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EC number: 603-006-7 | CAS number: 124728-62-7
- 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: No skin irritating potential could be detected for the read-across source substance.
Eye irritation: The test item showed no irritating effects in the HET-CAM test.
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:
- March 23, 2007 - July 13, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Official Journal of the European Communities L383 A, Vol. 15, 29. December 1992.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 15 weeks
- Weight at study initiation: 3.14 - 3.35 kg
- Housing: separately in special rabbit cages (manufacturer: Becker, type K99/30 KU)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 19
- Humidity (%): 45 - 53
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 8 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g per animal
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Before application, the test material was mixed with some drops of Aqua pro injectione and ground in a mortar using a pestle.
VEHICLE
Name: Aqua pro injectione
Manufacturer: Merck KGaA, Darmstadt
Batch: 189
Released until: June 08, 2009 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: left side of the animal back
- Type of wrap if used: self-adhesive fabric (Fixomull stretch, Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Method: wiped off
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour after removal, after 24, 48, 72 hours, and then daily up to experimental day 8
SCORING SYSTEM:
- Method of calculation: according to OECD 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritating potential could be detected.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected for the test item.
- Executive summary:
A study was performed according to GLP and methods applied were fully compliant with OECD 404. The test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards, the test material was spread onto patches and applied to the intact skin of previously shaven rabbits for 4 hours under semi-occlusive conditions. The study was performed initially with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin followed 1 hour after patch removal. Thereafter, examinations were performed daily for a further 7 days. Under the conditions of the present study, no signs of irritation were seen. Body weight development of the treated rabbits was inconspicuous. Thus, no skin irritating potential could be detected for the test item.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD 404. A detailed read-across justification is provided in chapter 13 of this dossier.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-09-24 to 2007-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: Hen's egg test on the chorioallantoic membrane (HET-CAM) for irritating potential
- Version / remarks:
- according to Lüpke (Fd. Chem. Tox. 1985; 23 (2):287-291), with modifications described by Kalweit (Toxic. in vitro 1990; 4 (4/5):702-706)
- Principles of method if other than guideline:
- During the second part of the 1980's, with a growing number of chemicals to be tested and due to an increasing awareness towards the need to protect animals from painful experiments, the hen's egg chorioallantoic membrane test (HET-CAM) was developed. The chorioallantoic membrane (CAM) of fertilized and incubated hen eggs provides a suitable model for membranes with an intact and functional vascular system. The CAM has no nerve fibers in the early stages of development and is regarded as being insensitive to pain. For these reasons, the HET-CAM is believed to be a reliable alternative to the primary eye irritation test in rabbits, which does not conflict with ethical and legal aspects of animal protection.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: hen's eggs, fertilized
- Strain:
- other: White leghorn
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
-Source: LSL Rhein Main Geflügelvermehrungsbetrieb, Dieburg, Germany - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- The tip of a spatula of the test item was applied on the vascular chorioallantoic membrane (CAM). The application volume of the reference material was 0.3 mL.
- Duration of treatment / exposure:
- Only eggs without injuries of the membrane or other abnormalities were used for testing. After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (haemorrhage, lysis, and coagulation) over a period of 300 sec. The period between treatment and the onset of the reactions was measured in seconds and recorded with stopwatch and protocol.
- Number of animals or in vitro replicates:
- 6 eggs were used
- Details on study design:
- The irritating potential of the test item was determined in the hen's egg test on the chorioallantoic membrane (HET-CAM). Fertile hen eggs on day 10 of incubation provided the test system. The eggshell was removed around the air cell by means of a dentist drill and the shell with attached outer membrane and inner egg membrane was carefully opened. After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the chorioallantoic membrane (CAM) of the fertilized eggs, which lies immediately below. After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (haemorrhage, lysis, and coagulation) over a period of 300 sec. As reference material dodecyl sulfate sodium salt was tested and evaluated to ensure the sensitivity of the system.
Scoring system according to: Lüpke, NP (1985) Hen's egg chorioallantoic membrane test for irritation potential. Fd. Chem. Toxic. 23 (2), 287-291.
Cumulative score Assessment of irritancy
0 – 0.9 None
1 – 4.9 Mild
5 - 8.9 Moderate
9 - 21 Severe - Irritation parameter:
- in vitro irritation score
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- Score: 9.69
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no irritating effects in the HET-CAM test.
- Executive summary:
The irritating potential of the test item was determined in the hen's egg test on the chorioallantoic membrane (HET-CAM). This test is routinely used as a screening assay prior to in vivo tests in rabbits for eye irritation. Fertile hen eggs on day 10 of incubation provided the test system. The eggshell was removed around the air cell by means of a dentist drill. The shell with attached outer membrane and inner egg membrane was carefully opened. After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the chorioallantoic membrane (CAM) of the fertilized eggs, which lies immediately below. After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (haemorrhage, lysis, and coagulation) over a period of 300 sec. As reference material dodecyl sulfate sodium salt was tested and evaluated to ensure the sensitivity of the system. For the test item a cumulative score of 0 (no irritancy) was obtained, while dodecyl sulfate sodium salt as reference material gave a score of 9.69 (severe irritancy). Under the given experimental conditions, the test item showed no irritating effects in the HET-CAM test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
No study data with the test item is available for this endpoint. Therefore, a read-across to the read-across source substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the endpoint for the test item.
A study was performed according to GLP and methods applied were fully compliant with OECD 404. The test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards, the test material was spread onto patches and applied to the intact skin of previously shaven rabbits for 4 hours under semi-occlusive conditions. The study was performed initially with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin followed 1 hour after patch removal. Thereafter, examinations were performed daily for a further 7 days. Under the conditions of the present study, no signs of irritation were seen. Body weight development of the treated rabbits was inconspicuous. Thus, no skin irritating potential could be detected for the test item.
Eye irritation
The irritating potential of the test item was determined in the hen's egg test on the chorioallantoic membrane (HET-CAM). This test is routinely used as a screening assay prior to in vivo tests in rabbits for eye irritation. Fertile hen eggs on day 10 of incubation provided the test system. The eggshell was removed around the air cell by means of a dentist drill. The shell with attached outer membrane and inner egg membrane was carefully opened. After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the chorioallantoic membrane (CAM) of the fertilized eggs, which lies immediately below. After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (haemorrhage, lysis, and coagulation) over a period of 300 sec. As reference material dodecyl sulfate sodium salt was tested and evaluated to ensure the sensitivity of the system. For the test item a cumulative score of 0 (no irritancy) was obtained, while dodecyl sulfate sodium salt as reference material gave a score of 9.69 (severe irritancy). Under the given experimental conditions, the test item showed no irritating effects in the HET-CAM test.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation, the test item does not require classification for skin and eye irritation according to Regulation (EC) No 1272/2008 (CLP).
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