2-chloro-5-methoxybenzene-1-sulfonamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF 12-Nousan-8147 (2000)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

1

Reference substance name:

2-chloro-5-methoxybenzene-1-sulfonamide

Cas Number:

502187-53-3

Molecular formula:

C7H8ClNO3S

IUPAC Name:

2-chloro-5-methoxybenzene-1-sulfonamide

Specific details on test material used for the study:

Test substance: IN-F4106-009
Lot number: CCS-1213/STG-01/00112 BL
Purity: 97.2%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

not specified

Vehicle:

water

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: Other than the dermal irritation noted at one dose site on Day 1, there were no other clinical findings recorded for any animal over the course of the study.

Body weight:

other body weight observations

Remarks:

All animals gained body weight.

Gross pathology:

No gross abnormalities were noted for any of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Rat Dermal LD50 (male and female): >5000 mg/kg bw.

Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for the test substance to produce toxicity from a single topical application according to the guidelines OECD 402, US EPA OPPTS 870.1200, EC B.3, JMAFF 12-Nousan-8147 .

Five thousand milligrams of the test substance per kilogram of body weight was moistened with distilled water and then applied to a patch and then to the skin of ten healthy rats (five male and five female) for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days. Body weights were recorded prior to application (initial) and again on Days 7 and 14 (terminal). Necropsies were performed on all animals at terminal sacrifice.

All animals survived test substance administration, gained body weight, and appeared active and healthy during the study. Other than the dermal irritation noted at one dose site on Day 1, there were no other clinical findings recorded for any animal over the course of the study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 5000 mg/kg of body weight in male and female rats.