A mixture of: sodium/potassium 7-[[[3-[[4-((2-hydroxy-naphthyl)azo)phenyl]azo]phenyl]sulfonyl]amino]-naphthalene-1,3-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 July 1992 to 29 September 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

code number: FAT 45155/B
batch No.: HT 3728/ TV 1
physical appearance: powder, dark red
storage: room temperature, keep dark
expiration date: May. 15, 1997
safety precautions: gloves and face masks

Specific details on test material used for the study:

Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are 3 females.
TEST ANIMALS
- breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- acclimatisation period: at lease 5 days
- Weight at study initiation: 2540-2670 g
- Housing: individually in metal cages
- Feed: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): a 12 hrs light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

distilled water

Controls:

other: a control gauze patch was applied to the contralated flank

Amount / concentration applied:

0.5 g of the test article was applied to the right flank of the shaved area. It was covered with a 12-16 cm² gauze patch. The gauze was covered with aluminium foil and held in place for 4 hours by an adhesive tape.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 females

Details on study design:

An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (approx. 3 6 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

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

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The application area was red-stained up to the reading of 24 hours animals No. 420 and 408 and up to the reading of 48 hours in animal No. 534. Therefore the evaluation of a possible slight erythema formation was impeded for animal No. 534. The mean values of the recordings 48 to 72 hours after application taken for animals No. 420 and 408 are score zero.

Other effects:

No edema formation was observed during an observation period of 7 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 45155/B was found to cause no irritation when applied to intact rabbit skin.

Executive summary:

A GLP-compliant study was performed to access the primary skin irritation potential when single doses of FAT 45155/B are placed on the skin of New Zealand White rabbits. The study was carried out according to OECD guideline 404. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (approx. 3 6 cm²) and held in place for 4 hours by an adhesive tape. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches. No edema formation was observed during an observation period of 7 days. The application area was red stained up to the reading of 24 hours animals No. 420 and 408 and up to the reading of 48 hours in animal No. 534. Therefore, the evaluation of a possible slight erythema formation was impeded for animal No. 534. The mean values of the recordings 48 to 72 hours after application taken for animals No. 420 and 408 are score zero. Based on the study results, FAT 45155/B can be classified as non-irritant to rabbit skin.