Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

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:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

FAT 20033/L TE

IUPAC Name:

FAT 20033/L TE

Constituent 2

Reference substance name:

Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate

EC Number:

247-269-2

EC Name:

Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate

Cas Number:

25797-81-3

Molecular formula:

C24H23N3O8S2.Na

IUPAC Name:

sodium 1-amino-4-({3-[(2-hydroxyethyl)sulfamoyl]-4,5-dimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

powder / dark blue

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E0T425-11 (OCT No. 70083)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, Pennsylvania
- Weight at study initiation: 1.6 - 2.4 kg
- Housing: in accordance with standard laboratory procedures
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:

occlusive

Details on dermal exposure:

TEST SITE
- Area of exposure: Back side
- % coverage: 30%
- Type of wrap if used: elastic sleeve

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3g/kg

Duration of exposure:

24 h

Doses:

3 g/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Twenty-four hours prior to dosing, the animals were immobilized in an animal holder and their backs clipped free of hair with an Oster animal clipper, exposing approximately 30 % of each animal's skin surface. Immediately prior to dosing, one-half of the animals were further prepared by making epidermal abrasions longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The test material was applied, in the quantity of 3 g/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. The animals were then returned to their individual cages and observed for toxic signs and survival.

OBSERVATIONS:
The animals were observed daily for adverse reaction and survival for a period of 14 days. In addition, local skin reactions were evaluated at 1, 7 and 14 days. Body weights were recorded prior to dosing and at days 7 and 14. Gross necropsies are performed on all animals.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen throughout the observation period.

Gross pathology:

All gross necropsies were within normal limits.

Other findings:

Edema and erythema were present on all sites for 72 hours and on five sites for four days. The remaining site, at this time, displayed erythema. On the fifth day of scoring, four animals demonstrated erythema and two demonstrated both edema and erythema. On days six, seven and eight, irritation grading showed three animals displaying erythema. After this time, all animals returned to normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of FAT 20033/D in New Zealand albino rabbits is >3 g/kg bw.

Executive summary:

A study was conducted to assess the acute dermal toxicity of FAT 20033/D in New Zealand albino rabbits. A group of 6 animals (3/sex/dose) were used for the study. Twenty-four hours prior to dosing, the animals were immobilized in an animal holder and their backs clipped free of hair with an Oster animal clipper, exposing approximately 30% of each animal's skin surface. Immediately prior to dosing, one-half of the animals were further prepared by making epidermal abrasions longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The test material was applied, in the quantity of 3 g/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. No mortalities were observed throughout the study. Oedema and erythema were present on all sites for 72 hours and on five sites for four days. The remaining site, at this time, displayed erythema. On the fifth day of scoring, four animals demonstrated erythema and two demonstrated both edema and erythema. On days six, seven and eight, irritation grading showed three animals displaying erythema. After this time, all animals returned to normal. All gross necropsies were within normal limits. Based on the study results, the dermal LD50 of the test substance was found to be >3,000 mg/kg bw in NZ albino rabbits.