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EC number: 209-798-7 | CAS number: 593-56-6
- 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 reliable data are available for the test substance. The toxicological assessment is based on read-across to CAS 10039-54-0 (skin irritation) and CAS 5470-11-1 (eye irritation)
Irritation:
- skin: mild irritant (according to CLP Regulation); rabbit 20h, occlusive (Draize test similar to OECD TG 404, non-GLP, reliability 2)
- eye: corrosive; rabbit (similar to OECD TG 405, non-GLP, reliability 2)
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; [application time: 1, 5, 15 min and 20 h (OECD: 4 h); 2 animals used (OECD: 1-3); observation period 8 days (OECD: 14); skin changes recorded on working days; dose ~1 ml (OECD: 0.5 ml), additionally testing of the ear (not recomm. by the OECD guideline)
- Principles of method if other than guideline:
- Before OECD guideline 404 was established, skin irritation was tested using an internal method. White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5, 15 min and 20 h using occlusive conditions. An application site of 2.5 cm x 2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed for 8 days. Skin reaction was recorded after 1 h, 24 h, 48 h, 72 h, 96 h and after 7 and 8 days.
- GLP compliance:
- no
- Remarks:
- ; GLP was not compulsory at the time the study was conducted.
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male 3.32 kg, female 2.86 kg - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: the untreated sites of the same animal served as control.
- Amount / concentration applied:
- The test substance (ca. 2 g), moistured with water and mixed to a paste (concentration: 80 %), was applied to a 2.5 cm x 2.5 cm patch
- Duration of treatment / exposure:
- 1, 5, 15 min, 20 hours
- Observation period:
- The animals were observed following exposure for 8 days on working days. Skin changes were recorded after removal of the bandage after 1 hour as well as after 24 h, 48 h, and on day 6 and 8.
- Number of animals:
- 2 animals for each application times:
1 male and 1 female for the application time 20 h; 2 males for an application of 1, 5 and 15 minutes - Details on study design:
- The test substance, moistured with water and mixed to a paste, was applied to a 2.5 cm x 2.5 cm patch (~2 g) and placed on the clipped and intact skin of four white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions.
The right and the left flank of each animal was clipped and the test material was administered on both sites (on the left and on the right site each and each application was scored separately).
The test substance was removed on both sites by washing once. Skin reactions were recorded after 1 h, 24 h, 48 h, and on day 6 and 8. The application time used for assessment was 20 hours, the test material was applied on dorsal skin. The corresponding reading time points used for assessment were 24 and 48 hours after application. Dermal reactions were classified using a internal scoring system, which is convertible into the current OECD Draize scheme. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scale was seen on day 6
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scale was seen on day 6
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 72 hour time point was not evaluated
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 72 hour time point was not evaluated
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Under the experimental conditions chosen the mean scores for erythema after an application time of 20 hours under occlusive conditions indicate a mild irritating potential of the test substance.
- Executive summary:
A Draize test was performed with White Vienna rabbits. A 20-hour occlusive exposure to ca. 2 g of the test substance (moistured with water and mixed to a paste) produced mean scores for erythema of 2.5 for animal 1 (male) and 2.0 for animal 2 (female), regarding the readings after 24 h and 48 h. The mean scores for edema for all animals were 0. Scaling was seen in both animals on day 6. The effects observed were fully reversible at the end of the observation period on day 8.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; 50 mm3 (one sharp-edged spoon) of test material applied (OECD0.1 ml,< 100 mg); 4 animals were used (OECD: 3); the eyes were not washed out after 24 h (OECD: washing after 24 h); observation period was 8 days (OECD: 21)
- Principles of method if other than guideline:
- Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 µl or one sharp-edged spoon in case of solids of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day. - GLP compliance:
- no
- Remarks:
- ; GLP was not compulsory at the time the study was conducted.
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: animal 1: 3.11 kg; animal 2: 2.7 kg; animal 3: 3.34 kg; animal 4: 2.92 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye of the same rabbit was treated with 50 mg talcum powder.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: one sharp-edged spoon of the test substance, undiluted; ca. 50 mg - Duration of treatment / exposure:
- 24 h; the substance was not washed out.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Details on study design:
- One sharp-edged spoon (ca. 50 mg) of the undiluted, solid test substance was applied to the right conjuntival sac of one male and one female Vienna White rabbit. The left eye, treated withtalcum powder, served as a control. The substance was not washed out.
Ocular reactions were recorded after 10 min, 1, 3, 24, 48 and 72 hours, as well as 6 and 8 days after instillation in 2/4 animals or alternatively after 10 min, 1, 3, 24 and 48 hours, as well as 5, 6 and 9 days after instillation in the remaining two animals using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation the BASF scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours (animal 1 and 3) and 24, 48 hours after application (animal 2 and 4), respectively. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see table for details
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see table for details
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see table for details
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24-48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see table for details
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24-48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24-48 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see table for details
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: see table for details
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 24-48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item causes serious eye damage/irritation.
- Executive summary:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. The test substance was applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control.Talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
Severe eye irritation effects were seen in the treated eyes of the animals, including the occurence of staphyloma in two cases. The effects observed were in some cases not fully reversible at the end of the observation period after 8 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No reliable data for the test substance do exist. The toxicological assessment is based on the available data of CAS 10039-54-0 (skin irritation) and CAS 5470-11-1 (eye irritation).
Skin:
A Draize test (similar to OECD 404, non-GLP, reliability 2) was performed with White Vienna rabbits. A 20-hour occlusive exposure to ca. 2 g of the test substance (moistured with water and mixed to a paste) produced mean scores for erythema of 2.5 for animal 1 (male) and 2.0 for animal 2 (female), regarding the readings after 24 h and 48 h. The mean scores for edema for all animals were 0. Scaling was seen in both animals on day 6. The effects observed were fully reversible at the end of the observation period on day 8. Under the experimental conditions chosen the mean scores for erythema after an application time of 20 hours under occlusive conditions indicate a mild irritating potential of the test substance.
Eye:
Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. The test substance was applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control.Talcum powder was alternatively used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. Severe eye irritation effects were seen in the treated eyes of the animals, including the occurence of staphyloma in two cases. The effects observed were in some cases not fully reversible at the end of the observation period after 8 days.
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 1272/2008. In a reliable rabbit study the erythema scores for the test item treated tissues indicate the classification as mild skin irritant Cat.3.
The available data for eye irritation lead to a classification severe eye damage Cat. 1 (H318) under Regulation (EC) No. 1272/2008, as amended for the seventeenth time in Regulation (EC) No. 2021/849.
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