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Description of key information

Ethyltriglycol methacrylate is of low acute oral and dermal toxicity. LD50 is higher than 2000 mg/kg bw in rats. 
Acute oral toxicity: LD50 (rat, combined) >= 5100 mg/kg bw; OECD Guideline 401, Non-GLP (Klimisch score = 2) (International Bio-Research (IBR) Forschungs GmbH, 1986) Supported by LD50 (rat, combined, limit test): > 2000 mg/kg/bw, OECD Guideline 401, GLP (Klimisch score = 1) (C.I.T. Centre International de Toxicologie, 1991)
Acute inhalation toxicity: no relevant route of exposure
Acute dermal toxicity: LD50 (rat) > 2000 mg/kg bw, Gudeline study according to OECD 402 with GLP (Klimisch score = 1) (BSL BIOSERVICE Scientific Laboratory GmbH, 2011)

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study with acceptable restrictions. Non GLP.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
not specified
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: SPF Wistar rats, sustrain TNO, Zucht Winkelmann, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: male. 211.6 - 239.8 g, female: 160.0 - 182.1 g
- Fasting period before study: 16 hours before administration, about 4 hours after application food was made available again
- Housing: Macrolon type III/ max 5 per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±2 °C
- Humidity (%): 50 - 85 %
- 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:
Range finding: 5, 2.5 and 1 mL/kg
Main study: 5 mL/kg
No. of animals per sex per dose:
5 m and 5 f per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of clinical observations: 15 min, 45 min, 1h, 2+3h, 6h,24/48h, 7d, 14d
- Frequency of measuring of the body weights: once at day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, other: avareness, reflexes, emotions, CNS-symptoms, coordination, autonomous functions, tone, respiration rate, body temperature
Statistics:
LD50 and it's confidence limits were calculated by the method of Finney DY: Probit Analysis, third ed., Cambridge, 1971.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Original value: LD50: > 5000 ml/kg, 14 days LD50; equals LD50: > 5100 mg/kg with a density of 1.02 g/cm³
Mortality:
No mortality observed.
Clinical signs:
The sample induced in the tested dosage obvious disturbed awareness with apathy, mainly obvious disturbance of coordination with abnormal body posture, slight reduced reflex excitability, slight piloerection and partly slight decreased respiration rate. The symptomes decribed above were observed first about 15 min. p.a. and last first in increased than in decreased intensity partly up to 6 h p.a.. Afterwards all animals showed a normal disposition.
Body weight:
Changes after the observation period (at day 14) showed a normal body weight gain.
Other findings:
No macroscopic findings in the cranial-, thoracic- and abdominal cavity.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
According to the test result: LD50(14days) > 5100 mg/kg bw the test substance Ethyltriglycol methacrylate has to be classified as nontoxic in
respect of its acute oral toxicity.
Executive summary:

In an acute oral toxicity study according to OECD 401, a group of fasted male and female SPF Wistar rats were given a single oral dose of Ethyltriglycol methacrylate at a limit dose of 5000 ml/kg bw and observed for 14days.

 

Oral LD50Combined = > 5000 ml/kg bw equals ca. 5100  mg/kg  bw

OECD 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)).

    

Based on the results of this study ( LD50 limit test in male and female rats) Ethyltriglycol methacrylate is not classified according to EU-GHS and OECD GHS criteria.

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
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 100 mg/kg bw
Quality of whole database:
There are two relevant, adequate and reliable studies for Ethyltriglycol methacrylate available (International Bio-Research (IBR) Forschungs GmbH, 1986 (Klimisch score = 2) and C.I.T. Centre International de Toxicologie, 1991 (Klimisch score = 1). The tests were performed in accordance with generally accepted scientific standards and described in sufficient detail. Guideline studies.

Acute toxicity: via inhalation route

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:
2011-11-02 to 2011-11-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Gudeline study OECD 402, GLP.
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
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: 236-249 g, females: 208-220 g
- Fasting period before study: no
- 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 (drinking water, municipal residue control, microbiological controls at regular intervals)
- 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
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk, approx. 10 % of the total body surface
- % coverage: 10 % of the total body surface
- Type of wrap if used: gauze-dressing and non-irritating tape, fixed with additional dressing in suitable manner.

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
- Concentration (if solution): n/a (undiluted)
- Constant volume or concentration used: yes (single dose)
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:
other: Untreated skin areas of the test animals serve as the control
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, gross pathological changes
-- In case of gross pathological changes, tissues were preserved for a possible histopathological evaluation.
-- The treated areas of skin were examined daily for signs of primary skin irritation. Signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404, adopted 24th April 2002.

Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mortality 0/10 Limit test according to OECD 402.
Mortality:
No mortality observed. All animals survived until the end of the observation period of 14 days.
Clinical signs:
No signs of systemic toxicity were observed.
The nasal discharge observed 1 day post-dose in one female animal is not considered to be related to the test item, but to the administration
procedure and the possible stress induced.
Signs of irritation: Erythema grade 1 was observed in 2/5 female animals at day 2 and 3, the 2 animals recovered at days 4 to erythema grade 0. No signs of irritation were seen in male animals. The observed signs of irritation were reversible within the 14-day observation period.
Body weight:
A slight weight loss was recorded for 1 of 5 female animals during the first week, but all of the female animals showed weight gain during the
second week, The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded.
The male animals showed weight gain during the first and the second week of the observation.
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
According to the test result: LD50: > 2000 mg/kg bw (OECD 402, GLP) the test substance Ethyltriglycol methacrylate 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: 236 to 249g (m) and 208 to 220 g (f)), were given a single dermal dose of undiluted Ethyltriglycol methacrylate (purity: 98.95%) at a dose of 2000 mg/kg bw. Animals were then observed for 14 days.

 

Dermal LD50Males/Females =  > 2000 mg/kg bw

 

Ethyltriglycol methacrylate 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
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
There is one relevant, adequate and reliable (Klimisch score = 1) valid Gudeline study according to OECD 402 with GLP (BSL BIOSERVICE Scientific Laboratory GmbH, 2011) for Ethyltriglycol methacrylate available.

Additional information

Ethyltriglycol methacrylate is of low acute oral and dermal toxicity.

LD50: > 5100 mg/kg bw (oral rat, standard acute method) supported by LD50: > 2000 mg/kg/bw (oral, rat, standard acute method, limit test, single dose) is higher than 2000 mg/kg bw in rats. In a GLP limit test performed according to OECD guideline 402, the dermal LD50 of Ethyltriglycol methacrylate was found to be higher than 2000 mg/kg bw in rats (BSL BIOSERVICE Scientific Laboratory GmbH, 2011).


Justification for selection of acute toxicity – oral endpoint
Test was performed in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study with acceptable restrictions.

Justification for selection of acute toxicity – dermal endpoint
Gudeline study according to OECD 402 with GLP.

Justification for classification or non-classification

Based on the available oral and dermal data LD50 are higher than 2000 mg/kg bw in rats, Ethyltriglycol methacrylate is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Thus, no labelling is required.