Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 223-362-3 | CAS number: 3855-32-1
- 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
The substance is Category 1 corrosive on the basis of destruction of skin tissue (visible necrosis through the epidermis and into the dermis) , as cobserved in a study on rabbits.
Three subcategories are provided within the corrosive category: Subcategory 1A – where responses are noted following up to 3 minutes exposure and up to 1
hour observation; subcategory 1B – where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days; and subcategory 1C – where
responses occur after exposures between 1 hour and 4 hours and observations up to 14 days.
The test provided did not note reaction times of under 4 hours, the severe and irrevesible skin damage produced in all tested animals indicate that the substance is likely to be severely corrosive to the skin.
(ECHA Guidance on the Application of the CLP Criteria Nov 2013)
Furthermore, read-across from structurally similar substances shows good correlation wth regard to the corrosive effects.
The corrosive potential of the substance is also confirmed in repeat-oral dose animal toxicity studies, where noticeable and severe lesions of the forestomach and GI tract, along with clinical signs of distressed animals, are supportive of the corrosive classification.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study preceeds current OECD guidelines, however is equivalent to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). No GLP, however the study is sufficiently reported and the results unambiguous.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- open
- Preparation of test site:
- other: Intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5ml per application
- Duration of treatment / exposure:
- 4-72 hours
- Number of animals:
- 3 dose groups of 6 aminals each for intact skin
3 dose groups of 6 aminals each for abraded skin
32 animal in total
No controls - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: after 4hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to skin of Rabbits.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: after 4 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severly damaging to skin of rabbits
- Irritation parameter:
- edema score
- Basis:
- mean
- Score:
- >= 0 - < 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to skin of rabbits
- Irritant / corrosive response data:
- Severely damaging to skin of rabbits. No recovery noted in any animal after 30-day recovery period.
- Other effects:
- For intact and abraded skin, at all does levels there was vocalisation and ataxia, with abraded skin animals showing more makred effects.
Increasing doses showed signs of decresed activity, prostration, lethargy ataxia, dyspnea and death. - Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The subsatnce is corrosive to the skin of rabbits, with no recovery afte a 30-day recovery period. The substance should be considerd corrosive to the skin and eyes, nasal and respiratory tracts.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study preceeds current OECD guidelines, however is equivalent to OECD Guideline 405 (Acute Eye Irritation / Corrosion). No GLP, however the study is sufficiently reported and the results unambiguous.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- 5 minutes exposure with 48-hour observation period
24-hours exposure with 72-hour observation period - Number of animals or in vitro replicates:
- 2 groups, 8 per group
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 5 minute sexposure
- Score:
- >= 1 - < 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to eyes of rabbits.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-hour exposure
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to eyes of rabbits.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 5 minute exposure
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to eyes of rabbits.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hour exposure
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to eyes of rabbits.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 5 minute exposure
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to eyes of rabbits.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hour exposure
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Severely damaging to eyes of rabbits.
- Irritant / corrosive response data:
- The substance is severely damaging to eyes of rabbits, with no recovery after 30-day observation period.
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is severely damaging to eyes of rabbits, with no recovery after 30-day observation period. The substance is severely irritating and corrosive to the skin and eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for selection of skin irritation / corrosion endpoint:
In a skin irritation study in Rabbits using intact and abraded skin,
the substance was found to be severely damaging, with no recovery noted
in any animal after 30-day recovery period.
The substance is corrosive.
Justification for selection of eye irritation endpoint:
In an ocular irritation study in rabbits, the substance was severely
damaging to the eyes, with no recovery after 30-day observation period.
The substance is severely irritating and corrosive to the skin and eyes.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Effects on respiratory irritation: highly irritating
Justification for classification or non-classification
In a skin irritation study in Rabbits using intact and abraided skin, the substance was found to be severely damaging, with no recovery noted in any animal after 30-day recovery period. In an ocular irritation study in rabbits, the substance was severely damaging to the eyes, with no recovery after 30-day observation period. The substance has been demonstrated to be corrosive to the skin and eyes of rabbits. Corrosion damage was not reversible after 30 days.
Based on the result of in vivoskin irritation study, the substance needs to be classified as C, R34 according to the DSD and as Category 1B, H314 under the CLP classification criteria.The substance needs to be classified with Xi, R41 and Eye Damage 1, H318 according to classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008, respectively
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.