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EC number: 948-047-4 | CAS number: -
- 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
In a reliable in vivo skin irritation study New Zealand White rabbits (n=6) were exposed to a structurally similar substance by application of a 40% solution on clipped skin. The primary dermal irritation index was 0.29 and therefore the substance is not expected to be a skin irritant under the conditions of this study.
The potential for a structurally similar substance to cause irritation or corrosivity of a single dose into the eyes of New Zealand White rabbits (3/sex) was investigated in a reliable in vivo study. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during the study. Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation. The 24 hour Maximum Mean Total Score was 3 and based on this score the substance is considered to be minimally irritating to eyes.
In a reliable study a structurally similar substance was observed to be a mild eye irritant based on an in vivo eye irritation study New Zealand White rabbits, however the effects were not severe enough to warrant GHS classification.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of 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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Read-across to K2 study therefore K2 is the maximum Klimisch value.
- Justification for type of information:
- Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- The exposure period was for 24 hours as opposed to 4 hours as stated in the TG.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Olive oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml of a 40% solution.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Six
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: All animals
- Time point:
- 24/48 h
- Score:
- 0.29
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary dermal irritation index was 0.29 following dermal application of the subtance. Therefore, the substance is not expected to be a skin irritant under the conditions of this study.
- Executive summary:
In an in vivo skin irritation study New Zealand White rabbits (n=6) were exposed to the substance by application of a 40% solution on clipped skin. The substance was left on the skin for 24 hours. The treated skin was examined at 1 hour, 24- and 48 hours post-exposure. The substance produced slight erythma at 24 hours post-exposure. At 72 hours there was no erythma or oedema. The primary dermal irritation index was 0.29 and therefore the substance is not expected to be a skin irritant under the conditions of this study.
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:
- 5 June 1991 - 8 June 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- Following instillation the animals were returned to their respective cages for 24 hours. The eyes were not washed out following instillation.
- Observation period (in vivo):
- Ocular lesions were evluated 24, 48 and 72 hours post-administration.
- Number of animals or in vitro replicates:
- 3 Males and 3 females.
- Irritation parameter:
- maximum mean total score (MMTS)
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- other: Partially reversible within 72 hours
- Remarks on result:
- probability of mild irritation
- Other effects:
- All animals appeared active and healthy. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during th study.Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the scoring system used in this study the substance is considered to be minimally irritating to eyes.
- Executive summary:
The irritant or corrosive of a single dose of the substance into the eyes of New Zealand White rabbits (3/sex) was investigated in this in vivo study. One eye of each rabbit was instilled with 0.1g of the test substance and irritation was scored at 24, 48 and 72 hours administration. All animals appeared active and healthy. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during th study.Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation. The 24 hour Maximum Mean Total Score was 3 and based on this score the substance is considered to be minimally irritating to eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Justification for type of information: Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- other: Olive oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of a 40% solution.
- Duration of treatment / exposure:
- 18 hours
- Observation period (in vivo):
- 7 days.
- Number of animals or in vitro replicates:
- Six
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: All animals
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: All animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - 8.33
- Max. score:
- 8.33
- Reversibility:
- fully reversible
- Remarks on result:
- probability of mild irritation
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- The substance is expected to be a mild eye irritant based on an in vivo eye irritation study New Zealand White rabbits.
- Executive summary:
In an in vivo eye irritation study New Zealand White rabbits were exposed to the substance by instillation of the substance into one eye. The corresponding eye of the same animal was left untreated and acted as concurrent control. The treated eyes was washed out and the eyes were examined at 1 hour, 2, 4 and 7 days post exposure. The substance produced slight to mild conjunctival irritation at 24 hours post-administration. At 7 days, no signs of irritation was observed in all animals dosed. The substance is expected to be a mild eye irritant under the conditions of this study.
Referenceopen allclose all
Incidence of Irritation
Corneal Opacity | Iritis | Conjunctival Irritation | |
24 hours | 0/6 | 0/6 | 6/6 |
48 hours | 0/6 | 0/6 | 4/6 |
72 hours | 0/6 | 0/6 | 2/6 |
Severity of Irritation
Maximum Mean Irritation Score | |
24 hours | 3 (minimally irritating) |
48 hours | 1.3 (practically non-irritating) |
72 hours | 0.7 (practically non-irritating) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the findings of a reliable in vivo skin irritation study conducted on a structurally similar substance and a reliable in vivo eye irritation study conducted on the substance, classification of the substance is not justified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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