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EC number: 272-032-5 | CAS number: 68649-48-9
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13 - Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- There were positive control results
- Key result
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% w/v
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25% w/v. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Key result
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% w/v
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25% w/v. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Key result
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- other: Challenge control
- Dose level:
- 25% w/v
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: other: Challenge control. Dose level: 25% w/v. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- other: Challenge Control
- Dose level:
- 25% w/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: other: Challenge Control. Dose level: 25% w/v. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: rechallenge control
- Dose level:
- 20% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: rechallenge control. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: rechallenge control
- Dose level:
- 20% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: rechallenge control. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: rechallenge control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: rechallenge control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: rechallenge control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: rechallenge control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test there is no significant difference in the dermal response after the challenge or rechallenge applications of the test material. The test material was determined to be not sensitising and therefore does not require classification according to Regulation (EC) 1272/2008.
- Executive summary:
In a GLP compliant Buehler test, the skin sensitisation potential was assessed according to OECD guideline 406. Twenty Guinea pigs were exposed to the test material first using three induction exposures at 50 and 40 % w/v, then in a challenge and rechallenge exposure at 25, 20 and 10 % w/v. None of the test animals’ displayed a dermal reaction greater than the challenge control during the challenge or rechallenge. Under the conditions of the test, the test material was determined to be not sensitising and therefore does not require classification according to Regulation (EC) 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The key study (Rodabaugh, 2001) is a GLP compliant study which was performed in line with standardised guidelines with a sufficient level of detail to assess the quality of the study. The skin sensitisation was determined in vivo according to the Buehler test. Under the conditions of the test none of the animals displayed a dermal reaction greater than the control in either the challenge or rechallenge, thus the test material was determined to be non-sensitising. The study was performed to a good standard and was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1997).
Migrated from Short description of key information:
The potential for hydrocarbon waxes to cause skin sensitisation was determined according to a GLP compliant study (Rodabaugh, 2001) performed according to the standardised guidelines OCED 406 and EPA OPPTS 870.2600.
Justification for classification or non-classification
SKIN SENSITISATION
The guinea pig skin sensitisation study indicates that the test material is a non sensitizer and exposure does not result in any classifiable effects. Therefore the material does not require classification in line with Regulation (EC) 1272/2008.
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