Ethyl [(4-methylphenyl)sulphonyl]carbamate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Remarks:

other: Repeat dose study

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP. Guideline study

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl [(4-methylphenyl)sulphonyl]carbamate

EC Number:

226-952-9

EC Name:

Ethyl [(4-methylphenyl)sulphonyl]carbamate

Cas Number:

5577-13-9

Molecular formula:

C10H13NO4S

IUPAC Name:

ethyl [(4-methylphenyl)sulfonyl]carbamate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Duration of treatment / exposure:

At least 28 days. Animals were dosed up to the day prior to necropsy.

Frequency of treatment:

Once daily, 7 days for weed, approximetely the same time each day with a maximum of 6 hours difference between the earliest and latest dose.

Doses / concentrations

Remarks:

Doses / Concentrations:

Basis:

No. of animals per sex per dose:

20 males and 20 females: 1 control group and 3 treated groups, each consisting of 5 males and 5 females.
Dose level: 0, 30, 300 and 1000 mg/kg.

Results and discussion

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

300 mg/kg bw (total dose)

Sex:

male/female

Basis for effect level:

behaviour (functional findings)

body weight and weight gain

clinical biochemistry

clinical signs

food consumption and compound intake

haematology

mortality

organ weights and organ / body weight ratios

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

- No mortality occurred during the study period.

- All females at 1000 mg/kg showed hunched posture from week 1 of treatment onwards.

- Females at 300 and 1000 mg/kg showed a reducd motor activity.

- All groups showed a similar motor activity habituation profile with high activity in the first interval that decreased over the duration of the test period.

- Males at 1000 mg/kg showed a reduced body weight and body weight gain throughout the treatment period, achieving a level of statistical significance on most occasions.

- No toxicologically relevant changes occured in haematological parameteres of treated rats.

- Necropsy did not reveal any toxicologically relevant alterations.

Applicant's summary and conclusion

Conclusions:

In general, females appeared more sensitive to develpment of treatment-related effects. Findings at 300 mg/kg were not supported by any other functional or morphological changes, and were therefore considered not to represent and adverse effect on the general integrity of the test system. given the number of treatment-related alterations at 1000 mg/kg, the No Observed Adverse Effect Level (NOAEL) was established at 300 mg/kg.