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EC number: 240-362-9 | CAS number: 16251-77-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- November - December 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in compliance with guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (20 animals per treatment group is recommended in the current guideline)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 3-phenylbutyraldehyde
- EC Number:
- 240-362-9
- EC Name:
- 3-phenylbutyraldehyde
- Cas Number:
- 16251-77-7
- Molecular formula:
- C10H12O
- IUPAC Name:
- 3-phenylbutanal
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ST 25C 88
- Physical state: clear colorless liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Darley Oaks, Burton-on-Trent, Staffordshire, England.
- Age at study initiation: no data available. Study cited that animals are young.
- Weight at study initiation: range of 407 to 498 g (mean of 455 g)
- Housing: Animals were housed in groups of ten in stainless steel cages fitted with mesh floors and of the approximate dimensions 85 x 57 x 25cm.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 45-68 %
- Air changes (per hr): no data available. Air conditioning was provided
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: experimental work was cited as taking place from 17-Nov-1988 to 23-Dec-1988.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: No vehicle was used in the induction phase. Ethanol was used as the vehicle in the challenge phase. Ethanol was also used as the vehicle in the preliminary irritation screening study.
- Concentration / amount:
- - Irritation screening study: 0.5 mL of the following concentrations of test material: 12.5%, 25%, 50%, 100% v/v. Solvent was ethanol. (The preliminary irritation screening assay showed no irritation effects at concentrations of 12.5%, 25%, 50% or 100% of test substance, hence the induction phase of the study used the undiluted test material).
- Main study, induction phase: 0.5 mL of undiluted test material.
- Main study, challenge phase: 0.5 mL of undiluted test material (left flank) and 0.5 mL of 50 % v/v diluted test material in ethanol (right flank).
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: No vehicle was used in the induction phase. Ethanol was used as the vehicle in the challenge phase. Ethanol was also used as the vehicle in the preliminary irritation screening study.
- Concentration / amount:
- - Irritation screening study: 0.5 mL of the following concentrations of test material: 12.5%, 25%, 50%, 100% v/v. Solvent was ethanol. (The preliminary irritation screening assay showed no irritation effects at concentrations of 12.5%, 25%, 50% or 100% of test substance, hence the induction phase of the study used the undiluted test material).
- Main study, induction phase: 0.5 mL of undiluted test material.
- Main study, challenge phase: 0.5 mL of undiluted test material (left flank) and 0.5 mL of 50 % v/v diluted test material in ethanol (right flank).
- No. of animals per dose:
- - Irritation screening study: 4 animals
- Main study, induction and challenge phase:
Test group: 10 animals
Control group: 10 animals - Details on study design:
- IRRITATION SCREENING STUDY:
- No. of exposures: 1
- Exposure period: 6 hrs
- Test groups: 1 group of 4 animals
- Control group: none
- Site: flank (no details on whether left or right)
- Evaluation: 24 and 48 hrs
- Concentrations: 0.5 mL of the following concentrations of test material: 12.5%, 25%, 50%, 100% v/v. Solvent was ethanol.
- Application: using a 2 cm square of gauze, occluded. Test site was clipped free of fur one day prior to application of the test material.
MAIN STUDY
A. INDUCTION PHASE
- No. of exposures: 3
- Exposure period: 6 hrs
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: left shoulder area
- Frequency of applications: application at day 1, day 8 and day 15
- Duration: 28 days
- Concentrations: 0.5 mL of undiluted test material
- Application: using a 2 cm square of gauze, occluded. Test site was clipped free of fur one day prior to application of the test material.
B. CHALLENGE PHASE
- No. of exposures: 1
- Day(s) of challenge: day 29
- Exposure period: 6 hrs
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: left and right flank
- Concentrations: 0.5 mL of undiluted test material (left flank) and 0.5 mL of 50 % v/v diluted test material in ethanol (right flank)
- Application: using a 2 cm square of gauze, occluded. Test site was clipped free of fur one day prior to application of the test material.
- Evaluation (hr after challenge): 24 and 48 hrs after the application. - Challenge controls:
- no data
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Undiluted and 50% test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Undiluted and 50% test material . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Undiluted and 50% test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Undiluted and 50% test material . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
No response was exhibited by any animal of the test or control group following challenge with the undiluted test material and a 50% dilution of the test material in ethanol.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information under CLP REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- Conclusions:
- There was no evidence to suggest that the test material acts as a sensitiser in the guinea pig.
- Executive summary:
A GLP-compliant study was conducted in guinea pigs to assess the skin sensitisation potential of the substance using the Buehler test. The study was conducted according to the OECD Testing Guideline No. 406. Following induction using the undiluted substance applied for 6 hours on each of days 1, 8, and 15 of the study, a challenge application of the undiluted (i.e., 100%) and diluted (50% in ethanol) substance was initiated on Day 28. Following scoring of the skin sites, it was observed that there were no responses in any of the animals at any of the test sites. Criteria for Buehler assay: a response of at least 15 % of the animals is considered positive and it means that at least one animal was observed to have a positive response in this study. Regarding irritation in the preliminary assay, concentrations of 12.5%, 25%, 50% and 100% of the substance did not elicit signs of irritation. Altogether, it was concluded that there was no evidence to indicate that the substance acts as a sensitiser in the guinea pig. Therefore, based on the results of this study, there is unlikely to be any risk of sensitisation occurring in man following repeated dermal exposure to the material.
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