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Diss Factsheets

Administrative data

Description of key information

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.

No exposure of humans to the registered substance via inhalation is expected. Therefore it is not appropriate to perform testing on the substance by the inhalation, in accordance with Annex VIII of REACH, Column 2.

The acute toxicity: dermal of the test substance was determined during a GLP study performed in accordance with the OECD Guideline for Testing of Chemicals 402.

Five male and five female Sprague-Dawley rats were exposed to 2000 mg/kg bw of the test substance for 24h. 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.

No deaths were observed. Dermal exposure to the test substance did not induce observable adverse effects.

The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.

See 'attached background material'

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
200 mg/kg bw
Quality of whole database:
The study was performed on the test substance in accordance with the OECD Testing Guideline 423 and was GLP-compliant.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing by inhalation route is appropriate if exposure of humans via inhalation is likely. Vinyl Chloroacetate is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via inhalation is expected.
Clinical signs:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
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: 202 - 226 g. Males: 221 - 247 g.
- Housing: Individually during the exposure then groups of five 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
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: 10%
- Type of wrap if used: Surgical gauze with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with distilled water.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.67 mL/kg bw
- Constant volume or concentration used: yes
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
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 on Days 0, 7, and 14.
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
other: No signs of systemic toxicity were noted.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
No signs of dermal irritation were noted during the study.

See 'attached background document'

Interpretation of results:
GHS criteria not met
Conclusions:
The acute toxicity study by dermal route was conducted on the registered substance according to the OECD Testing Guideline 402. The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008.
Executive summary:

The acute toxicity: dermal of the test substance was determined during a GLP study performed in accordance with the OECD Guideline for Testing of Chemicals 402.

Five male and five female Sprague-Dawley rats were exposed to 2000 mg/kg bw of the test substance for 24h. 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.

No deaths were observed. Dermal exposure to the test substance did not induce observable adverse effects.

The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The study was performed on the test substance in accordance with the OECD Testing Guideline 402 and was GLP-compliant.

Additional information

Justification for classification or non-classification

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.

The acute toxicity study by dermal route was conducted on the registered substance according to the OECD Testing Guideline 402. The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008.