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 sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: J.H. DRAIZE et al.; J. Pharmacol. Exp. Therap. 82, 1944,377

Principles of method if other than guideline:

- Principle of test: intracutaneous application of test substance solution on guinea pigs
- Parameters analysed / observed: swelling and reddening

GLP compliance:

yes

Type of study:

intracutaneous test

Justification for non-LLNA method:

Study from 1979, predates LLNA

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

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright White

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Ivanovas (later: Charles River, Kisslegg)
- Weight at study initiation: average 310g
- Housing: 3 animals per cage (Makrolon cage type IV)
- Diet (e.g. ad libitum): Altromin standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2°C

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: 1% Cremophor in distilled water

Concentration / amount:

0.1 %
first treatment: 0.05 mL/animal
following 9 injections: 0.1 mL/animal

Day(s)/duration:

a total of 10 injection, every monday, wednesday, and thursday - for a total of 4 weeks

Challenge

No.:

#1

Route:

intradermal

Vehicle:

other: 1% cremophor

Concentration / amount:

0.1%
11th injection: 0.05 mL/animal

Day(s)/duration:

14 days after last induction treatment = in the 6th week / single injection

No. of animals per dose:

15 animals per dose and 15 animals for control

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Vehicle: 1% Cremophor in distilled water
- Concentration: 0.1 % test item in vehicle
- Exposure period: one injection on Monday, Wednesday and Thursday in 3 consecutive weeks and on Monday of week 4
- Test groups: 1 test group: injection 1: 0.05 ml/animal; injections 2 - 10: 0.1 ml/animal;
- Control group: yes, injection of vehicle without test item in the same amount as test group
- Site: right flank, shaved
- Frequency of applications: one injection on Monday, Wednesday and Thursday in 3 consecutive weeks and on Monday of week 4
- Concentrations: injection 1:0.05 mg test item/animal injection 2 - 10: 0.1 mg test item/animal

B. CHALLENGE EXPOSURE
- No. of exposures: singel injection - injection no 11: 14 days after injection 10
- Vehicle: 1% Cremophor in distilled water
- Concentration: 0.1 % test item in vehicle
- Test groups: injection 11: 0.05 ml/animal
- Control group: yes, injection of vehicle without test item in the same amount as test group
- Site: left flank, shaved
- Concentrations: injection 11: 0.05 mg test item/animal
- Evaluation (hr after challenge): 24 hours after application

- Observation: each 24h after injection, assesment of redness and swelling, weekly weighing

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

15

Clinical observations:

redness and swelling corresponds to control groups

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0%

No. with + reactions:

0

Total no. in group:

15

Any other information on results incl. tables

No effect on body weight gain observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No signs of skin sensitisation were observed. The substance is not classifiable according to CLP criteria.