Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-

Endpoint summary

Description of key information

The test substance has no skin or eye irritating properties

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

The study period covered twelve days. It involved a total of'six applications and six decontaminations. On days 0, 2, 4, 6, 8 and 10 of the test, 0.1 g of the test agent was applied occlusively for 24 hours to the clipped back of each of three female rats. On days 1, 3, 5, 7, 9, and 11 the bandage was removed and the skin of all animals cleaned using 1% cetrimide solution. Daily visual examination was made of each animal to assess irritation.

GLP compliance:

no

Species:

rat

Strain:

other: Alderley Park Albino strain

Details on test animals or test system and environmental conditions:

Initial body weight: 150 g

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

6 x 24 hours

Observation period:

12 days

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: back
- Treatment days: 0, 2, 4, 6, 8 and 10

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 1% cetrimide
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS: daily

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of skin irritation was noted

Other effects:

The skin of all animals was stained blue by the dye.

Interpretation of results:

GHS criteria not met

Conclusions:

No signs of skin irritation was noted

Executive summary:

A test for skin irritation was performed over a period of twelve days. The study design consisted of a total of'six applications and six decontaminations. On days 0, 2, 4, 6, 8 and 10 of the study, 0.1 g of the test substance was applied occlusively for 24 hours to the clipped back of each of three female rats. On days 1, 3, 5, 7, 9, and 11 the bandage was removed and the skin of all animals cleaned using 1% cetrimide solution. Daily visual examination was made of each animal to assess irritation. There were no signs of skin irritation noted. The skin of all animals showed blue staining.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Zeneca
- Weight at study initiation: 2.5 to 3.5 Kg

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

1 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: -

SCORING SYSTEM: Draize (1959) scale; a modified version of the system devised by Kay and Calandra (1962) was used for interpretation and classification of the numerical scores; an estimate of the pain produced at the time of application was made using a 6-point scale.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight initial pain was observed after instillation of the test substance. Slight redness of the conjunctiva and some mucopurulent discharge was observed within the first 24 hours after test substance application. All effects were reversed after 48 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not an irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No signs of skin and eye irritation occurred. Therefore, no classification applies.