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Registration Dossier
Diss Factsheets
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EC number: 201-346-7 | CAS number: 81-39-0
- 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
Skin irritation in vivo:
0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize. No irritation (scores 0) was observed on the intact and scarificed skin at any time point.
Eye irritation in vivo:
100 mg test item was applied to the eye of a rabbit and animals were imnvestigated after 24, 48 and 72 h. Cornea, iris, conjunctivae and secretion observations were scored according to Draize. No effects (scores 0) were reported for all endpoints and all time points.
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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- No guideline followed but method is comparable to OECD TG 404 in principle.
- Deviations:
- yes
- Remarks:
- No guideline followed but method is comparable to OECD TG 404 in principle.
- Principles of method if other than guideline:
- 0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Macrolex Rot 5B
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Body weight between 2.3 and 2.8 kg; 6 male and 6 female rabbits.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml test item (50% test item 50% water)
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 days
- Number of animals:
- 6 male and 6 female
- Details on study design:
- 0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Other effects:
- no effect on clinical observations, feed intake, body weight development
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No adverse effects observed. Not irritating.
- Executive summary:
0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize. No irritation was observed on the intact and scarificed skin at any time point.
Reference
No irritation was observed on the intact and scarificed skin at any time point.
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
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- No guideline followed but method is comparable to OECD TG 405 in principle.
- Deviations:
- not applicable
- Remarks:
- No guideline followed but method is comparable to OECD TG 405 in principle.
- Principles of method if other than guideline:
- 100 mg test item was applied to the eye of a rabbit and animals were imnvestigated after 24, 48 and 72 h. After 24 h fluorescein test was also performed. The cornea, iris, conjunctivae and secretion observations were scored according to Draize
- GLP compliance:
- no
- Specific details on test material used for the study:
- Macrolexrot 5B
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Body weight between 2.3 and 2.8 kg; 6 rabbits.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 6 rabbits
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- No effects (scores 0) were reported for all time points.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- No effects (scores 0) were reported for all time points.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- No effects (scores 0) were reported for all time points.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- No effects (scores 0) were reported for all time points.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- No effects (scores 0) were reported for all time points.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No adverse effects observed. Not irritating.
- Executive summary:
100 mg test item was applied to the eye of a rabbit and animals were investigated after 24, 48 and 72 h. The cornea, iris, conjunctivae and secretion observations were scored according to Draize. No effects (scores 0) were reported for all endpoints and all time points.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No irritation (scores 0) were reported in early in vivo skin and eye irritation studies in rabbits. Classification is not warranted.
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