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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 270-485-3 | CAS number: 68442-68-2
- 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: In vivo skin irritation study, New Zealand White rabbit, m/f, 500 µl/animal, 24h exposure, undiluted substance: not irritating
Skin irritation: In vivo skin irritation study, New Zealand White rabbit, m/f, 500 µl/animal, 24h exposure, 50% solution: not irritating
Eye irritation: In vivo eye irritation study, New Zealand White rabbit, m/f, 100 µl/eye, no wash-out, undiluted substance: not irritating
Eye irritation: In vivo eye irritation study, New Zealand White rabbit, m/f, 100 µl/eye, no wash-out, 50% solution: not irritating
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: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed.
- Principles of method if other than guideline:
- Test item was applied for 24h to the inner side of the ear of two rabbits, post-observation period was 7 days after washing.
- GLP compliance:
- no
- Remarks:
- study performed prior to GLP implementation
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male/female
- Weight at study initiation: 3-4 kg
- Housing: individually - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl/animal - Duration of treatment / exposure:
- 24h
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: inner side of the ear
- Type of wrap if used: adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and soap / vegetal oil
- Time after start of exposure: 24h - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: mean Day 0 and 2 postobservation
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was conducted with a scientifically reasonable study design on the registered substance itself with some deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits. The results indicate that the substance is not irritating to rabbit skin and no classification as skin irritant according to Regulation 1272/2008 is triggered.
- Executive summary:
In a primary dermal irritation study, two New Zealand White rabbits (m/f) were dermally exposed to 500µl of the undiluted test item for 24h hours to the inner side of the ear. Animals then were observed for 7 days.
Maximum score was observed at day 2 post observation (1). In this study, the test item is not a dermal irritant, no classification is needed.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed.
- Principles of method if other than guideline:
- Test item was applied to the conjunctival sac of two rabbits, post-observation period was 7 days.
- GLP compliance:
- no
- Remarks:
- study performed prior to GLP implementation
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male/female
- Weight at study initiation: 3-4 kg
- Housing: individually - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100µl - Duration of treatment / exposure:
- 7 days (no wash-out after application denoted)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: mean 1, 2, 3, 7 days
- Score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: not irritating
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was conducted with a scientifically reasonable study design on the registered substance itself with some deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits. The results indicate that the substance is not irritating to the rabbit eye and no classification as eye irritant according to Regulation 1272/2008 is triggered.
- Executive summary:
In a primary eye irritation study, 100µl of the undiluted test item was instilled into the conjunctival sac of the eye of two New Zealand White rabbits (m/f). Animals then were observed for 7 days.
In this study, the test item is not an eye irritant and does not need to be classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
There are each two studies available assessed with Klimisch 2 for skin and eye irritation, either with 100% of the registered substance or as test material containing 50% of the registered substance. The studies were not performed according to the latest OECD guidelines, but the studies were conducted with a scientifically reasonable study design on the registered substance itself (or 50% solution) with some deficiencies in documentation, and the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits, either skin or eye. Also, in vivo methods can be considered to mimick human exposure more precisely than the current in vitro methods, leaving no doubt that the results are not relevant for human risk assessment. The tonnage-driven data requirements under REACH are fully met as all studies are in vivo results. All studies consistently reveal that there is no need to classify the test item as irritating to skin or eye. The database is hence of good quality, no data gaps were identified, and the substance can hence be considered as neither irritating tot he skin or eye during human risk assessment
Justification for selection of skin irritation / corrosion
endpoint:
More detailed study report available, test performed on 100% of the
registered substance instead of 50%.
Justification for selection of eye irritation endpoint:
More detailed study report available, test performed on 100% of the
registered substance instead of 50%.
Justification for classification or non-classification
The available data (all studies assessed with Klimisch 2) consistently revealed that the substance does not induce even undiluted any relevant signs of irritiation, neither for skin nor eye, and does hence not trigger the need for classification as skin or 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.
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.