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EC number: 276-675-2 | CAS number: 72479-28-8
- 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
Non skin irritating
Non irritating to eye
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of Chemicals in Food, Drugs and Cosmetics (1959) of the US association AFDO
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Age at study initiation: adult animals- Weight at study initiation: 1.3- 2.7 kg- Housing: single housing in V2A wire cages- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact and scarified skin
- Vehicle:
- not specified
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 males + 3 females)
- Details on study design:
- TEST SITE- Area of exposure: 2.5 cm x 2.5 cm on back and flank- Type of wrap: plastic films of 5 x 5 cm fixed to the body with adhesive tape
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritant response data after a 24-hours occlusive exposure to intact skin. The primary irritaion index is 0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not irritating to the rabbit skin.
- Executive summary:
The test item was tested for skin irritation and the test results showed a primary irritation index of 0 in all the trated animals.
The tested substance could be considered as a not skin irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics (1959) of the association (AFDO).
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Russian Breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Exp. Toxicology, CIBA-Geigy Ltd.- Housing: single housing in V2A wire cages - Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.1 g
- Duration of treatment / exposure:
- few seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (3 males + 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.SCORING SYSTEM: according to DraizeTOOL USED TO ASSESS SCORE: hand-slit lamp
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed and rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.665
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed and rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: unrinsed
- Irritant / corrosive response data:
- The tested substance showed some irritating effect of conjunctivae (redness) during the first 24 hours but the irritation signs were fully reversible within 96 hours for the unrinsed eyes. No effects on iris and on cornea and for chemosis.
- Interpretation of results:
- other: not irritating
- Conclusions:
- Under the conditions of this experiment the test material was found to cause a minimal irritation during the first 24 hours, the irritation effects were fully reversible. The test material is considered to be not irritating to the eye.
- Executive summary:
Based on the test results, the test material is considered to be not irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Respiratory irritation
Tests on this pourpose have not been conducted; nevertheless the tested substance is not expected to be a respitatory irritant.
Justification for classification or non-classification
Based on indication on the Regulation CE 1272/2008:
SKIN IRRITATION/CORROSION
A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to 4 hour duration.
Three subcategories are provided within thecorrosive category 1:
Subcategory 1Awhere responses are noted following up to 3 minutes exposure and up to 1 hour observation;
Subcategory 1Bwhere responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days;
Subcategory 1C where responses occur after exposures between 1 hour and 4 hours and observations up to 14 days
To classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.
Category 2:
- Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from grading at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
- Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
- In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
The substance is not classified as skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
EYE IRRITATION
Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.
Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
Irreversible effects on the eye (Category 1):
If, when applied to the eye of an animal, a substance produces:
- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
- at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 3 and/or iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Substances are also classified in Category 1 if they fulfil the criteria of corneal opacity ≥ 3 or iritis > 1,5 detected in a Draize eye test with rabbits, recognising that such severe lesions usually do not reverse within a 21-day observation period.
The substance does not meet the requirements to be classified in Category 1.
Irritating to eyes (Category 2)
when applied to the eye of an animal, a substance produces:
- at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
The substance does not meet the requirements to be classified in Category 2.
Based on the available tests, the substance should be considered as not eye irritant.
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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