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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 April 1992 to 01 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 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

-Batch No.: HT 3728/TV 1
- Purity: 60-70%
- Physical properties: Powder, dark red
- Storage conditions: Room temperature, kkp dark
- Validity: May 15, 1997
- Safety precautions: Gloves and face masks
- Test material received: June 5, 1992

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:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein/ Swizerland
- Age at study initiation: Young adult rats
- Weight at study initiation: 210 - 265 g
- Housing: test animals were housed in Macrolon cages type 3, with standardized soft wood bedding.
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours/day light cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: Back of rat
- % coverage: 10 %
- Type of wrap if used: Adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

10 test animals (5 males and 5 females)

Control animals:

no

Details on study design:

Approximately 24 hours before treatment an area on the back of the rat of at least 10 % of the body surface was shaved with an electric clipper. The test article was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. All animals found spontaneously dead or been sacrificed (either for humane reasons or at the termination of the study) were subjected to a complete necropsy.

Administration of the test article: one single dose
Dose level: 2000 mg/kg (males and females)
Total number of test animals: 10
Vehicle: distilled water
Volume applied: 4 ml/kg body weight
Observation period: 14 days

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. At the application site, erythema was observed until day 7 in the males and day 9 in the females. The females developed necrosis. The animals recovered within 10 days

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 45155/B in rats after dermal application was greater than 2000 mg/kg.

Executive summary:

A GLP-compliant acute dermal toxicity study in Tif RAI f rats (5/sex) was carried out with FAT 45155/B and observed for a 14-day post-treatment observation period. The study was carried out according to OECD guideline 402. There was no mortality observed during the study. Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. At the application site, erythema was observed until day 7 in the males and day 9 in the females. The females developed necrosis. The animals recovered within 10 days. The test article adhered to the skin until day 5 in males and day 6 in females. At necropsy, no deviations from normal morphology were found. Based on the study results, the median lethal dose (LD50) of FAT 45155/B in rats after dermal application was greater than 2000 mg/kg.