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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Vinyl chloroacetate
EC Number:
219-834-3
EC Name:
Vinyl chloroacetate
Cas Number:
2549-51-1
Molecular formula:
C4H5ClO2
IUPAC Name:
ethenyl 2-chloroacetate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks.
- Weight at study initiation: Females: 203 - 222 g. Males: 230 - 231 g.
- Housing: Groups of three in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet N°1 (Special Diets Services Limited) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Five days.

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
Test substance was administrated as supplied for the 200 mg/kg bw dose level.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 mg/mL (200 mg/kg bw dose level)
- Amount of vehicle (if gavage): 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The information available suggested a starting dose of 2000 mg/kg bw.
Doses:
200 mg/kg bw, 2000 mg/kg bw.
No. of animals per sex per dose:
200 mg/kg bw: 3 animals/sex
2000 mg/kg bw: 3 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity 30 min, 1h, 2h, and 4h after dosing and subsequently once daily. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment or at death.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
200 mg/kg bw
Based on:
test mat.
Mortality:
All animals treated with 2000 mg/kg bw and one female treated with 200 mg/kg were found dead during the day of dosing.
Clinical signs:
other: Common signs of systemic toxicity noted in animals treated with 2000 mg/kg bw were hunched posture, ataxia, loss of righting reflex, decreased respiratory rate, laboured respiration, coma and pallor of the extremities. Common signs of systemic toxicity no
Gross pathology:
Abnormalities noted during the necropsy of animals that died during the study were haemorrhagic lungs, dark liver, dark kidneys, epithelial sloughing and pale appearance of the gastric mucosa and haemorrhagic small intestine.
No abnormalities were noted at necropsy in animals killed at the end of the study.

Any other information on results incl. tables

See 'attached background material'

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute toxicity study by oral route was conducted on the registered substance according to the OECD Testing Guideline 423. The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 200 mg/kg body weight. As the majority of LD50 range falls into Acute Tox. Oral, Category 4 and the mean LD50 value would lie between 300 and 500 mg/kg bw, classification into category 4 was deemed applicable in accordance with Table 3.1.1 of Regulation (EC) No.1272/2008.
Executive summary:

The acute toxicity: oral of the test substance was determined during a GLP study performed in accordance with the OECD Guideline for Testing of Chemicals 423.

Three female Sprague-Dawley rats were treated at 2000 mg/kg bw. Following this treatment, three male and three female rats received 200 mg/kg bw. Clinical signs and body weight development were monitored for 14 days following the administration of the test substance. All animals were subjected to gross necropsy.

All animals treated with 2000 mg/kg bw and one female treated with 200 mg/kg were found dead during the day of dosing. Common signs of systemic toxicity noted in animals treated with 2000 mg/kg bw were hunched posture, ataxia, loss of righting reflex, decreased respiratory rate, laboured respiration, coma and pallor of the extremities. Common signs of systemic toxicity noted in animals treated with 200 mg/kg bw were hunched posture and lethargy with incidents or isolated incidents of diarrhoea, ataxia, decreased respiratory rate, laboured respiration and noisy respiration. Surviving animals showed expected gains in bodyweight over the study period and recovered one day after dosing.

The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 200 mg/kg body weight. As the majority of LD50 range falls into Acute Tox. Oral, Category 4 and the mean LD50 value would lie between 300 and 500 mg/kg bw, classification into category 4 was deemed applicable in accordance with Table 3.1.1 of Regulation (EC) No.1272/2008.