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EC number: 235-527-7 | CAS number: 12262-58-7
- 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
Based on the available studies the substance is severely irritating to rabbit skin and corrosive to the 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Adequate details however 24 hour exposure; no COA; non-GLP. Needs test article id statement
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: USA Federal Hazardous Substances Act (US-FHSA),
- Deviations:
- not specified
- Principles of method if other than guideline:
- USA Federal Hazardous Substances Act (US-FHSA),
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- None provided.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours after application
- Number of animals:
- Six rabbits are treated on intact ski and six on abraded skin
- Details on study design:
- Twelve healthy adult New Zealand White albino rabbits are used for 1-4 test substances. Twenty four hours prior to applying the materials, hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An amount of 0.5 ml of the test substance is brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abrades. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or the product bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize (J. Pharmacol. 82 (1944) 377-390). A second reading is made 48 hours later (72 hours after application).
In the case of surface active test substances the skin reactions after 72 hours usually consist of scaliness and/or necrosis,. Since the Draize grading system does not comprise these abnormalities the second reading is carried out on the basis of the laboratory's own grading system. - Irritation parameter:
- overall irritation score
- Remarks:
- Erythema plus edema
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 6.7
- Max. score:
- 8
- Reversibility:
- other: No data reported
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- other: No data reported
- Remarks on result:
- other: intact skin
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema and edema
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 6.8
- Max. score:
- 8
- Reversibility:
- other: No data reported
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- overall irritation score
- Remarks:
- erythema
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- other: No data reported
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- After 24 hours: distinct ischemia and slight or moderate edema.
After 72 hours: very slight to distinct scaliness or incrustation. - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test substance is a severe to very severe primary skin irritant.
- Executive summary:
The test article was evaluated for its potential skin irritation potential. The test article was applied to the intact and abraded skin of rabbits for 24 hours and the reactions scored according to the Draize method 24 and 72 hours following application.
The test article was severely irritating to rabbit skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
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: Adequate details; no COA; non-GLP. Needs test article id statement
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FDA - Draize Test
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- None provided.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- One tenth of a milliliter
- Observation period (in vivo):
- The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- one
- Details on study design:
- The eyes of the animals are examined before testing and only those animals without observable eye defects are used. On tenth of a milliliter of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent loss of material. The other eye remaining untreated serves as a control. The eyes are not washed following installation and the animals are released immediately.
The eyes are examined at 24, 48, 72 and 7 days after instillation of the test material.
An animal is considered as giving a positive reaction if there is, at any of the readings, discernible opacity of the cornea (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection), or if such substances produce in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA scoring scale was used.
Ocular reactions are read using a binocular magnifying glass. The diagnosis of corneal damage is confirmed if necessary by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes are examined in a dark room under ultraviolet illumination.
A substance which has elicited corneal and/or iris lesions which have not cleared by the seventh day reading, is considered a severe eye irritant. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: only one animal used
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: only one animal used
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: only one used
- Time point:
- 24 h
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Remarks on result:
- other: conjunctivae were necrotic
- Irritation parameter:
- chemosis score
- Basis:
- animal: only one used
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: only one used
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: only one used
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: only one used
- Time point:
- 48 h
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Remarks on result:
- other: conjunctivae were necrotic
- Irritation parameter:
- chemosis score
- Basis:
- animal: only one used
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: only one used
- Time point:
- 72 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: only one used
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: i
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: onnly one used
- Time point:
- 72 h
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Remarks on result:
- other: conjunctivae were necrotic
- Irritation parameter:
- chemosis score
- Basis:
- animal: only one used
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: only one used
- Time point:
- 7 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: only one used
- Time point:
- 7 d
- Remarks on result:
- other: iris not discernable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: only one used
- Time point:
- 7 d
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- after 7 days
- Remarks on result:
- other: conjunctivae were necrotic
- Irritation parameter:
- chemosis score
- Basis:
- animal: only one used
- Time point:
- 7 d
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- after 7days
- Irritant / corrosive response data:
- Moderate to complete corneal opacity, slight iritis,
necrosis of the conjunctivae and swelling with lids
about half closed.
The ocular lesions suggested permanent blindness. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test article caused very severe irreversible eye damage.
- Executive summary:
The test article was evaluated for potential eye irritation. One tenth of a milliliter was instilled into one eye of one rabbit. Reactions were evaluated at 24,48, 72 hours and 7 days following instillation.
The test article induced very severe irreversible eye damage.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available studies the substance is severely irritating to rabbit skin and corrosive to the eye. The harmonized classification for the substance is corrosive to skin and eye, category 1b and 1, 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.
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