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EC number: 440-740-5 | 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
Skin irritation
Key, rabbit, semiocclusive, OECD 404, GLP: negative
Eye irritation
Key, rabbit, OECD 405, GLP: negative
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:
- 09 MAR 2000 - 19 JUN 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 1992
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 25 weeks
- Weight at study initiation: mean 4.14 kg (range from 3.32 to 4.86 kg)
- Housing: All rabbits were housed in an air-conditioned room of about 28 m² in the Institute of Toxicology. They were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm) with plastic grids placed on mobile racks. The collection pans underneath the cages were cleaned at least three times a week. The cages were cleaned before the start of the study.
- Diet (e.g. ad libitum): ad libitum, the diet is checked periodically according to the specifications of the manufacturer by an independent laboratory, approved by the German government. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
- Water (e.g. ad libitum): ad libitum, the drinking water is periodically analyzed according to the German regulations for human drinking water.
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 46 - 65
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): in some drops of Aqua pro injectione
VEHICLE
- Amount(s) applied (volume or weight with unit): some drops of Aqua pro injectione
- Lot/batch no. (if required): 0189 - Duration of treatment / exposure:
- 4 h
- Observation period:
- The rabbits were examined for skin alterations, behavior, and general condition 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to day 8 of the study.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: patch, the patches were fastened to the left side of the animals backs and kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any test material residues were wiped off
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to day 8 of the study
SCORING SYSTEM:
- Method of calculation: Skin changes at the application sites were evaluated according to the DRAIZE-, OECD- and EEC recommendations. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed in the treated areas.
- Other effects:
- Symptoms
No signs of clinical toxicity were detected.
Mortality
All animals survived the observation period.
Body weight
Body weight development of the treated rabbits was inconspicuous. - Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The test substance was shown to cause no skin irritation when applied under semiocclusive conditions.
- Executive summary:
The skin irritation potential of the registered substance was tested in rabbits according to OECD Guideline 404 and GLP. The test item was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for further 7 days. The test substance was shown to cause no skin irritation.
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:
- 15 MAR 2000 - 19 JUN 2000
- 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:
- 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 25 weeks
- Weight at study initiation: 4.25 kg (range 3.98 - 4.73 kg)
- Housing: All rabbits were housed in an air-conditioned room of about 28 m² in the Institute of Toxicology. They were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm) with plastic grids placed on mobile racks. The collection pans underneath the cages were cleaned at least three times a week. The cages were cleaned before the start of the experimental part.
- Diet (e.g. ad libitum): ad libitum, the diet is checked periodically according to the specifications of the manufacturer by an independent laboratory, approved by the German government. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
- Water (e.g. ad libitum): ad libitum, the drinking water is periodically analyzed according to the German regulations for human drinking water.
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 46 - 65
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- After instillation, the eyelids were closed for about 30 seconds. The test item was not removed.
- Observation period (in vivo):
- 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no
SCORING SYSTEM: Eye changes were evaluated according to the DRAIZE- , OECD- and EEC- recommendations.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (score 1), Chemosis (score 1), and discharge (score 2) from day 1 up to day 5 of the study. Redness of conjunctivae on days 4 and 5 of the study concerned the nictating membrane. Later on no signs of irritation were observed. The untreated eyes were unchanged.
- Other effects:
- - Other observations: Body weight development of the treated rabbits was inconspicuous. All animals survived the observation period. No signs of clinical toxicity were detected.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (score 1), chemosis (score 1), and discharge (score 2) from day 1 up to day 5 of the study. Later on no signs of irritation were observed. The untreated eyes were unchanged.
- Executive summary:
The test item was tested for eye irritation according to OECD Guideline 405 and GLP. 0.1 g of the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for further 7 days. No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (score 1), chemosis (score 1), and discharge (score 2) from day 1 up to day 5 of the study. Later on no signs of irritation were observed. The untreated eyes were unchanged.
Reference
for details on results, please refer to tables under 'Attached background material'
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritation potential of the registered substance was tested in rabbits according to OECD Guideline 404 and GLP. The test item was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for further 7 days. The test substance was shown to cause no skin irritation.
Eye irritation
The registered substance was tested for eye irritation according to OECD Guideline 405 and GLP. 0.1 g of the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for further 7 days. No signs of irritation were observed at the cornea and iris. The conjunctivae showed redness (score 1), chemosis (score 1), and discharge (score 2) from day 1 up to day 5 of the study. Later on no signs of irritation were observed. The untreated eyes were unchanged.
Justification for classification or non-classification
Based on the available results no classification for irritation is triggered in accordance with Regulation (EC) No 1272/2008.
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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