2-Propenoic acid, 2-isocyanatoethyl ester

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Feb 2011 - 04 Mar 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

adopted in 2009

Deviations:

yes

Remarks:

whole-body exposure although liquids aerosols were tested, particle size (MMAD) not determined, chamber conditions and age of animals not provided, not GLP

GLP compliance:

no

Remarks:

The study was performed to meet the requirements of a non-EU Regulatory Authority. A quality assurance statement was included.

Test type:

traditional 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:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shanghai SLAC Laboratory Animal Co., Ltd.
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 260 - 300 g
- Housing: Animals in each group were housed in a power exposure chamber
- Diet: standard diet, ad libitum (changed weekly)
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 Feb 2011 To: 15 Mar 2011

Administration / exposure

Route of administration:

inhalation: mist

Type of inhalation exposure:

whole body

Vehicle:

air

Remark on MMAD/GSD:

The mass median aerodynamic diameter (MMAD) was not determined.

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
power exposure chamber (Tianjin Hepu Co., Ltd.)
- Exposure chamber volume: 300 L
- System of generating particulates/aerosols:
The test substance was sprayed to the chamber with a sprayer.
- Method of particle size determination:
The particle size was not measured.

TEST ATMOSPHERE
- Brief description of analytical method and equipment used:
Every half an hour, the average of concentration of the sample in an atmosphere was estimated by adsorbing the sample onto silica gel, desorbing the sample with acetone and analysing it by gas chromatography.

VEHICLE
A group of animals (5 males and 5 females), which were exposed to air, served as the control group.

TEST ATMOSPHERE
- Particle size distribution:
Not measured.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
Not determined.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

18.15, 51.18, 117.20, 240.62 and 483.59 mg/m³

No. of animals per sex per dose:

5

Control animals:

yes

Remarks:

exposed to air

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed once daily. Body weight was measured once a week.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes

Statistics:

Statistical analysis were not performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

53.72 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

Mortality occurred as follows:
18.15 mg/m³: 0/5 males and 0/5 females
51.18 mg/m³: 2/5 males and 2/5 females
117.20 mg/m³: 5/5 males and 5/5 females
240.62 mg/m³: 5/5 males and 5/5 females
483.59 mg/m³: 5/5 males and 5/5 females

Clinical signs:

other: moist hair, cachexia, slow breathing, agitation, high sensitivity, salivation, scratching and combing

Remarks:

For details, please refer to the attached background material 1.

Body weight:

All animals gained body weight during the study.

Gross pathology:

Gross necropsy did not reveal any obvious abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: As the test atmosphere was judged as mist and according to the CLP Regulation (EC) No 1272/2008, classification for acute Tox. 2 (H330) is required.