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EC number: 606-682-1 | CAS number: 2098-65-9
- 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 (Rabbit-NZW, GLP, comparable to OECD TG 404): no evaluation possible [Schering AG, Report -draft-, 1994-04-27]
Skin irritation in vivo (Rat, GLP): not irritating to the skin [Schering AG, Report No. X110 -draft-, 1996-08-06]
Eye irritation in vivo (Rabbit-NZW, GLP, OECD TG 405): not irritating to the eye [Schering AG, Report No. X136 -draft-, 1996-08-23]
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:
- November to December 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Principles of method if other than guideline:
- combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.3 ml) to male and female rats; occlusive exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained immediately after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Type of coverage:
- occlusive
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- for local effects 72 hours, whole study 14 days
- Number of animals:
- 3/sex
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No mortalities occurred and no compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item revealed no skin irritating properties
- Executive summary:
The single dermal administration of the test substance (ZK 12126) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. Moreover, no local intolerance reactions at the application sites were observed. The mean values of findings relevant for dermal classification (reddening, scab formation and swelling of the skin) at the time-points immediately after removal of the bandage and the substance, 24, 48 and 72 h after the end of administration were 0.
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
- Study period:
- February 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Controls:
- other: left eye served as control
- Duration of treatment / exposure:
- test substance remained in the eye, eye was not rinsed
- Observation period (in vivo):
- 5 d
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The single administration of 1,2 -Methylen-4,6 -dien into the right eye of 2 male and 2 female rabbits with a volume of 0.1 ml/eye (corresponding to 50.3 -56.4 mg) resulted in slight secretion, swelling and reddening of the outer eye lids as weil as eye lid closure and to moderate to severe reddening, swelling and blood vessel injection of the conjunctivae mainly on the application day. These effects gradually subsided and from day 3 (2 animals), 4 or 5 onwards, all animals were without findings.
According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea and iris, 0.3 for conjuntival swelling and 0.8 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Reference
Results of the study after 24, 48 and 72 h:
Irritant Effects (Score) | |||||||
Animal | 24 h | 48 h | 72 h | Mean scores | |||
1 (M) | Cornea | 0 | 0 | 0 | 0.0 | ||
Iris | 0 | 0 | 0 | 0.0 | |||
Conjunctivae (reddening) | 1 | 0 | 0 | 0.33 | |||
Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |||
2 (M) | Cornea | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0.0 | |||
Conjunctivae (reddening) | 2 | 1 | 1 | 1.33 | |||
Conjunctivae (swelling) | 2 | 1 | 0 | 1.0 | |||
1 (F) | Cornea | 0 | 0 | 0 | 0.0 | ||
Iris | 0 | 0 | 0 | 0.0 | |||
Conjunctivae (reddening) | 2 | 1 | 0 | 1.0 | |||
Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |||
2 (F) | Cornea | 0 | 0 | 0 | 0.0 | ||
Iris | 0 | 0 | 0 | 0.0 | |||
Conjunctivae (reddening) | 1 | 0 | 0 | 0.33 | |||
Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 |
A single application of 0.1 ml ZK 12126 into the conjunctival sac of the rabbit eye led to slight secretion, swelling and reddening of the outer eye lids as weil as eye lid closure and to moderate to severe reddening, swelling and blood vessel injection of the conjunctivae mainly on the application day. These effects gradually subsided and from day 3 (2 animals), 4 or 5 onwards, all animals were without findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a dermal study in rats a single dermal administration of 1,2 -Methylene-4,6 -dien to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit 1,2 -Methylene-4,6 -dien can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) under occlusive conditions (instead of semiocclusive conditions) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.
The single administration of 1,2 -Methylen-4,6 -dien into the right eye of 2 male and 2 female rabbits with a volume of 0.1 ml/eye (corresponding to 50.3 -56.4 mg) resulted in slight secretion, swelling and reddening of the outer eye lids as weil as eye lid closure and to moderate to severe reddening, swelling and blood vessel injection of the conjunctivae mainly on the application day. These effects gradually subsided and from day 3 (2 animals), 4 or 5 onwards, all animals were without findings.
According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea and iris, 0.3 for conjuntival swelling and 0.8 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Justification for classification or non-classification
Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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