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EC number: 609-765-0 | CAS number: 39987-85-4
- 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 (rat): not irritating [Treher 1996a]
Eye irritation (rabbit): not irritating [Treher 1996b]
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Study period:
- Dec 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - time-points of evaluation were 20, 44 and 68 hours instead of 24, 48 and 72 hours after end of exposure
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 2 males and 2 females
- Executive summary:
A single dermal administration of the test substance (0.5 g applied as a paste) for 4 hours to male and female rabbits was tolerated without any local irritations. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 20, 44 and 68 hours after the end of administration were 0.
Reference
The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 20, 44 and 68 hours after the end of administration were 0.
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Study period:
- Dec 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - 4 instead of 3 animals
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Executive summary:
In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked on the whole moderate irritation on the day of treatment which gradually faded away over several days after application. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameter cornea, 0.1 for iris, 0.2 for conjunctival swelling as well as 0.5 for conjunctival reddening. According to EU classification criteria ZK 9340 need not be labelled as an eye irritant.
Reference
Table 1: Results of the study
Irritant effects (score) |
|||||
Animal no. (sex) |
Irritation parameter |
24 h | 48 h | 72 h | Mean scores |
1 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
Iris |
0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) |
1 | 0 | 0 | 0.3 | |
Conjunctiva (swelling) |
0 | 0 | 0 | 0.0 | |
2 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 0 | 0 | 0.3 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 1 | 0 | 0 | 0.3 | |
Conjunctiva (reddening) | 2 | 1 | 0 | 1.0 | |
Conjunctiva (swelling) | 2 | 0 | 0 | 0.7 | |
4 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 0 | 0 | 0.3 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 |
The control eyes were without findings.
The single application of 0.1 ml ZK 9340 (corresponding to 56.1- 62.9 mg) into the conjunctival sac of the right eye led on the application day to slight to moderate secretion, reddening of the outer eyelids and eyelid closure, one animal showing slight swelling of the outer eyelids. Slight to severe reddening and swelling of the conjunctivae was observed in all animals. Additionally, slight to moderate, in one animal severe, vascular injection was observed on the application day. Two animals showed very slight to slight reddening and slight blood vessel injection of the iris on day 1, one animal showed slight reddening of the iris until day 2. On days 2 and 3, very slight to moderate reddening and vascular injection of the conjunctivae was observed in all animals, one animal showed severe vascular injection and one showed slight swelling of the conjunctivae on day 2. These findings gradually faded away, and all animals were without findings 72 hours after application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A single dermal administration of the test substance ZK 9340 (M-DOC) according to OECD TG 404 for 4 hours to male and female rabbits was tolerated without any local irritations (Treher, 1996a). The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 20, 44 and 68 hours after the end of administration were 0 accordingto the system recommended in Directive 67/548/EEC.)
In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance ZK 9340 (M-DOC) into the conjunctival sac provoked on the whole moderate irritation on the day of treatment which gradually faded away over several days after application (Treher, 1996b). The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameter cornea, 0.1 for iris, 0.2 for conjunctival swelling as well as 0.5 for conjunctival reddening. According to EU classification criteria ZK 9340 need not be labelled as an eye irritant.
Under consideration of the molecular structure similarity of M-DOC and M-DOCA the results on skin and eye irritation of M-DOC has been accepted for M-DOCA (read-across approach).
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.
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