2-({[3-(methylsulfanyl)phenyl]carbamoyl}oxy)ethyl prop-2-enoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 1

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Reference 2

Reference Type:

other:

Title:

Unnamed

Year:

2011

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(2001)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: RCCHan:WIST
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: 8-12 weeks approximately
- Weight at study initiation: 169-186 g
- Fasting period before study: Food was withheld from the animals for approximately 16-24 h before administration of the test item, and they were fed again approximately 2-4 h after administration.
- Housing: The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

Administration volume: 10 mL/kg bw

VEHICLE: polyethylene glycol 400

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (3 animals per step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily. The weight gain was checked weekly until the end of the study.
- Necropsy of survivors performed: yes

Statistics:

The LD50 value was estimated according to OECD TG 423 (2001).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: cut-off level according to OECD TG 423, Annex 2d

Mortality:

There were no deaths.

Clinical signs:

Decreased motility was observed in one animal.

Body weight:

There were no toxicologically significant effects on body weight or body weight gain.

Gross pathology:

The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study according to OECD TG 423 (Acute Toxic Class Method) was conducted on 6 female rats (3 per step), receiving each a single dose of 2000 mg/kg of the test item formulated in polyethylene glycol. No mortalities, no effects on body weight gain and no gross pathological findings were observed. Only decreased motility was observed in one animal. The LD50 of the test material was estimated from the flow chart of the OECD TG 423, Annex 2d, to be > 5000 mg/kg bw.