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Administrative data

Description of key information

Ethyleneglycol dimethacrylate is of low acute oral and dermal toxicity. LD50 is higher than 2000 mg/kg bw in rats. 

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Pre-guideline study. Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. Comparable to guideline study with acceptable restrictions.
Qualifier:
according to
Guideline:
other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics, FDA"
Principles of method if other than guideline:
Method: in accordance with Appraisal of the safety of chemicals in food, drugs and cosmetics, FDA (1959)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF Wistar rats, Zucht Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 145 - 225 g
- Fasting period before study: 16 hours
- Housing: 5 m, 5 w animals per group
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
7.94, 8.89, 10.00, 11.20, 12.60 ml/kg
No. of animals per sex per dose:
5f/5m per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighting: 20 min, 1h, 3h, 24h, 48h, 7d, 14d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: reflexes, emotions, consciousness, central
symptoms, autonomous functions, tone
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 300 mL/kg bw
Based on:
test mat.
95% CL:
7.69 - 8.96
Remarks on result:
other: 14 days LD50; equals LD50: 8700 mg/kg with a density of 1.055
Mortality:
In all the dose groups mortalities occurred within 5 days. In the first group 4/10 and second dose group 7/10 animals died, in the third dose group 8/10 and in the fourth and fifths dose group 10/10 animals died after 14 days.
Clinical signs:
Dose-dependent effects e.g. decreased activity, distributed coordination, piloerection; in high dose groups: anomalous attitude, tremor; symptoms occurred 20 min after administration of TS and lasted for 24 h, after that all animals showed normal behaviour.

Table (I) Mortality (mortalities occurred within 5 days p.a.)

 group   dose  24 hours (p.a.)  14 days (p.a.)
 (I)  7.94 ml/kg  0/10  4/10
 (II)  8.89 ml/kg   3/10  7/10
 (III)  10.0 ml/kg  6/10  8/10
 (IV)  11.20 ml/kg  6/10  10/10
 (V)  12.60 ml/kg  8/10  10/10

Table(II) Weight development

group/ number of animals   mean weight (ante application; a.a.)   mean weight (post application; p.a.) after 14days
 (I) / 5f, 5m  166.0 g  190.8 g
 (II) / 5f, 5m   194.0 g  221.7 g
 (III) / 5f, 5m   177.0 g  170.0 g
 (IV) / 5f, 5m  178.5 g    - 
 (V) / 5f, 5m  168.5 g    - 

Remark: Except the animals I-9 and III-8 (very haggard animals) all the other test animals showed at the  end of the post exposure period of 14 days normal body weight gain.

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
According to the test result: LD50(14days) 8700 mg/kg bw the test substance Ethylene glycol dimethacrylate has to be classified as nontoxic in
respect of its acute oral toxicity.
Executive summary:

In an pre-guideline acute oral toxicity study, groups of fasted male and female SPF Wistar rats were given a single oral dose of Ethylene glycol dimethacrylate > 98.5 % at doses of 7.94, 8.89, 10.00, 11.20 and 12.60 ml/kg bw and observed for 14 days.

 

Oral LD50Combined = 8.30 ml/kg bw equals ca. 8700  mg/kg  bw

GHS Category 5 ranges from 2000 -5000 mg/kg bw and represents the lowest hazard category for classifying the acute oral toxicity of a chemical substance. ("Criteria for hazard Category 5 are intended to enable the identification of the test substances which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations". (OECD guideline 425 annex 4)).

    

Ethylene glycol dimethacrylate is of very low oral toxicity based on this LD50 test in males and females.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion
Dose descriptor:
LD50
Value:
8 700 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Screening-test. Only very short summary available. Only one dose, only one sex, only 3 animals.
Principles of method if other than guideline:
Screening-test
GLP compliance:
no
Test type:
other: subacute
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
female
Route of administration:
inhalation: vapour
Vehicle:
air
Duration of exposure:
6 - 7 h
Remarks on duration:
subacute study: 13 x daily; 5 days a week
Concentrations:
1 mg/L (120 ppm)
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
Post-exposure period: no, Animals were killed at the end of exposure period.
Three rats were exposed to air which had been bubbeled through the test substance. From the measured loss in weight of the liquid the atmospheric concentration was calculated.
Preliminary study:
The animals became somewhat lethargic during the exposures but no definite symptomes developed. Normal weight gain. The post mortem examination showed some discolouration of the lungs. A histological examination of the lungs showed some thickening of the alveolar walls with a lymphocytic reaction around the bronchioles. The other major organs showed no signs of patological changes.
Sex:
female
Dose descriptor:
LCLo
Effect level:
> 1 mg/L air
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: 1 mg/L corresponds to 120 ppm; exposure 6 or 7 hrs/d; screening test performed for 13 days
Mortality:
No mortality.
Body weight:
Normal weight gain.
Gross pathology:
The other major organs showed no signs of patological changes.
Interpretation of results:
GHS criteria not met

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:
2011-11-02 to 2011-11-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 Feb, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
EPA 712-C-98-192, Aug., 1998
Deviations:
no
Principles of method if other than guideline:
Method: standard acute method
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: ca. 9 weeks, females: ca. 13 weeks
- Weight at study initiation: males: 231-247 g, females: 217-229 g
- Fasting period before study:
- Housing: full barrier, air-conditioned room, animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre
bedding
- Diet: ad libitum; Altromin 1324 maintenance diet for rats and mice
- Water: ad libitum; tap water, sulfur acidified to a pH value of ca. 2.8
- Acclimation period: at least five days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): artificial light, 12 hours light, 12 hours dark
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10 % of the total body surface
- Type of wrap if used: gauze-dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 2000 mg/kg/bw
Duration of exposure:
24 hours
Doses:
Limit test: 2000 mg/kg/bw
No. of animals per sex per dose:
10; 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighted on day 1 (prior to the application) and on day 8 and 15
Clinical examination was made several times on the day of dosing (at least once during the first 30 minutes). Thereafter, clinical signs were
recorded once daily until the end of observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Limit test according to OECD 402.
Mortality:
No mortality observed.
Clinical signs:
Signs of irritation: Erythema grade 2 was observed in 1/5 female animals, erythema grade 1 was observed in 2/5 female animals. Eschar was seen in 2/5 female animals. No signs of irritation were seen in male animals. The observed signs of irritation were reversible within the 14-day observation period.
Body weight:
No treatment-related effects were observed.
Gross pathology:
No treatment-related effects were observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the test result: LD50: > 2000 mg/kg bw (OECD 402, GLP) the test substance Ethyleneglycol dimethacrylate has to be classified as practically nontoxic in rats in respect of its acute dermal toxicity (EU GHS criteria; classification based on the criteria of 286/2011/EC).
Executive summary:

In an acute dermal toxicity study (Limit test according to OECD 402), a group of 5 male and 5 female Wistar Crl: WI(Han) rats (source: Charles River, age: 9 weeks (m) and 13 weeks (f), weight: 231 to 247g (m) and 217 to 229 g (f)), were given a single dermal dose of undiluted Ethyleneglycol dimethacrylate (purity: 99.88%) at a dose of 2000 mg/kg bw. Animals were then observed for 14 days.

 

Dermal LD50Males/Females =  > 2000 mg/kg bw

 

Ethyleneglycol dimethacrylate is practically nontoxic in rats based on the dermal LD50in rats. The substance has no toxicity category according to Annex VI to Commission Directive 2001/59/EC, REGULATION (EC) No 1272/2008 and according to OECD GHS criteria.

There were no treatment related signs of mortality or signs of toxicity but signs of irritation. All signs of irritation were reversible within the observation period.

This acute dermal limit test study is classified as acceptable. It does satisfy the requirements for an acute dermal study in the rats according to OECD 402. 

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Ethyleneglycol dimethacrylate is of low acute oral and dermal toxicity. LD50: 8700 mg/kg bw (oral rat, standard acute method) is higher than 2000 mg/kg bw in rats. In a recent GLP limit test performed according to OECD guideline 402, the dermal LD50 of EGDMA was found to be higher than 2000 mg/kg bw in rats with no mortality or relevant signs of toxicity.

Compliance to REACh requirements

The requirements are covered with reliable studies for all three exposure routes, all performed with the substance itself.

Justification for classification or non-classification

As oral and dermal LD50 are higher than 2000 mg/kg bw in rats, Ethyleneglycol dimethacrylate is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008) nor according to UN-GHS.