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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 228-995-9 | CAS number: 6388-26-7
- 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
Non irritant to rabbit skin and 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
- Study period:
- From March 28 to April 6, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h: 3 rabbits
1 h or 3 min: 1 rabbit - Observation period:
- 72 h
- Number of animals:
- 4 h: 3 rabbits
1 h or 3 min: 1 rabbit - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- 'Dermal toxicity' in Appraisal of the safety of chemicals in foods, drugs and cosmetics, Assoc. of food and drug offcials of the US, Draize (1959) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- Dark green coloured staining is observed.
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non irritant to the rabbit skin.
- Executive summary:
Method
Skin irritation in rabbits according to OECD guideline 404. A single 4 -hour, semi occluded application (0.5 g) of test substance was administered to the intact skin of 3 rabbits; 3 -minute and 1 -hour semioccluded applications (0.5 g) of test substance were administered to the intact skin of one rabbit. Observations for erythema and oedema were done 24, 48 and 72 hours after start of exposure.
Results
No signs of erythema and oedema were noted. Dark-green coloured staining was noted.
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:
- From April 10 to 19, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Amount / concentration applied:
- 0.1 ml (69.3 mg)
- Observation period (in vivo):
- 72 h
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- washing: no - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Other effects:
- Black staining of the nictitating membrane and of the fur around the treated eye was noted.
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to the rabbit eye.
- Executive summary:
Method
Eye irritation in rabbits according to OECD guideline 405.Test substance was applied to the non irrigated eye of 3 rabbits as single application of 0.1 ml (69.3 mg). Observations for signs of irritation on cornea, iris and conjunctivae were done 1, 24, 48 and 72 hours after instillation.
Results
Conjunctival redness was noted in all treated eyes at the 24 -hour observation. However, all treated eyes appeared normal at the 48 -hour observation. Black staining of the nictitating membrane and of the fur around the treated eye was also noted.
Reference
effect | 24 h | 48 h | 72 h | ||||||
rabbit no. | |||||||||
1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
cornea opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
conjunctivae redness | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
conjunctivae chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin and eye irritation potential of the substance was evaluated based on in vivo studies.
Skin irritation
In the key study, the substance was tested for skin irritation according to OECD 404. Under test conditions, no signs of skin irritation were noted. In the area of application dark-green staining of the skin was observed in all rabbits. No acute toxicological signs were seen in animals during the test period.
Such findings were confirmed by an older study: at the 24 -hour observation time, signs of erythema and oedema were evident, which disappeared within the 72 -hour observation time.
Eye irritation
In the key study, the substance was tested for eye irritation/corrosion according to OECD 405. Conjuctivae redness was noted in all rabbits at the 24 -hour observation; however, all treated eyes appeared normal at the 48 -hour observation. Staining of the nictitating membrane was also noted.
Similar finding were obtained in an older study: conjunctival redness was noted in rinsed and unrinsed eyes, being more evident in unrinsed eyes. In any case, irritation signs completely disappeared within 10 days.
Justification for classification or non-classification
Skin Irritation
According to the CLP Regulation (EC 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
A substance has to be classified as category 1 (corrosive) if it 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 a 4 hour duration.
A substance has to be classified as category 2 (irritant) if shows:
- mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings 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.
Under the test condition, no signs of irritation were observed, thus no classification applied.
Eye Irritation
According to the CLP Regulation (EC 1272/2008), 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.
A substance has to be classified as category 1 (Irreversible effects on the eye), 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.
A substance has to be classified as category 2 (irritating to eye) if, 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.
Under test conditions, irritation signs were well below the threshold of classification and disappeared within the end of the observation period. Therefore, no classification applied.
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.