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EC number: 244-007-9 | CAS number: 20749-68-2
- 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
Makrolex Rot EG is not irritating to the skin nor to the mucous membranes of the eyes of rabbits
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similar to respective guideline but reported only in brief
- Principles of method if other than guideline:
- Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: oil
- Controls:
- other: the opposite side served as control
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.
- Irritation parameter:
- other: irritational effects: scarificed skin
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: irritational effects: intact skin
- Basis:
- mean
- Time point:
- other: up to 7 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- 72 hours post application, only the scarificed area of both rabbits showed a marked reddening of the skin (scores not given) which were fully reversible within 7 days. No other irritating effects were observed
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Single application of 500 mg Macrolex Rot EG moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days. 72 hours post application , omly the scarificed area of both rabbits showed a marked reddening of the skin (score 2/4) which were fully reversible within 7 days. Intact skin showed no reaction. Therefore, Macrolex Rot EG is evaluated as non-irritant to the intact skin of rabbits
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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similar to respective guideline but reported only in brief
- Principles of method if other than guideline:
- 100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- one left eye : due to rinsing: 1 min, the other left eye was not rinsed
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- 100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days.
- Irritation parameter:
- other: irritational effects
- Basis:
- mean
- Time point:
- other: up to 8h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: slight conjunctival injections which do not lead to classification
- Irritant / corrosive response data:
- After 4 hours and after 8 hours slight conjunctival injections and slight discharge was observed. Within 24 hours both left treated eyes cleared and dis charge ceased wether it was rinsed eye or not-rinsed eye. Fluorescein test was without finding.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days. Four hours and 8 hours post application slight irritating effects were observed which were fully reversible within 24 hours, thus, not leading to classification. In addition, Fluorescein Test was without finding. Therefore, the overall evaluation is that Macrolex Rot is not irritating to the eyes of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
SKIN IRRITATION
Single application of 500 mg Macrolex Rot EG moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days. 72 hours post application , omly the scarificed area of both rabbits showed a marked reddening of the skin (scores not given) which were fully reversible within 7 days. No other irritating effects were observed. Therefore, Macrolex Rot EG is evaluated as non-irritant to the intact skin of rabbits
EYE IRRITATION
100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days. Four hours and 8 hours post application slight irritating effects were observed which were fully reversible within 24 hours, thus, not leading to classification. In addition, Fluorescein Test was without finding. Therefore, the overall evaluation is that Macrolex Rot is not irritatin to the eyes of rabbits.
Justification for selection of skin irritation / corrosion endpoint:
This is the only availble study
Justification for selection of eye irritation endpoint:
this is the only available study
Justification for classification or non-classification
Based on the available data no classification or labelling is required.
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