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Diss Factsheets
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EC number: 204-683-8 | CAS number: 124-13-0
- 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:
- Not documented
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The published study information describes a valid procedure for assessment of sensitising potential, cross referenced to various similar materials (common group of aldehydes). Some of the materials tested in the study are used as positive control materals for guideline compliant sensitisation assays, and the positive results obtained in this publication validate the published method to some degree.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin Reaction Induced by Aldehydes for Food Flavouring Agents
- Author:
- Watanabe, K. Matsuda, M. Furuhashi, S. Kimura, T. Matsunga, T. Yamamoto, I.
- Year:
- 2 001
- Bibliographic source:
- Journal of Health Science, 47 (3) 327-329 (2001)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- n-octanal was dissolved in saline containing 1% Tween 80. For sensitization, the animals were injected with 0.1 ml of n-octanal solution (1.0%) intracutaneously on both sides of the abdomen for 7 days. Three weeks later, elicitation experiments were carried out with an injection of 0.1 ml of 0.25, 0.5% and 1.0% n-octanal solution or saline containing I% Tween 80 as the control. The abdomen of each animal was depilated with a hair remover prior to the elicitation of a skin reaction. Skin reactions were graded based on reaction diameter 24 hr after the injection of n-octanal or the control as follows:
0 to 1.0 mm -,
1.0 to 2.0 mm ±,
2.0 to 4.0 mm +,
4.0 to 6.0 mm ++,
6.0 to 8.0 mm +++. - GLP compliance:
- not specified
- Type of study:
- other: Guinea pig sensitisation
- Justification for non-LLNA method:
- The test was performed in 2001 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".“
Test material
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Sankyo Laboratory ( Toyama, Japan)
- Age at study initiation: 8 weeks old
- Weight at study initiation: 300-400g
- Housing: Not documented
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not documented
ENVIRONMENTAL CONDITIONS
No details provided
IN-LIFE DATES: From: To: Not documented - paper published in February 2001
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 1% Tween 80
- Concentration / amount:
- induction 1%
challenge 0.25%, 0.5% and 1.0%
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 1% Tween 80
- Concentration / amount:
- induction 1%
challenge 0.25%, 0.5% and 1.0%
- No. of animals per dose:
- 3-4 animals were used per group and 3 animals were used for the control group.
- Details on study design:
- No further information provided
- Challenge controls:
- Control animals received 0.1 ml of saline-I % Tween 80 solution intracutaneously.
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- No information
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.25%
- No. with + reactions:
- 3
- Total no. in group:
- 3
- Clinical observations:
- reactions fron + to +++ observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.25%. No with. + reactions: 3.0. Total no. in groups: 3.0. Clinical observations: reactions fron + to +++ observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 3
- Clinical observations:
- reactions from ++ to +++ observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 3.0. Clinical observations: reactions from ++ to +++ observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 3
- Total no. in group:
- 3
- Clinical observations:
- All +++ reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0%. No with. + reactions: 3.0. Total no. in groups: 3.0. Clinical observations: All +++ reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- reactions from - to ± observed
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Skin Reaction Induced by n-Octanal
Concentration of n-Octanal used for Skin Reaction
|
||||
Animal number |
0 (Saline-Tween 80) |
0.25% |
0.5% |
1.0% |
1 |
- |
+ |
++ |
+++ |
2 |
- |
++ |
++ |
+++ |
3 |
± |
+++ |
+++ |
+++ |
- 0 to 1.0mm
± 1.0 to 2.0mm
+ 2.0 to 4.0mm
++ 4.0 to 6.0mm
+++ 6.0 to 8.0mm
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- n-octanal elicited an allergic response in three guinea pigs tested in an intracutaneous test and as such, was considered to be a potential skin sensitiser
- Executive summary:
In this study, Guinea pigs were sensitised intracutaneously on both sides of the abdomen for 7 days at a concentration of 0.1 ml of 1% n-octanal/day. Three weeks later n-octanal was injected intracutaneously to 12 male guinea pigs per test and control group at a concentration of 0.1%, 0.5% and 1.0% of n-octanal. Control animals received 0.1 ml of saline-I % Tween 80 solution intracutaneously instead of the n-octanal solution. At the test concentrations used in this study, the test substance did elicit allergenic responses and as such, is considered to be a potential skin sensitiser.
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