as not an eye irritant.

Executive summary:

The eye irritation potential of the test substance was evaluated in a study conducted according to OECD Guideline 405. The test was performed on 3 male New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the right eye of the rabbits and the lidsthen held together for about one second in order to prevent loss of the test material. The left eye was not treated and served as an untreated control.The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. Due to intensive red staining, scoring for corneal opacity and conjunctival redness was not possible at certain observation time points.

A slight irritation with conjunctival redness and chemosis was observed. The animals were free of findings by the day 10. The mean score for chemosis was calculated to be 1.8, with two animals having a mean score of 1.7 and one animal having a mean score of 2. Hence, the scores do not meet the classification criteria sert forth by CLP (Regulation 1272/2008). Based on the above findings, the test substance FAT 40147/E can be considered as not an eye irritant.