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Diss Factsheets
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EC number: 230-241-9 | CAS number: 6976-93-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin irritation:
- not irritating in rabbits: OECD Guideline 404; GLP; RL1; undiluted
test material applied to the intact skin of 3 animals for 4 hours; very
slight to moderate cutaneous reactions (erythema grade 1 and 2) were
observed for up to 72 hours (2/3 animals) or 4 d (1/3 animals); fully
reversible within 4 - 5 days; read-across from ETMA
Eye irritation:
- not irritating in rabbits: OECD Guideline 405; GLP; undiluted test
material applied to left eye of 3 animals without washing; slight
redness (grade 1) of the conjunctiva in 2/3 animals after 1 hour, no
ocular reactions 24, 48 and 72 hours after treatment; read-across from
ETMA
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: methacrylate esters
• the metabolism pathway leads to comparable products (methacrylic acid and short chain alcohol).
Therefore, read-across from the existing (eco)toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see crossreference “Justification for read-across”
3. ANALOGUE APPROACH JUSTIFICATION
see crossreference “Justification for read-across”
4. DATA MATRIX
see crossreference “Justification for read-across” - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 4 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: methacrylate esters
• the metabolism pathway leads to comparable products (methacrylic acid and short chain alcohol).
Therefore, read-across from the existing (eco)toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see crossreference “Justification for read-across”
3. ANALOGUE APPROACH JUSTIFICATION
see crossreference “Justification for read-across”
4. DATA MATRIX
see crossreference “Justification for read-across” - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Observation period (in vivo):
- 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the rabbit eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
No experimental data on MTMA are available for the assessment of skin and eye irritation. However, studies are available for the source substance ETMA. A detailed justification for read-across is attached to IUCLID section 13.
Hypothesis for the analogue approach
The read-across hypothesis relies on the close structural similarity between the source substance ETMA and the target substance MTMA, differing only by one CH2-group. This read-across hypothesiscorresponds to scenario 2 -different compounds have qualitatively similar properties- of the read-across assessment framework i.e.properties of the target substance are predicted to be quantitatively equal to those of the source substance. Namely, the structurally similar source substance ETMApredicts the toxicological properties of the target substance MTMA.
Toxicological data are summarised in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.
Therefore, read-across from the existing toxicity studies conducted with the source substance is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
A detailed justification for the proposed read-across approach is attached to Iuclid section 13.
Common assessment elements for analogue approaches:
AE A.1 Characterisation of source and target substances
There is close structural similarity between the source and the target substances and the identity and characterisation of these substances is unambiguous thereby giving a high level of confidence in the validity of the read across.
The target and source substances are highly pure mono-constituent substances. They do not contain impurities, which would be of toxicological concern.
The target substance MTMA is an ester of Methacrylic acid and 2-Methoxyethanol. It is produced by esterification of Methacrylic acid and 2-Methoxyethanol.
The source substance ETMA is an ester of Methacrylic acid and 2-Ethoxyethanol. It is produced by esterification of Methacrylic acid and 2-Ethoxyethanol. ETMA is different to MTMA in only one CH2-group.
AE A.2 Link of structural similarities and structural differences with the proposed prediction
The read-across hypothesis relies on local effects mediated by electrophilic reactivity of the parent ester. Hydrolysis occurs at the site of this ester bond so is a detoxification process with respect to nucleophilic action
AE 2.2 Common underlying mechanism
Since carboxylesterases are widely distributed throughout the body and the half-life of the parent ester is very short the impact of parent compound (AE 1.4) is unlikely to be significant other than at the site of initial contact. Indeed, local hydrolysis at the site of contact is likely to be very rapid thereby minimising exposure to parent ester even at local targets. Since the source and target compounds are monoconstituents of high purity there are no impurities worthy of consideration.
AE A.3 Reliability and adequacy of the source study
All available studies have been conducted according to OECD guidelines and have been assigned a reliability of 1 as documented in the data matrix (see detailed justification for read-across attached to Iuclid section 13).
Overall, the study design of the respective source studies is adequate and reliable for the purpose of this read-across.The results of the selected key studies are adequate for classification and labelling and for risk assessment purposes.
Data availability
Skin irritation
In a primary dermal irritation study according to OECD guideline 404, 3 male New Zealand white rabbits were dermally exposed to 0.5 mL of ETMA for 4 h to ca. 6 cm² body surface area. Animals then were observed for 6 days. Irritation was scored by the method of Draize.
Very slight to moderate cutaneous reactions (erythema grade 1 and 2) were observed for up to 72 hours (2/3 animals) or 4 d (1/3 animals) after the removal of the dressing. From day 3 to 6, a dryness of the skin was observed at the treatment site in 1/3 animals. During the whole observation period, the animals were free of oedema. All effects were fully reversible within 4 or 5 days.
In this study, ETMA is not a dermal irritant.
Eye irritation
In a primary eye irritation study according to OECD guideline 405, 0.1 mL of ETMA was instilled into the conjunctival sac of 3 young adult New Zealand White rabbits without washing. The untreated right eye served as control. Animals then were observed for 3 days. Irritation was scored by the method of Draize.
Slight redness (grade 1) of the conjunctiva was noted in 2/3 animals after 1 hour. No ocular reactions were observed 24, 48 and 72 hours after treatment.
In this study, ETMA is not irritating to the rabbit eye.
There are no data gaps in skin and eye irritation. Even though there is no information on irritation in humans, there is no reason to believe that the lack of irritation potential observed in experimental animals would not be relevant for human health.
Justification for classification or non-classification
Based on the available data, MTMA does not need to be classified for eye irritation or skin irritation according to regulation (EC) 1272/2008. 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.
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