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EC number: 210-940-5 | CAS number: 626-27-7
- 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 [Kurth 2006]
Eye irritation (rabbit): not irritating [Amir 2005]
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:
- Aug 2002 to Feb 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - exposure time 24 hrs instead of 4 hrs, few details in test description and reporting
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 276-313 g (males), 188-193 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 54-62 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 0.64-0.67 mL / male animal or 0.40 -0.42 mL / female animal (= 2000 mg/kg bw)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- Skin areas were assessed 1, 24, 48 and 72 hours after the end of administration. Evaluation of skin reactions(reddening, scab formation and swelling of the skin) was done according to the system recommended in Directive 67/548/EEC.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.95
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight to slight skin reddening was noted in all animals treated with 2000 mg/kg bw. In addition, desquamation was observed in all female animals and in two male animals. The local intolerance reactions observed in rats were reversible within 11 days after administration. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0 for swelling and 0.95 for reddening and scab formation (see table 1).
- Interpretation of results:
- other: slight local intolerance reactions noted up to day 8.
- Executive summary:
A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg (0.64-0.67 mL / male or 0.40 -0.42 mL / female) led to slight local intolerance reactions up to day 8 after administration. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0 for swelling and 0.95 for reddening and scab formation.
Reference
Table 1: Mean values of findings relevant for classification.
Test compound ZK 56406 (2000 gm/kg) |
Animal number and sex |
||||||
Location (finding) |
Time-point after end of exposure |
10M |
11M |
12M |
4F |
5F |
6F |
Reddening and scab formation |
1 hour* |
0 |
0 |
2 |
2 |
2 |
2 |
24/25 hours |
1 |
0 |
1 |
2 |
2 |
2 |
|
48 hours |
1 |
0 |
1 |
2 |
1 |
1 |
|
72 hours |
0 |
0 |
1 |
1 |
1 |
0 |
|
Individual mean values: |
0.67 |
0 |
1.0 |
1.67 |
1.33 |
1.0 |
|
Mean value of all animals: |
0.95 |
||||||
|
|||||||
Swellings |
1 hour* |
0 |
0 |
0 |
0 |
0 |
0 |
24/48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
Individual mean values: |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean values of all animals: |
0 |
M = male
F = female
* = not included in calculations of mean values
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:
- Aug to Sep 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Weight at study initiation: 2.7-2.9 kg (males), 2.6 kg (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 56-62 %
- Photoperiod (hrs dark / hrs light): 12/12 - 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):
- 10 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Details on study design:
- 0.1 mL correspond to ca. 93 mg test substance
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- other: slight to moderate irritation (fully reversible by day 10)
- 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 slight to moderate irritation on the day of administration which decreased in severity from day 2 onwards and were fully reversible on day 10 after administration. 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, 0.08 for iris, 1.17 for conjunctival swelling and 1.0 for conjunctival reddening. According to EU classification criteria ZK 56406 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 | 1 | 1 | 1.0 | |
Conjunctiva (swelling) |
1 | 1 | 1 | 1.0 | |
2 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 1 | 1 | 1.0 | |
Conjunctiva (swelling) | 1 | 1 | 1 | 1.0 | |
3 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 1 | 0 | 0 | 0.33 | |
Conjunctiva (reddening) | 1 | 1 | 1 | 1.0 | |
Conjunctiva (swelling) | 2 | 2 | 1 | 1.67 | |
4 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 1 | 1 | 1 | 1.0 | |
Conjunctiva (swelling) | 1 | 1 | 1 | 1.0 |
The control eyes were without findings.
The single application of 0.1 mL ZK 56406 into the conjunctival sac of the right eye led to slight to moderate reddening and swelling of the conjunctivae in most of the animals from administration day one up to day 6. In one female animal reddening was seen up to day 7 and in one male animal up to day 9, respectively. In one male and in one female animal swelling of the conjunctivae appeared up to day 7 of the test. Vessel injection of the iris was seen in one female animal 24 hours after instillation. All animals were without findings on day 10.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A combined study on acute dermal toxicity and on local tolerance was conducted (Kurth, 2006). The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. In this study a single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg (0.64-0.67 mL / male or 0.40 -0.42 mL / female) led to slight local intolerance reactions up to day 8 after administration. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0 for swelling and 0.95 for reddening and scab formation according to the system recommended in Directive 67/548/EEC.
In addition, a single dermal administration of 0.25 mL ZK 56406 for up to 4 hours to female rabbits revealed slight to moderate local intolerance reactions in form of erythema, swelling, desquamation and wrinkling. In no case necrosis were observed (Schöbel, 1982).
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 slight to moderate irritation on the day of administration which decreased in severity from day 2 onwards and were fully reversible on day 10 after administration (Amir, 2005). 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, 0.08 for iris, 1.17 for conjunctival swelling and 1.0 for conjunctival reddening. According to EU classification criteria ZK 56406 need not be labelled as an eye irritant.
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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