Orthosulfamuron

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test material:
IR5878
Batch number: FCF/T/159-99 (ex 20274/71)
Purity: 93.72 ± 1.05 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:
Species and Strain: Male and Female Sprague Dawley Crl: CD (SD) BR rats
Age: no more than three months
Body weight: 334 ÷ 350 g (males); 200 ÷ 221 g (females)
Housing: individually during the treatment period and then 5 animals/cage/sex in air-conditioned room.
Feed: GLP 4RF21 top certificate pelleted diet produced by Charles River Italia’s feed licensee Mucedola Srl, Settimo Milanese. The diet was supplemented by the Producer with vitamins and traces elements. The diet was available ad libitum to the animals. Water was distributed ad libitum to the animals.

Administration / exposure

Details on dermal exposure:

Approximately 24 hours before the test fur was clipped from the dorsal and ventral area of the trunk of the test animals. Care was taken to avoid abrading the skin which could alter its permeability. An area of about 6x5 cm of the body dorsal surface was cleared for the application of the test article. This area corresponded to about 10% of the total body surface.
The test artcile was applied uniformly onto a porous gauze which was moistened with 0.9% NaCL solution. Th treated area was covered with the porous gauze dressing fixed to the skin with hypoallergenic non-irritating tape. The test site was further covered in a suitable amnner in order to ensure that the animals could no ingest the test substance. At the end of the exposure period the residual test article was wiped off with water.

Duration of exposure:

Groups of 5 Sprague Dawley Crl: CD (SD) BR rats per sex were administered a dosage of 5000 mg/kg (limit dose) of IR5878, applied as such uniformly onto a porous gauze moistened with 0.9% NaCl solution (single 24-hour dermal application).
The animals were examined for mortality, clinical signs and body weight during the 14 days after the treatment.

Doses:

Groups of 5 Sprague Dawley Crl: CD (SD) BR rats per sex were administered a dosage of 5000 mg/kg (limit dose) of IR5878, applied as such uniformly onto a porous gauze moistened with 0.9% NaCl solution (single 24-hour dermal application).

No. of animals per sex per dose:

Groups of 5 Sprague Dawley Crl: CD (SD) BR rats per sex

Details on study design:

The observation period was 14 days after the 24 hour exposure period.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortalities were observed in this test.

Clinical signs:

No clinical signs were observed in both sexes

Body weight:

Body weight was unaffected by treatment.

Gross pathology:

At gross necroscopy no macroscopic changes were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of IR5878 in rats was greater than 5000 mg/kg bw.

Executive summary:

Groups of 5 Sprague Dawley Crl: CD (SD) BR rats per sex were administered a dosage of 5000 mg/kg (limit dose) of IR5878, applied as such uniformly onto a porous gauze moistened with 0.9% NaCl solution (single 24-hour dermal application).

The dermal LD₅₀of IR5878 in rats was greater than 5000 mg/kg bw.