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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 603-894-6 | CAS number: 135108-88-2
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similar to guideline study, non-GLP, but using a high-lipid diluent to maximize percutaneous absorption.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- high-lipid diluent to maximize percutaneous absorption
- Principles of method if other than guideline:
- similar to a Buehler protocol
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Historical study
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
- Route:
- other: dermal application to abraded skin
- Vehicle:
- other: acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
- Concentration / amount:
- Induction: no data. Challenge: 2% in acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
- Route:
- other: dermal application to intact and abraded skin
- Vehicle:
- other: acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
- Concentration / amount:
- Induction: no data. Challenge: 2% in acetone/dioxane (1:1 v/v) with 13% guinea pig fat.
- No. of animals per dose:
- 5 guinea pigs challenged with intact skin, 5 guinea pigs challenged with abraded skin
- Details on study design:
- The test material, as a solution in acetone/dioxane (1:1 v/v) with 13% guinea pig fat, was applied to the abraded skin of 10 guinea pigs 9 times over 3 weeks. After a 2 week rest period, the material was reapplied at a level of 2% in the same diluent to intact and abraded skin, as a challenge dose. Sensitization of the animals was then assessed qualitatively.
- Challenge controls:
- no data
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2% on challenge
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- assume reading was 24 h after challenge.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2% on challenge. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: assume reading was 24 h after challenge..
- Conclusions:
- 4,4'-Methylenedicyclohexanamine was a weak sensitiser on abraded skin of guinea pigs in a diluent of acetone/dioxane with 13% fat content, .
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
One of the components of this UVCB material is a skin sensitizer therefore it is reasonable to assume that this material may be able to cause sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Similar materials are not respiratory sensitzers.
Justification for classification or non-classification
Based on the data of similar materials and according to CLP Regulation (1272/2008), the test substance is classified as a skin sensitizer (Cat 1C).
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.