2-Propenoic acid, 2-isocyanatoethyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 December 2003 - 4 February 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Annex V (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 2nd December 2002, Date of signature: 13th February 2003

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-140-6

EC Name:

-

Cas Number:

13641-96-8

Molecular formula:

Hill formula: C6 H7 N O3 CAS formula: C6 H7 N O3

IUPAC Name:

2-isocyanatoethyl prop-2-enoate

Test animals

Species:

rat

Strain:

other: Crl: CD (SD) IGS BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd. Margate, Kent, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: within an interval of ±20% of mean initial bodyweight
- Fasting period before study: overnight immediately before and 3-4 hours after dosing
- Housing: Groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK; ad libitum
- Water (e.g. ad libitum): Mains dinking water; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%):30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Arachis oil BP

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 and 5 mg/mL, respectively
- Amount of vehicle (if gavage): volume administered to each animal calculated according to the fasted bodyweight at time of dosing

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: All available information on the toxicity of the test material

Doses:

300 and 50 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: death and overt signs of toxicity: 30 min, 1, 2, and 4 hours after dosing and subsequently once daily; weighing after 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external examination and opening of the abdominal and thoracic cavities for examination of major organs; macroscopic abnormalities were recorded

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

200 - 300 mg/kg bw

Mortality:

300 mg/kg:
1st step: 3/3 (after 2h)
2nd step: 1/3 (after 1d)

50 mg/kg: 0/6

Clinical signs:

other: Signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg were hunched posture, lethargy, ataxia and decreased respiratory rate. One animal treated at a dose level of 300 mg/kg appeared normal throughout the study. There were no

Gross pathology:

Effects on organs: Abnormalities noted at necropsy of animals that died during the study were abnormally red lungs, dark liver or patchy pallor of the liver, dark kidneys and slight haemorrhage of the gastric mucosa. Raised white foci on the non-glandular region of the stomach were noted at necropsy of two animals treated with 50 mg/kg. No abnormalities were noted at necropsy of all other animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

other: Acute Tox. 3 (H301) according to CLP Regulation (EC) No 1272/2008.