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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-109-7 | 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
not skin irritant for rabbits
eye irritant for rabbits
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- An area of at least 6 cm2 was shaved on both flanks of the animals approx. 24 hours before treatmnet.
0.5 g of the test compound was applied to each test site on a 3 cm square surgical gauze pad (20 cm2).
This were covered with aluminium foil (36 mm2) and then covered with an occlusive dressing for 4 hours.
The dressing was wrapped with an adhesive tape (isoplast AG, CH). - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours and for other 7 days
- Number of animals:
- 3 male rabbits
- Details on study design:
- Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved.
- Irritation parameter:
- erythema score
- Basis:
- other: mean of all animals
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- other: mean of all animals
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- No irritation effect observed on all animals.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. - Other effects:
- Coloration: in the area of application a clear visible red stained of the test skin was observed in animals 76 and 77 up to 48 hours and in animal 75 up to 72 hours which could be related to effects of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred. - Interpretation of results:
- not irritating
- Remarks:
- OECD GHS
- Conclusions:
- Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.
- Executive summary:
The primary irritation score was assessed following OECD 404.
The results show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under Regulation EC 1272/2008 .
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye serves as control
- Amount / concentration applied:
- 0.1 g of the test substance
- Duration of treatment / exposure:
- eye lids close for 1 seconds
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- 3 males
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 24-72 hours all animals
- Time point:
- other: 24-72 hours
- Score:
- 1.33
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-72 hours
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-72 hours
- Score:
- 1.33
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- The tested substance ahowed a primary irritation score of:
1.33 for cornea
1 for iris
2 for conjunctivae redness
1.33 for conjunctivae chemosis
when applied to the rabbit eye mucosa.
The effect was not reversible in 21 days except for chemosis which is fully reversible within 14 days. - Interpretation of results:
- irritating
- Remarks:
- OECD GHS
- Conclusions:
- The tested substance needs to be considered irritant for rabbits eyes under Regulation CE 1272/2008.
- Executive summary:
The ocular reactions were determined followign OECD 405.
The tested substance is considered to be irritant for the rabbits eyes based on the results needs to be classified as H319, Causes serious eye irritation under Regulation 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the results the tested substance could ne considered not irritant for the skin and irritant for eyes.
Justification for selection of
skin irritation / corrosion endpoint:
The study was performed on official guidelines
Justification for selection of eye irritation endpoint:
The study was performed on official guidelines
Effects on eye irritation: irritating
Justification for classification or non-classification
No classification for skin irritation/corrosion is warranted under Regulation EC n. 1272/2008
Classification for eye irritation/corrosion is warranted under Regulation EC n. 1272/2008: H319, Causes serious eye irritation
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.