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EC number: 221-698-5 | CAS number: 3195-78-6
- 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
No skin irritation was observed in rabbits. In an eye irritation study the test substance revealed an irritating potential in the rabbit eye.
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:
- 1992-04-07 to 1992-04-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reliable guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Lot/batch No.: HOE CG 0405 0A ZD00 0001
- Expiration date of the lot/batch: until November 1992 - Species:
- rabbit
- Strain:
- other: Chbb:NZW (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.0 - 3.3 kg
- Housing: individual housing
- Diet: Altromin 2123, ad libitum and hay (15 g/day)
- Water: deionisiesed, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL (treated area: 2.5 x 2.5 cm)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 min and 24,48 and 72 h and 7 days after removal of the test item.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid water
- Time after start of exposure: after 4 hours - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Interpretation of results:
- GHS criteria not met
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:
- 1992-04-28 to 1992-05-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reliable guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Lot/batch No.: HOE CG 0405 0A ZD00 0001
- Expiration date of the lot/batch: until November 1992 - Species:
- rabbit
- Strain:
- other: Chbb: NZW (SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomas GmbH, 7960 Biberach
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.1-3.5 kg
- Housing: individual housing
- Diet: Altromin 2123 ad libitum and hay (15 g/day)
- Water: deionisiesed, chlorinated water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/-20
- Photoperiod: 12 hours dark/12 hours light - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1,24, 48, 72 hours, 7 days and 14 days after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: physiological saline solution
- Time after start of exposure: 24 hours
TOOL USED TO ASSESS SCORE: fluorescein
Treated eye was examined with Fluorecein-sodium solution (0.01%) under UV light 24 hours before application and 24/72 hours after application.
Untreated eye served as control. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Other effects:
- Alopecia surrounding treated eye, eye discharge mucous
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
Key study
In a study (Hoechst AG, 1992) performed to assess the skin irritation potential of the test substance to rabbits three animals were administered a single dermal dose of 0.5 mL in a semi-occlusive application for 4 hours and observed for seven days. The skin of the rabbits revealed very slight edema scores (0, 0, 0.7) and slight erythema scores (0.7, 0.3, 2) by the mean of 24, 48, 72 h. The reactions had fully resolved by day 3-7. In conclusion, the test item is slightly irritating to the rabbit skin.
Eye
Key study
In an eye irritation study (Hoechst AG, 1992) three rabbits were administered a single ocular dose of 0.1 mL of the test substance for 24 hours and observed for 14 days after instillation. After the exposure time the eyes were washed with physiological saline solution whereby the untreated eye of each animal served as control. The treated eye was examined with Fluorecein-sodium solution (0.01%) under UV light 24 hours before application and 24/72 hours after application. The mean (24, 48, 72 h) cornea (3,2,2), iris (1,1,1), conjunctivae (2.7, 2.7, 2.7) and chemosis (3, 2.3, 2) scores for each animal showed mild to moderate eye irritating effects accompanied by alopecia surrounding treated eye and eye discharge mucous. All effects were fully reversible within 7-14 days. In conclusion, the test item is irritating to the rabbit eye.
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 1272/2008. Reversible eye irritation potential was determined. As a result the substance is considered to be classified as eye irritating Category 2 (H319: causes serious eye irritation) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
No skin irritation potential was determined. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
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