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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 irritation
Methyl acetate
In an in vivo skin irritation study according to OECD guideline 404, no skin irritating properties were observed for methyl acetate in rabbits.
Methanol
In an in vivo skin irritation study according to internal company standards (Klimisch score 2), methanol was found to be not irritating to skin.
Eye irritation
Methyl acetate
In an in vivo eye irritation study according to OECD guideline 405, eye irritation was observed for methyl acetate in rabbits. Methyl acetate was thus classified as eye irritant, category 2.
Methanol
In an in vivo eye irritation study according to internal company standards (Klimisch score 2), methanol induced mild to moderate eye irritation in rabbits which was fully reversible within 8 days. In another study in rabbits, application of 0.1 mL undiluted methanol resulted in mild to moderate conjunctivitis and edemas as well as mild iritis which was mainly reversible after 72 hours.
Conclusion
Based on the results of skin and eye irritation studies with the two source substances methyl acetate and methanol, skin or eye irritating properties of of the reaction mass of methyl acetate and methanol is assessed. Following a worst scenario, methyl acetate, the more critical of both substances, is used for assessment. Therefore, the reaction mass of methyl acetate and methanol is not considered a skin but an eye irritant (category 2).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.02.1988 - 05.02.1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- QAU statement available
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: Ca. 3 - 5 months
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: In fully conditioned rooms in single cages (batteries)
- Diet: Altromin 2123 posture diet- rabbit, ad libitum plus hay (ca. 15 g per day)
- Water: Deionised and dechlorinised water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod: 12 hours dark / 12 hours light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- Exposure period: 4 hours
- Observation period:
- 30 and 60 minutes, 24, 48 and 72 hours after tape removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm² of the shaved dorsal skin
- Type of wrap: Exposed area was covered with a semiokklusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: Treated skin was washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to the guideline - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Other effects:
- 24, 48, and 72 hours after patch removal, dry skin was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, methyl acetate is not irritating to the skin and does not require labelling according to the dangerous substance directive.
- Executive summary:
Methyl acetate was applied to the rabbit's skin. 0.5 mL of the test item was applied undiluted on the skin and covered with a patch for 4 hours. Effects were examined after 30 and 60 minutes, as well as after 24, 48 and 72 hours after patch removal. Only slight erytheme were observed after 30 -60 minutes as well as 24 hours after patch removal. Based on the results, methyl acetate can be considered as not irritant to skin and does not require labelling.
In-vitro testing for skin corrosion and skin irritation is not required.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Study performed according to internal company standards (BASF-test) before actual guideline was adopted.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Unspecified amount
- Concentration: 100 % (undiluted) - Duration of treatment / exposure:
- 1, 5, 15 min and 20 hours (ear: only 20 hours)
- Observation period:
- 24, 48, 72 hours, 6 days and 8 days after beginning of application (exception: application time 20 hours: no observations after 24 hours)
- Number of animals:
- 2 (1, 5 and 15 min); 2 (20 hours)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm area of skin on the back and the ear
- % coverage: Not specified (application site 2.5 x 2.5 cm)
- Type of wrap: Cotton pad soaked with the undiluted test substance, covered by an impervious bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water, sometimes containing a mild detergent
- Time after start of exposure: 1, 5, 15 min, 20 hours (after the application)
SCORING SYSTEM: BASF scoring system, convertible to Draize - Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- No individual animal scores given in the report.
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- No individual animal scores given in the report.
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- No individual animal scores given in the report.
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- After 1, 5, 15 min of exposure, no signs of irritation (erythema, edema) were apparent as well as after 24, 48 and 72 hours and after 6 and 8 days.
- Other effects:
- No mortality occurred. There were no clinical signs of systemic toxicity from the dermal exposure.
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility | Erythema | Edema |
Max. score: 1 | Max. score: 0 | |
30-60 min | 1/1/1 | 0/0/0 |
24 h | 0/1/1 | 0/0/0 |
48 h | 0/0/0 | 0/0/0 |
72 h | 0/0/0 | 0/0/0 |
Average 24h, 48h, 72h | 0.0/0.3/0.2 | 0/0/0 |
Reversibility*) | c | c |
Average time (unit) for reversion | 48 hours | 48 hours |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
No individual animal scores given in the report.
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:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes of the same animals served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Undiluted - Duration of treatment / exposure:
- unspecified (not rinsed, guideline study)
- Observation period (in vivo):
- 1, 4, 24, 48, 72 hours, 8 and 14 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not rinsed (guideline study)
SCORING SYSTEM: OECD Draize
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 2.06
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 2.06
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 - 6
- Time point:
- 24/48/72 h
- Score:
- 2.06
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1 - 6
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1 - 6
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 - 6
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Other effects:
- not reported
- Interpretation of results:
- not irritating
- Conclusions:
- The mean scores of the single symptoms did not exceed the respective limits for classification: therefore, this result can be interpreted in terms of a mild irritation potential not requiring classification as eye irritating.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 09.02.1988 - 16.02.1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- QAU statement available
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: Ca. 3 - 5 months
- Weight at study initiation: 2.1 - 2.6 kg
- Housing: In fully conditioned rooms in single cages (batteries)
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum plus hay
- Water: Deionised and dechloronosed water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod: 12 hours dark / 12 hours light - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL applied into the left eye
- Concentration: Pure test substance - Duration of treatment / exposure:
- evaluation after 1, 24, 48 and 72 hours after application
- Observation period (in vivo):
- 3 days plus an additional examination after 7 days
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes were washed with a sodium chloride solution on each examination date
- Time after start of exposure: 24 hours after application and on each examination date if the treates eyes still showed secretion
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Remarks:
- After 24 and 48 hours, the conjunctivae of the animals showed white discoloration, bleedings and partly ablations.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Remarks:
- After 24 and 48 hours, the conjunctivae of the animals showed white discoloration, bleedings and partly ablations.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Remarks:
- After 24 and 48 hours, the conjunctivae of the animals showed white discoloration, bleedings and partly ablations.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after application
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results, methyl acetate is classified as irritant and has to be labelled with R36 (irritant to eyes).
- Executive summary:
Methyl acetate was applied to the rabbit's eye.The test concentration was 0.1 mL test substance per eye. Effects were examined after 1, 24, 48 and 72 hours after application. Due to the fact that effects were still observed 72 hours after application, an additional examination took place 7 days after application. At this time point, no effects were observed anymore. Based on the results, methyl acetate has to be classified as irritant to eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- limited documentation
- Principles of method if other than guideline:
- Study performed according to internal company standards (BASF-test) before actual guideline was adopted.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: saline-treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.05 mL
- Concentration: 100 % - Duration of treatment / exposure:
- unspecified (not rinsed)
- Observation period (in vivo):
- 1 hour, 24 hours, 8 days (no further time points reported)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not rinsed
SCORING SYSTEM: BASF-code, convertible to DRAIZE
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- iris score
- Remarks:
- No iris score given.
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no iris score measured
- Remarks on result:
- no indication of irritation
- Remarks:
- no iris score measured
- Irritation parameter:
- iris score
- Remarks:
- No iris score given.
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no iris score measured
- Remarks on result:
- no indication of irritation
- Remarks:
- no iris score measured
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Remarks:
- only 24 h time point measured
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Remarks:
- only 24 h time point measured
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Remarks:
- only 24 h time point measured
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Remarks:
- only 24 h time point measured
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Remarks:
- only 24 h time point measured
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- No individual animal scores available.
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Remarks:
- only 24 h time point measured
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Remarks:
- only 24 h time point measured
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- After 1 h, mild erythema and cornea opacity as well as moderate edema associated with secretion were observed. After 24 h, the effects were assessed as mild. After 8 days the animals were without symptoms.
- Interpretation of results:
- not irritating
Referenceopen allclose all
Irritation scores as reported:
|
Mean Scores |
||||
|
Time after application [h] |
||||
|
1 |
4 |
24 |
48 |
72 |
Conjunctivitis |
0.89 |
2.00 |
1.67 |
2.28 |
2.22 |
Chemosis |
2.00 |
2.00 |
0.67 |
1.00 |
0.50 |
Iritis |
0.33 |
1.00 |
1.00 |
1.00 |
0.33 |
Corneal opacity |
0.00 |
0.00 |
0.50 |
0.50 |
0.67 |
Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 1 |
Max. score: 1 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
1/1/1 |
1/1/1 |
2/2/1 |
4/4/3 |
24 h |
1/1/1 |
1/1/1 |
3/3/3 |
2/3/3 |
48 h |
1/2/1 |
1/1/1 |
3/2/3 |
2/1/2 |
72 h |
1/2/2 |
1/1/1 |
2/2/3 |
1/1/1 |
Average 24h, 48h, 72h |
1.3 |
1.0 |
2.7 |
1.8 |
Maximum average score |
1.7 |
1.0 |
3.0 |
2.0 |
Reversibility*) |
c |
c |
c |
c |
Average time (unit) for reversion |
7 days |
7 days |
7 days |
7 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
This screening test gave evidence of mild to moderate irritation of the mucous membrane on contact with pure methanol, which was fully reversible within 8 days. Therefore, there was no need for classification as eye irritating.
Exposure to an atmosphere saturated by methanol vapours at 20°C produced severe irritation of mucous membranes and milky corneal opacity in rats (time not specified) and eventually led to mortality of all animals within 8 h.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Irritation/corrosion, methyl acetate
Skin irritation (rabbit), RL1
Methyl acetate was tested according to OECD Guideline 404 for its skin irritation potential. 0.5 mL of the test item were applied undiluted on the skin of the rabbits and covered with a patch for 4 hours. Effects were examined after 30 and 60 minutes, as well as after 24, 48 and 72 hours after patch removal. Only slight erythema were observed after 30 -60 minutes as well as 24 hours after patch removal. Based on the results, methyl acetate can be considered as not irritant to skin. (Kreilling und Jung, 1988).
Skin irritation (human), RL4
Application of 2 drops of methyl acetate to human skin caused cooling and desquamation but no irritation (von Oettingen, 1960). No further more data are available. Exposure to the vapours for 5 minutes leads to irritation of the eyes, nose, throat and trachea from approximately 15 mg/l (Reus, 1933, cited by BG Chemie, 1995).
Methyl acetate has proven to cause only weak skin irritation in humans and in rabbits (no oedema, erythema with maximum grade 1 reversible within 48 hours) and not requiring classification.
Eye Irritation (rabbit), RL1
Methyl acetate was examined for its eye irritation potential according to OECD Guideline 405 by application to the rabbit's eye. The test concentration was 0.1 ml test substance per eye (Kreilling und Jung, 1988). Effects were examined after 1, 24, 48 and 72 hours after application. Due to the fact that effects were still observed 72 hours after application, an additional examination took place 7 days after application. At this time point, no effects were observed anymore. Based on the results, methyl acetate has to be classified as irritant to eyes.
The maximum average score was 1.7 for the cornea, 1.0 for the iris, 3.0 for the conjunctivae and 2.0 for chemosis. There was a complete reversibility within 7 days for all 4 responses.
Respiratory Irritation
In ECHA disseminated dossiers, a RD50 of 829 ppm for mice was reported for respiratory irritation by Muller and Greff (1984), citied in EU RAR for methyl acetate.
Conclusion: Methyl acetate has proven to cause only weak skin irritation in humans and in rabbits (no oedema, erythema with maximum grade 1 reversible within 48 hours). Skin corrosion was not reported. These results were obtained from in vivo studies. An acute toxicity study by the dermal route did not indicate skin corrosion up to the limit dose level of 2000 mg/kg bw. Methyl acetate is classified as irritating to eyes. Hence, in-vitro testing on skin irritation and skin corrosion is not required according to Annex VII 8.1 column 2, bullet points 1 and 4. Methyl acetate is irritating to eyes and consequently has been classified as R 36 ("irritating to eyes") or Eye Irrit. 2 "H319: Causes serious eye irritation", resp. Hence, in-vitro testing on eye irritation is not required according to Annex VII 8.2 column 2, bullet point 1.
Literature:
von Oettingen WF (1960). The aliphatic acids and their esters: Toxicity and potential dangers. The saturated monobasic aliphatic acids and their esters. Arch. Ind. Health 21, 28-65.
Muller J, Greff G (1984). Recherche de relations entre toxicité de molécules d’intérêt industriel et proprieties physico-chimiques: Test d’irritation des voies aeriennes supérieures appliqué à quatre familles chimiques. Fd. Chem. Toxicol. 22, 661-664.
Irritation/corrosion, methanol
Skin irritation (rabbit), RL2
The irritation potential of an unspecified dose of undiluted methanol in rabbits was examined under occlusive conditions after exposure intervals of 1, 5, and 15 minutes and 20 hours. According to Draize scoring, no signs of skin irritation were observed 24 hours and 8 days after treatment for any of the exposure time periods (BASF, 1975).
Eye irritation (rabbit), RL2
One hour after instillation of 0.05 mL undiluted methanol into the eyes of two rabbits, slight erythemas and corneal opacity as well as moderate edemas associated with secretion were observed. After 24 hours, the effects were assessed as mild, and after 8 days the animals had no symptoms (BASF, 1975).
Eye irritation (rabbit), RL2
In another study, mild to moderate conjunctivitis and edemas as well as mild iritis were produced in six rabbits after instillation of 0.1 mL undiluted methanol into the eyes. Average scores after 24, 48, and 72 hours were approximately 2 for conjunctivae and < 1 for other effects. Primary irritation subsided after 72 hours, although redness of the conjunctivae persisted at that time. Information on effects after 8 and 14 days was not available (Jacobs, 1990).
Conclusion
Based on the results of skin and eye irritation studies with the two source substances methyl acetate and methanol, the skin or eye irritation potential of the reaction mass of methyl acetate and methanol is assessed. Following a worst scenario, methyl acetate, the more critical of both substances, is used for assessment. Therefore, the reaction mass of methyl acetate and methanol is considered as an eye irritant.
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 on the basis of the individual constituents methyl acetate and methanol using a read-across approach. The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Following a worst scenario, methyl acetate, the more critical of both substances, is used for the classification. The test item is not considered to be classified for skin irritation/corrosion but for eye irritation (category 2) according to EU Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217.
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.
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