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EC number: 213-367-9 | CAS number: 939-97-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Older proprietary study conducted prior to development of the guidelines, methodology not fully reported
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Intradermal FCA test in guinea pigs
- GLP compliance:
- no
- Type of study:
- Freund's complete adjuvant test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No further details.
- Route:
- intradermal
- Vehicle:
- other:
- Concentration / amount:
- Induction: 5% emulsion in Freund's complete adjuvant (FCA)
Challenge: 0.1, 0.3, 1, 3 and 10% in ethanol - Route:
- epicutaneous, open
- Vehicle:
- other:
- Concentration / amount:
- Induction: 5% emulsion in Freund's complete adjuvant (FCA)
Challenge: 0.1, 0.3, 1, 3 and 10% in ethanol - No. of animals per dose:
- 6 animals per dose
- Details on study design:
- Induction: five intradermal injections of 0.1 ml of a 5% emulsion in FCA (0.05 ml FCA plus 0.05 ml test material) were made into the neck of the guinea pigs on Days 0, 2, 4, 7 and 9. Controls were treated with 0.05 ml FCA only.
Challenge: 0.025 ml was administered epicutaneously at 0.1, 0.3 and 1% on Day 35, or 3 and 10% on Day 21. - Challenge controls:
- No information.
- Positive control substance(s):
- not specified
- Positive control results:
- Not applicable.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 1%. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 0.3%. No with. + reactions: 3.0. Total no. in groups: 6.0.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 6.0.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material showed sensitising properties.
- Executive summary:
A study was conducted in groups of 6 guinea pigs to determine the skin sensitising potential of p-tert-butylbenzaldehyde. A 5% emulsion of the test material in Freund's complete adjuvant (FCA) was injected (0.1 ml) intradermally into the neck of the guinea pigs on days 0, 2, 4, 7 and 9. Controls received 0.05 ml FCA. Test animals were challenged with an epicutaneous dose of the test material (0.025 ml) on Days 21 and 35, the reactions were read after 48 and 72 hours. Doses at challenge were 10%, 3%, 1%, 0.3% or 0.1%. A 100% sensitisation rate was seen at 10, 3 and 1%, and 50% rate was seen at 0.3% and a 0% rate was seen at 0.1%. It was concluded that the test material shows sensitising properties and is a moderate intradermal sensitiser.
Reference
Under the conditions of the study, the test material showed sensitising properties.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
p-tert-butylbenzaldehyde was shown to be a moderate skin sensitiser in the intradermal Freund's complete adjuvant test in guinea pigs. However it should be noted that the substance was not sensitising in the open epicutaneous test in guinea pigs conducted at the same laboratory.
Migrated from Short description of key information:
p-tert-butylbenzaldehyde was shown to be a skin sensitiser in the intradermal Freund's complete adjuvant test; a negative results is obtained in an open epicutaneous test performed by the same authors.
Justification for selection of skin sensitisation endpoint:
Older proprietary study conducted prior to guideline development, however the results indicate that the substance has skin sensitising properties. Another study performed to a different method does not indicate any sensitisation potential.
Justification for classification or non-classification
On the basis of the positive results observed in the FCA study, p-tert-butylbenzaldehyde should be classified as a skin sensitiser according to Regulation (EC) No 1272/2008.
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