2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: contact test on human skin
- Short description of test conditions: dry, moistened with water and moistened with peanut oil texture samples dyed with the test substance and undyed control samples were fixed on the dorsal skin of 5 male and 5 femal adults on 4 consecutive days for each 8 hours
- Parameters analysed / observed: skin irritation, redness and corrosion

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt

EC Number:

277-179-9

EC Name:

2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt

Cas Number:

72987-16-7

Molecular formula:

C29 H26 F N7 O11 S3 . x K . x Na C29H(26-x-y)FK(x)N7Na(y)O11S3

IUPAC Name:

potassium sodium 2-{[4-({4-[(4-amino-9,10-dioxo-3-sulfonato-9,10-dihydroanthracen-1-yl)amino]cyclohexyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}benzene-1,4-disulfonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

(1) dyed texture (BW Trickot gebleicht) with 3% test item
(2) undyed texture (BW Trikot gebleicht)

Test animals

Species:

other: human

Strain:

other: n/a

Test system

Type of coverage:

other: patch bandage

Preparation of test site:

not specified

Vehicle:

other: non, water, peanut oil

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 * 2 cm sized dyed texture

VEHICLE
- used vehicle for moisture: non, water, peanut oil

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 2 to 2 cm sized undyed texture

Duration of treatment / exposure:

8 hours exposure on 4 consecutive days

Observation period:

Observation directly before and after application and 7 days after last application

Number of animals:

5 male and 5 female persons

Details on study design:

TEST SITE
- Area of exposure: 2 * 2 cm
- Type of wrap if used: patch bandage

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): directly before and after application and 7 days after last application

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

Results 3

Irritation parameter:

other: corrosion

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No signs of irritation related to the substance were observed. The substance is not classifiable according to CLP criteria. Weak irritation signs that were fully reversible within 96 h (water and peanut oil treatment) also occurred in the negative controls and were therefore considered mechanic irritation effects.