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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 430-970-4 | 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 the available skin and eye irritation/ corrosion studies in rabbits performed according to OECD Guidelines 404 and 405 respectively, the test substance showed no irritation/ corrosion effects.
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:
- 1999-02-16 until 1999-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- EPA 712-C-96-196, June 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg, Germany
- Weight at study initiation: 2.6 - 2.7 kg
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogen free-TPF
- Water: tap water
- Acclimatisation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: artificial light, lighting regime 12 : 12 hours, light 6.30 -18.30 - Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- other: CMC (drop down)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Single dose of 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (14 days observation period was not required as no indications which had to be examined for reversibility were observed).
- Number of animals:
- 3 female animals
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on one side of the dorsal area
- Type of wrap if used: the test item was applied to the patch first (gauze patch), and then applied to the skin. The patch was fixed with a semi-occlusive dressing with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: as indicated in the OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean score animal 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean score animal 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period.
- Other effects:
- No other effects
- Interpretation of results:
- not classified
- Conclusions:
- Under the conditions of this study, the test substance was considered to have no skin irritation/corrosive effects.
- Executive summary:
The test substance was tested for its skin irritation/ corrosion properties in a study performed according to EU Method B.4, OECD Guideline 404 and EPA OPPTS 870.2500. The test substance was applied to one site of the clipped back of 3 rabbits at a dose of 0.5 g per application site while the untreated side served as control. The application site was covered with a semi-occlusive bandage for a 4 hour - contact/ exposure time. Observations were recorded and compared to the control sites, 1, 24, 48 and 72 hours after removal of the patch. The test item showed no irritant/ corrosive effects on the intact skin within 72 hours after removal of the test item. No other clinical signs of toxicity were observed. Under the conditions of the study, the test substance was considered to have no irritation/corrosive properties.
- 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
There were no significant body weight changes during the contact and observation period.
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:
- 1999-02-22 until 1999-02-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 Feb., 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- EPA 712-C-96-195, June 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg, Germany
- Weight at study initiation: 2.6 - 2.9 kg
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet rabbit, rich in crude fibre, totally pathogen free-TPF
- Water: tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 55+ 10%
- Air changes: :at least 10 x / hour
- Photoperiod: artificial light, lighting regime 12 : 12 hours, light 6.30 -18.30 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g of the test substance
- Duration of treatment / exposure:
- 72 hours (same as the observation period as the test substance was not washed away)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 female animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed
SCORING SYSTEM: as indicated in the OECD Guideline 405
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean score animal 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean score animal 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- mean score animal 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- mean score animal 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The application of the test item at a dose of 0.1 g caused minimal blepharospasm in all animals immediately after the application.
1 hour after application a slight erythema of the conjunctivae was visible two of three animals.
No signs of irritation were visible at the 24 h reading in all of the 3 test animals.
No Cornea lesions were found upon fluorescein examination at the 72 h reading.
The test item produced no corrosion or irreversible effects in any of the animals.
No other toxic effects were observed. - Interpretation of results:
- not classified
- Conclusions:
- Under the study conditions it was concluded that the test item caused no irritation and no corrosive effects to the eyes of rabbits.
- Executive summary:
The test item was tested for its eye irritation/ corrosion properties according to EU Method B.5, OECD Guideline 405 and EPA OPPTS 870.2400. In the available study the test item was applied to the lower conjunctival sac of one eye of 3 rabbits at a dose of 0.1 g per application site and it was not rinsed thereafter. The untreated eye served as control. Observations were calculated and compared to controls 1, 24, 48 and 72 hours after application of the test item. Application of the test item caused minimal blepharospasm in all animals immediately after application and 1 hour after application a slight erythema of the conjunctivae was visible. No signs of irritation were visible at the 24 hours reading in all of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. Thus, the mean cornea, iris, conjunctivae score redness and chemosis for all 3 animals was 0. No corrosion effect were observed. Under the study conditions the test item was considered to have no irritation and no corrosive effects to eyes of rabbits.
- 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:
- no adverse effect observed (not irritating)
Additional information
Skin:
The test substance was tested for its irritation/ corrosion properties in a study performed according to EU Method B.4, OECD Guideline 404 and EPA OPPTS 870.2500. The test substance was applied to one site of the clipped back of 3 rabbits at a dose of 0.5 g per application site while the untreated side served as control. The application site was covered with a semi-occlusive bandage for a 4 hour - contact/ exposure time. Observations were recorded and compared to the control sites, 1, 24, 48 and 72 hours after removal of the patch. The test item showed no irritant/ corrosive effects on the intact skin within 72 hours after removal of the test item. No other clinical signs of toxicity were observed. Under the conditions of the study, the test substance was considered to have no irritation/corrosive properties.
Eye:
The test item was tested for its eye irritation/ corrosion properties according to EU Method B.5, OECD Guideline 405 and EPA OPPTS 870.2400. In the available study the test item was applied to the lower conjunctival sac of one eye of 3 rabbits at a dose of 0.1 g per application site and it was not rinsed thereafter. The untreated eye served as control. Observations were calculated and compared to controls 1, 24, 48 and 72 hours after application of the test item. Application of the test item caused minimal blepharospasm in all animals immediately after application and 1 hour after application a slight erythema of the conjunctivae was visible. No signs of irritation were visible at the 24 hours reading in all of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. Thus, the mean cornea, iris, conjunctivae score redness and chemosis for all 3 animals was 0. No corrosion effect were observed. Under the study conditions the test item was considered to have no irritation and no corrosive effects to eyes of rabbits.
Justification for classification or non-classification
Based on the results obtained, the test substance was not classified and labelled for skin and eye irritation/ corrosion according to Regulation No (EC) 1272/2008 (CLP).
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.