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EC number: 240-162-1 | CAS number: 16024-58-1
- 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: The test substance was found to be not irritating to skin.
Eye irritation: The test substance was found to cause serious eye damage.
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:
- 1990-11-27 to 1990-11-30
- 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:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- 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: HOECHST AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: single
- Diet: ad libitum, Altromin 2123
- Water: ad libitum, deionized water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- readings were conducted 30-60 min, 24, 48 and 72 h after removal of the test substance
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal, appr. 25 cm^2
- Type of wrap: cellulose patch covered by a semiocclusive patch
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with lukewarm tap water
- Time after start of exposure: directly after removal of the patch ( 4h)
OBSERVATION TIME POINTS
30-60 min, 24, 48 and 72 h
SCORING SYSTEM:
5 graded scale - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were detected.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not irritating to skin in this in vivo study.
- Executive summary:
0.5 mL of the undiluted test material was applied to the clipped skin of three New Zealand White rabbits for 4 hours under semiocclusive dressing. After removal of the patches the test sites were washed with lukewarm water. Skin findings were scored 30-60 min, 24 h, 48 h and 72 h after removal of the test substance. As a result, no signs of irritation (edema oder erythema) were found on the tested skin sites. Therefore it was concluded that the tested substance is not irritating to skin.
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:
- 1990-12-04 to 1990-12-18
- 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
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.52 kg
- Housing: individual
- Diet: Altromin 2123 ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 /12- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- one treatment, after 24 hours the eye was washed
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to Draize
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- In the treated eye the animal exhibited a difuse reddening of the conjunctiva and swellings, eyelids were more than half closed. Opactity of the cornea was observed, from the 7th day onwards no light reaction of the iris was observed any more. White discharge, whitish conjunctiva and ablation as well as bleeding of parts of the conjunctiva was observed. 14 days after treatment the cornea showed vascularisation and an uneven surface.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item is considered to cause serious eye damage in the rabbits' eye and classified into category 1.
- Executive summary:
The acute eye irritation study of the test item was performed in one New Zealand White rabbit according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of the animal. The untreated right eye served as control. The treated eye of the test animal was washed out 24 hours after application. The eye was examined at 1, 24, 48, and 72 hours after the application. In the treated eye the animal exhibited a difuse reddening of the conjunctiva and swellings, eyelids were more than halfly closed. Opactity of the cornea was observed, from the 7th day onwards no light reaction of the iris was observed any more. White discharge, whitish conjunctiva and ablation as well as bleeding of parts of the conjunctiva was observed. 14 days after treatment the cornea showed vascularisation and an uneven surface. Based on these findings the test item was considered to cause serious eye damage and classified into category 1.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
0.5 mL of the undiluted test material was applied to the clipped skin of three New Zealand White rabbits for 4 hours under semiocclusive dressing. After removal of the patches the test sites were washed with lukewarm water. Skin findings were scored 30-60 min, 24 h, 48 h and 72 h after removal of the test substance. As a result, no signs of irritation (edema oder erythema) were found on the tested skin sites. Therefore it was concluded that the tested substance is not irritating to skin.
Eye irritation:
The acute eye irritation study of the test item was performed in one New Zealand White rabbit according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of the animal. The untreated right eye served as control. The treated eye of the test animal was washed out 24 hours after application. The eye was examined at 1, 24, 48, and 72 hours after the application. In the treated eye the animal exhibited a difuse reddening of the conjunctiva and swellings, eyelids were more than halfly closed. Opactity of the cornea was observed, from the 7th day onwards no light reaction of the iris was observed any more. White discharge, whitish conjunctiva and ablation as well as bleeding of parts of the conjunctiva was observed. 14 days after treatment the cornea showed vascularisation and an uneven surface. Based on these findings the test item was considered to cause serious eye damage and classified into category 1.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) 1272/2008 (CLP). As a result the substance is not considered to be classified for skin irritation but classified for eye irritation into category 1 (H318: causes serious eye damage) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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