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)-

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Materials and methods

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

Test material

Test material information

Constituent 1

Reference substance name:

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)-

EC Number:

268-655-7

EC Name:

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)-

Cas Number:

68132-91-2

Molecular formula:

C38H20Cl2CuN14O18S5. H. 5Na C38H21Cl2CuN14Na5O18S5

IUPAC Name:

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)-

Test material form:

solid: particulate/powder

Details on test material:

Test Substance : Procion Blue H-E RD = Reactive Blue 160

Test animals

Species:

rat

Strain:

other: Alderley Park Albino strain

Details on test animals or test system and environmental conditions:

Initial body weight: 150 g

Test system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

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.

Applicant's summary and conclusion

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.