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EC number: 902-591-9 | CAS number: -
- 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
The reaction mass of methyl acetate and methanol is assessed on the basis of the individual constituents methyl acetate and methanol using a read-across approach from the supporting substances (structural analogue or surrogate).
Skin sensitisation
Methyl acetate
In two supporting studies (Klimisch score 4), no skin sensitising properties were observed for methyl acetate in humans.
Methanol
In an in vivo skin sensitisation study similar to OECD guideline 406 (Klimisch score 2), methanol induced slight erythema in guinea pigs but gives no evidence of a notable sensitisation potential.
Conclusion
Based on the results of skin sensitisation studies with the two source substances methyl acetate and methanol, skin sensitising properties of the reaction mass of methyl acetate and methanol is assessed. Both substances were found to be non-sensitisers. Therefore, the reaction mass of methyl acetate and methanol is not considered to have skin sensitising properties.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- review of literature and assessment of available human, animal and alternative data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Principles of method if other than guideline:
- review of literature and assessment of available human, animal and alternative data
- GLP compliance:
- not specified
- Type of study:
- other: review of literature and assessment of available human, animal and alternative data
- Justification for non-LLNA method:
- Study performed in 2003; when LLNA has not been an accepted OECD test method.
- Species:
- other: human volunteers
- Key result
- Reading:
- other: Not applicable as summary of several individual studies
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- Not applicable as summary of several individual studies
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No senstisation observed in studies. No sensitizing properties from experience
- Remarks on result:
- other: Summary of several individual studies
- Key result
- Reading:
- other: long experience with human exposure to the substance
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- No negative control tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not measured/tested
- Remarks on result:
- not measured/tested
- Remarks:
- No negative control exists due to a maximisation test with 25 volunteers long experience with human exposure to the substance
- Key result
- Reading:
- other: long experience with human exposure to the substance
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- No positive control tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not measured/tested
- Remarks on result:
- not measured/tested
- Remarks:
- No positive control exists due to a maximisation test with 25 volunteers and a long experience with human exposure to the substance.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Taking into account the long experience with human exposure to the substance, and the absence of any reports on contact allergy in exposed persons, methyl acetate is not expected to exhibit skin sensitizing properties, especially since the substance is hydrolysed in contact with water by non-specific tissue esterases to methanol and acetic acid. For these substances a skin sensitisation potential is either absent (methanol, Fisher, 1986) or restricted to a few cases (acetic acid, Weil and Rogers, 1951).
- Executive summary:
The result meets the long experience from human exposure to humans.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in human
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Principles of method if other than guideline:
- 10% methylacetat induction and challenge
- GLP compliance:
- not specified
- Type of study:
- other: maximization test in humans
- Justification for non-LLNA method:
- Study performed in 1979, LLNA method was not available.
- Species:
- other: human
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- In a human maximization study, 25 healthy, male (11) and (14) female subjects aged 18-31 years old were used. Test material was applied under occlusion to the same site on the volar forearm ot back of all subjects for five alternate-day 48 hour periods. The patch site was pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulfate (SLS) under occlusion. Prior to challenge, 5 to 10% SLS was applied to test site for one hour before application of test material. Challenge site was read on patch removal and 24 hours thereafter.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- no sensitisation observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- No negative control tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not measured/tested
- Remarks on result:
- not measured/tested
- Remarks:
- There is no negative control group as it is a maximisation test with 25 volunteers.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- No negative control tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not measured/tested
- Remarks on result:
- not measured/tested
- Remarks:
- There is no positive control group as it is a maximisation test with 25 volunteers.
- Interpretation of results:
- not sensitising
- Conclusions:
- The study result meets the long experience from human exposure to humans. The test method of a maximization test is justified in this case.
In this human maximization study no skin sensitisation was observed.
Referenceopen allclose all
"Total no. in group" refers to study by Kligman, only. This study is citied in EU-RAR, 2003.
The study result meets the long experience from human exposure to humans. The test method of a maximization test is justified in this case.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation, methyl acetate
Skin sensitisation, human, RL4
In a maximisation test with 25 volunteers no sensitisation was observed after exposure to 10% methyl acetate in petrolatum (Kligman, 1976). Taking into account the long experience with human exposure to the substance, and the absence of any reports on contact allergy in exposed persons, methyl acetate is not expected to exhibit skin sensitizing properties, especially since the substance is hydrolysed in contact with water by non-specific tissue esterases to methanol and acetic acid. For these substances a skin sensitisation potential is either absent (methanol, Fisher, 1986) or restricted to a few cases (acetic acid, Weil and Rogers, 1951).
Skin sensitisation, human, RL4
In the EU Risk Assessment Report on Methyl acetate (European Union Chemicals Bureau, 2003), methyl acetate was not considered to be a skin sensitiser.
Skin sensitisation, methanol
Skin sensitisation, guinea pig, RL2
In a guinea pig maximization assay, 3/10 females exhibited a slight skin response (erythema score 1) 24 h after induction and challenge with a 50% aqueous methanol solution (0.1 mL), which can be interpreted as weak sensitizing potential. In another study, using 12 female animals at a concentration of 50% methanol, 1/12 exhibited a slight skin response (erythema score 1) 24 and 48 h after challenge which can also be interpreted as a weak sensitising potential. The intracutaneous inductions produced necroses and some open ulcerations in both studies. In summary, the low number of 4/22 animals with slight erythema (score 1) gives no evidence of a notable sensitisation potential of methanol.
Conclusion:
From the overall data base and the long term experience with methyl acetate and methanol it is concluded that both source substances have no sensitisation potential. Based on a read across and following a weight of evidence approach the target substance (reaction mass of methyl acetate and methanol) is considered to be not sensitising.
Literature
Kligman AM (1976). Report to RIFM (18.05.1976). Cited in: Opdyke (1979), Food Cosmet. Toxicol. 17, 859-861.
Fisher AA (1986). Contact Dermatitis. 3rd edition. Lea & Febiger, Philadelphia 1986, p. 853 and 886.
Weil AJ, Rogers HE (1951). Allergenic reactivity to simple aliphatic acids in man. J. Invest. Dermatol. 17, 227-231.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The reaction mass of methyl acetate and methanol is assessed in a read-across approach, using the individual constituents methanol and methyl acetate. The available experimental test data for the individual substances are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data, the source substances are not considered to be skin sensitising. Using a read-across approach with the source substances methyl acetate and methyl acetate, the target substance (reaction mass of methyl acetate and methanol) is not classified as skin sensitising according to Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217.
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