Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-135-3 | CAS number: 2370-63-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
Oral LD50 (rat, male/female) > 2000 mg/kg bw; OECD Guideline 401; GLP compliant, RL1
Supporting studies:
Oral LD50 (mouse, male/female) > 8200 mg/kg bw (95% c.i. 5200 – 13300 mg/kg bw); equivalent to OECD Guideline 401; pre-GLP, RL2 (Basic data given: comparable to guidelines)
Oral LD50 (rat, sex not given) > 5000 mg/kg bw; pre-GLP, RL3 (Documentation insufficient for assessment)
Acute dermal toxicity:
Dermal LD50 (rat, male/female) > 2000 mg/kg bw; OECD Guideline 402; GLP compliant, RL1
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-07-08 to 1993-07-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24th February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague-Dawley ICO: OFA-SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: app. 6 weeks
- Weight at study initiation: 189 ± 2 g (males), 158 ± 8 g (females)
- Fasting period before study: app. 18 h before and 4 h after dosing
- Housing: in groups of 5 by sex during treatment, polycarbonate cages covered with a stainless steel lid
- Diet (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 50±20
- Air changes (per hr): app. 13
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweights were recorded on days 1 (=day of treatment), 5, 8, 15; clinical signs: several times following application; at least once daily thereafter
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: mortality: 0/10
- Mortality:
- No deaths occurred during the observation period.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- The body weight gain of the animals had slowed down slightly between days 1 and 5. Thereafter, between days 5 and 8, an increase of the body weight gain was noted. During the second week of the observation period, the body weight gain of the animals was normal.
- Gross pathology:
- Macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormalities.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 for ETMA in rats is > 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 401, adopted 24 February 1987, groups of fasted app. 6 week old Sprague-Dawley ICO: OFA-SD rats (5/sex) were given a single oral dose of ETMA (99.94% a.i.) by gavage at a dose level of 2000 mg/kg bw and observed for 14 days.
No deaths occurred during the observation period.
No clinical signs were observed during the study period.
The body weight gain of the animals had slowed down slightly between days 1 and 5. Thereafter, between days 5 and 8, an increase of the body weight gain was noted. During the second week of the observation period, the body weight gain of the animals was normal.
Macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormalities.
Oral LD50 (rat, male/female) > 2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study is GLP compliant and of high quality (Klimisch score = 1). This finding is supported by further studies (pre-GLP, RL2/3).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-07-06 to 1993-07-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 24th February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague-Dawley ICO: OFASD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: app. 8 weeks
- Weight at study initiation: 248 ± 8 g (males), 218 ± 7 g (females)
- Fasting period before study: no
- Housing: individually during treatment, polycarbonate cages covered with a stainless steel lid
- Diet (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5x6 cm (females), 5x7 cm (males)
- % coverage: 10% body surface area
- Type of wrap if used: gauze patches were held in contact with the skin by means of
adhesive hypoallergic aerated semi-occlusive dressing and restraining bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (no residual test substance was observed after patch removal)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweights were recorded on days 1 (=day of treatment), 5, 8, 15; clinical signs: several times following application; at least once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: necropsy of dead animals - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: 20% mortality at this dose level
- Mortality:
- 2/5 females were found dead 24 hours after treatment without any preclinical signs.
- Clinical signs:
- No clinical signs and cutaneous reactions were observed during the study.
- Body weight:
- Between days 1 and 5, a decrease in body weight was noted for 1/5 males, the bodyweight gain was slightly reduced for 1/5 males and 2/5 females. The body
weight of these animals showed an improvement during the remainder of the observation period. This finding was probably due to the stress caused by the experimental conditions and was not attributed to treatment with the test substance
The body weight gain of the surviving animals was normal. - Gross pathology:
- Macroscopic examination of the main organs of the animals found dead during the study or sacrificed at the end of the study revealed no apparent abnormalities.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 for ETMA in rats is >2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study according to OECD guideline 402, adopted 24 February 1987, 5 male and 5 female app. 8 weeks old Sprague-Dawley ICO: OFASD rats were dermally exposed to ETMA (99.94% a.i.) for 24 hours under a semiocclusive dressing to approx. 10% of body surface area at a single dose of 2000 mg/kg bw. Animals then were observed for 14 days.
2/5 females were found dead 24 h after treatment without any preclinical signs.
No clinical signs and cutaneous reactions were observed during the study.
Between days 1 and 5, a decrease in body weight was noted for 1/5 males, the bodyweight gain was slightly reduced for 1/5 males and 2/5 females. The body weight of these animals showed an improvement during the remainder of the observation period. This finding was probably due to the stress caused by the experimental conditions and was not attributed to treatment with the test substance. The body weight gain of the surviving animals was normal.
Macroscopic examination of the main organs of the animals found dead during the study or sacrificed at the end of the study revealed no apparent abnormalities.
Dermal LD50 (rat, male/female) > 2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study is GLP compliant and of high quality (Klimisch score = 1).
Only one study available, but no adverse effects also for other routes at highest dose/conc. tested
Additional information
Reliable, relevant and adequate data are available for the acute oral and dermal toxicity of ETMA.
Acute oral toxicity
In an acute oral toxicity study according to OECD guideline 401, adopted 24 February 1987, groups of fasted app. 6 week old Sprague-Dawley ICO: OFA-SD rats (5/sex) were given a single oral dose of ETMA (99.94% a.i.) by gavage at a dose level of 2000 mg/kg bw and observed for 14 days.
No deaths occurred during the observation period. No clinical signs were observed during the study period. The body weight gain of the animals had slowed down slightly between days 1 and 5. Thereafter, between days 5 and 8, an increase of the body weight gain was noted. During the second week of the observation period, the body weight gain of the animals was normal.
Macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormalities.
Oral LD50 (rat, male/female) > 2000 mg/kg bw.
This is supported by the following studies:
In an acute oral toxicity study similar to OECD guideline 401, groups of fasted, CFLP mice (20 - 23 g), 5/sex were given a single oral dose of undiluted ETMA (no information on purity) at dose levels of 0, 4.0, 6.4, 8.0, 10.0, 12.6, 16.0 mL/kg bw, corresponding to ca. 3850, 6160, 7700, 9600, 12100 and 15400 mg/kg bw (based on the density of 0.9632 g/cm³) and observed for 14 days.
Up to a dose of 6.4 mL/kg bw no deaths occurred. 3/5 males and 2/5 females died in the 8 mL/kg bw dose group, 2/5 males and 2/5 females died in the 8.0 mL/kg bw dose group, 5/5 males and 3/5 females died in the 12.6 mL/kg bw dose group, and 4/5 males and 4/5 females died in the 16.0 mL/kg bw dose group.
Signs of reaction to treatment included lethargy and piloerection. These signs were accompanied by fine body tremors in mice at 8 mL/kg bw and by diuresis and increased salivation in mice treated at 10 and 16 mL/kg bw. Recovery of the survivors was apparently complete within 7 days after treatment.
Slightly depressed body weight gains were observed during the first week of observation in mice treated with 16 mL/kg bw, but returned to normal during the second week.
Autopsy of the animals that dies during treatment revealed darkening of the liver and kidneys and injection of vessels of the abdominal viscera. Terminal necropsy findings of the surviving animals were normal.
Oral LD50 > 8.6 mL/kg bw (95% c.i. 5.4 – 13.8 mL/kg bw), corresponding to 8200 mg/kg bw(95% c.i. 5200 – 13300 mg/kg bw).
In an acute oral toxicity study albino rats were given a single oral dose of ETMA(98.8% a.i.)in corn oil at doses of 3000 and 5000 mg/kg bw. The observation period was not given in the study report.
No mortality occurred. In the 3000 mg/kg bw dose group one animal was sensitive to touch 24 h after dosing. In the 5000 mg/kg bw dose group two animals were slightly hunched and sensitive to touch 24 h after dosing. No other signs of toxicity were observed.
The oral LD50 of ETMA in rats was > 5000 mg/kg bw.
Acute inhalation toxicity
A study on acute inhalation toxicity is unjustified in accordance to REACH regulation Annex VIII, column 2 due to exposure considerations as well as in accordance to REACH regulation Annex XI due to scientific considerations. The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Furthermore, systemic toxicity relevant to humans did not appear in acute by oral or dermal exposure. Considering the exposure probability and the available information on the intrinsic toxic activity of the substance, an inhalative systemic toxicity risk to humans is unlikely and therefore, the conduct of an inhalative toxicity study is not scientifically necessary. Thus, also animal welfare is respected according to REACH intentions.
Acute dermal toxicity
In an acute dermal toxicity study according to OECD guideline 402, adopted 24 February 1987, 5 male and 5 female app. 8 weeks old Sprague-Dawley ICO: OFASD rats were dermally exposed to ETMA (99.94% a.i.) for 24 hours under a semiocclusive dressing to approx. 10% of body surface area at a single dose of 2000 mg/kg bw. Animals then were observed for 14 days.
2/5 females were found dead 24 h after treatment without any preclinical signs.
No clinical signs and cutaneous reactions were observed during the study.
Between days 1 and 5, a decrease in body weight was noted for 1/5 males, the bodyweight gain was slightly reduced for 1/5 males and 2/5 females. The body weight of these animals showed an improvement during the remainder of the observation period. This finding was probably due to the stress caused by the experimental conditions and was not attributed to treatment with the test substance. The body weight gain of the surviving animals was normal.
Macroscopic examination of the main organs of the animals found dead during the study or sacrificed at the end of the study revealed no apparent abnormalities.
Dermal LD50 (rat, male/female) > 2000 mg/kg bw.
There are no data gaps in acute toxicity. Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.
Consistency of data on read-across chemicals:
A fully reliable study is available for acute oral toxicity of ETMA, so read across is not employed for this endpoint.
The source substances 2-Ethoxyethanol and Methcrylic acid were of similarly low toxicity after single administration. Diluted Methacrylic acid had an LD50 of >2000 mg a.i./kg bw (25% dilution in water or 10% dilution in corn oil). The LD50 of 2-ethoxyethanol was 3000 mg/kg bw in rat and 1400 mg/kg bw in guinea pigs.
The comparable outcome of the acute toxicity studies conducted with the target substance and the source substances supports the read-across hypothesis.
Justification for classification or non-classification
Based on the available data, ETMA does not need to be classified for acute toxicity according to regulation (EC) 1272/2008 or the former European directive on classification and labelling 67/548/EEC. Thus, no labelling is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.