Sodium bis[N-[7-hydroxy-8-[[2-hydroxy-5-[(methylamino)sulphonyl]phenyl]azo]-1-naphthyl]acetamidato(2-)]chromate(1-)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

LLNA method was not available at the time of testing

Test material

Test material information

Constituent 1

Reference substance name:

Ostalanova sed BL

IUPAC Name:

Ostalanova sed BL

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

non pregnant and nulliparous
At delivery, the veterinary certificate guaranteeing the declared medical condition of experimental animals are carriers of the parasite pathogenic microorganisms viruses and fungi

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

petrolatum

Induction 2

Concentration / amount:

0.5% in water pro injection

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

0.5% in water pro injection

Details on study design:

RANGE FINDING TESTS: Animals were exposed to patch test substances at 25% in petroleum, 5%, % and 0,5% in water pro injection on the side with for 24 hours. 1 h after removal of dressing the local irritation was assessed. The results show that a concentration more than 0.5% of Ostolanova sed BL in water for injection is skin irritating to guinea pigs.


MAIN STUDY
A. INDUCTION EXPOSURE intradermal
- No. of exposures: 2 replicate for each injection
- Test groups: 20 females
- Control group: 10 females
- Site: neck
- Concentrations:
injection #1 test group: Freund's complete adjuvant
injection #2 test group: 0.5% ostalanova sed in water for injection
injection #3 test group: 0.5% ostalanova sed in complete Freund's adjuvant
injection #1 control group: Freund's complete adjuvant
injection #2 control group: water for injection
injection #3 control group: 50% Freund's complete adjuvant + 50% water for injection

INDUCTION EXPOSURE PATCH
- Day of exposure: 7th day
- Exposure period: 48h
- Site: neck, identical position of the intradermal application
- Concentrations:
test group: 2x4 cm of filter paper nrushed with 25% Ostalanovou BLm in white petroleum in occlusive dressing
control group: 2x4 cm of filter paper of white petroleum in occlusive dressing

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 20th and 27th day
- Exposure period: 72h
- Test groups: 2x2 cm impregnated of test substance with occlusive dressing
- Site: right flank for exposure 1 and left flank for exposure 2
- Concentrations: 0.5% Ostolanova BL in water
- Evaluation (hr after challenge): 24h
-the site of application was washed with water

OTHER:

Challenge controls:

The same conditions as the experimental group

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 3

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 4

Reading:

rechallenge

Hours after challenge:

24

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 5

Reading:

rechallenge

Hours after challenge:

24

Group:

positive control

Dose level:

n.a.

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The sample was tested for skin sensitization potential following OECD 406. Albino guinea-pigs were used as the experimental animals. The test results show that the test substance for guinea pigs, is not a skin contact allergen.

Executive summary:

The sample was tested for skin sensitization potential following OECD 406. Albino guinea-pigs were used as the experimental animals. An intradermal and patch induction were used, and the susbtance was challenged at 20th and rechallnged at 27h day of exposure. The substance was tested at a concentration of 0.5% in water pro-injection with an occlusive dressing and dermal reaction were evaluated after 24h after its removal and after 72h of expoure.

There were no positive skin reactions at the first or repeated induced hypersensitive response. There was no difference in the growth and development of animals between experimental and control groups.

No animal showed any allergenic skin reaction and the substance is not considered as a skin contact allergen.