1,8-bis(phenylthio)anthraquinone

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13-13-2001/3-01-2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-Chloro-benzoylamino)-4(phenylthio)anthraquinone

IUPAC Name:

1-(2-Chloro-benzoylamino)-4(phenylthio)anthraquinone

Constituent 2

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

other: HanBrl:WIST (SPF)

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Duration of exposure:

24 h

Doses:

The test item 2000 mg/kg dose was diluted in the vehicle at a concentration of 0.5 g/mL and administered at as a volume of 4 mL/kg.

No. of animals per sex per dose:

5 females and 5 males

Control animals:

not required

Details on study design:

- Mortality/ Viability: Daily during acclimatization and twice daily during days 1-15.
- Body weights: On test days 1 (pre-administration), 8 and 15.
- Clinical signs: Daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred throughout the study.

Clinical signs:

other: Red skin and test item residuals were evident in all animals from test day 2 to days 7 or 11. Slight scales on the back were observed in wo males and two females from test day 8 until test day 11.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of FAT 41034/A after single dermal administration to rats of both sexes, observed over a period of 14 days was greater than 2000 mg/kg bw.

Executive summary:

A group of five male and five female HanBrl: WIST rats were treated with FAT 41'034/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/mL and administered at a volume of 4 mL/kg. The animals were examined for clinical signs four times during test day1 and once daily during the test days 2 -15. Mortality/viability was recorded together with the clinical signs at the same time intervals on the test day1. During the test days 2 -15 it was recorded two times a day. BW were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred throughout the study. Red skin and test item residuals were evident in all animals from test day 2 to days 7 or 11. Slight scales on the back were observed in two males and two feamles from test day 8 until test day 11. The bw of the animals were within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. As a conclusion, the median lethal dose of FAT 41034/A after single dermal administration to rats of both sexes, observed over a period of 14 days was greater than 2000 mg/kg bw.