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EC number: 217-168-8 | CAS number: 1761-71-3
- 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
All available animal studies suggest that 4,4'-methylenedicyclohexanamine is a weak dermal sensitiser (DuPont 1985, BASF 1956, Kennedy 1991). In vivo studies are technically complicated due to the corrosive nature of the substance which is classified as skin corrosive substance Cat. 1B. It is commonly known that substances showing a low to moderate frequency of sensitisation effects in humans or low to moderate potency in animals can be presumed to produce sensitisation in humans and are classified in Category 1B.
4,4'-Methylenedicyclohexanamine falls into this category.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Historical study
- 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 available
- 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.
- Day(s)/duration:
- 9 times over 3 weeks
- 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.
- Day(s)/duration:
- once to intact and abraded skin
- 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
- 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 an exaggerated protocol using a diluent of acetone/dioxane with 13% fat content, .
- Executive summary:
The test material, as a solution in f.a.d. was applied to the abraded skin of 10 guinea pigs 9 times over a 3-week period. Following a two-week rest period, the material was reapplied as a 2 % solution in f.a.d. twice to intact and abraded skin for the challenge test. Seven of the ten guinea pigs became sensitized when treated in this manner. One of these animals showed a consistently positive reaction, while the other six animals showed transitory positive reactions. On the basis of these results, the test material can be classified as a weak skin sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The evidence in the literature regarding the skin sensitisation caused by this substance is not particularly robust. The SIDS initial assessment profile for C1 -C13 primary amines group (which includes 4,4'-methylenebis(cyclohexylamine)) is reporting no evidence of sensitization for the group members. DMDC a close structural analogue to PACM is not a skin sensitizer. PACM appears to be a weak sensitiser in guinea pigs so the precautionary approach is adopted and the material is considered a sensitiser. Personal protective equipment (gloves, eye protection) is recommended for use with this substance due to its corrosive properties and should protect for potential sensitisation.
Migrated from Short description of key information:
4-4’-Methylenedicyclohexanamine is a weak sensitiser in guinea pigs.
Justification for selection of skin sensitisation endpoint:
Weight of evidence suggests that the substance has weak sensitising properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
In the absence of relevant data, PACM is not classified as a respiratory sensitiser.
Justification for classification or non-classification
Animal studies suggest that 4,4'-methylenedicyclohexanamine is a weak dermal sensitiser. In vivo studies are technically complicated due to the corrosive nature of the substance. Substances showing a low to moderate frequency of sensitisation effects in humans or low to moderate potency in animals can be presumed to produce sensitisation in humans and are classified in Category 1B according to CLP regulation 1272/2008. 4,4'-Methylenedicyclohexanamine falls into this category.
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