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EC number: 200-836-8 | CAS number: 75-07-0
- 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:
- key study
- Study period:
- 1998-09-21 to 1999-02-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- and 96/54/EEC,B6
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vitro LLNA test was not available at the time the study was conducted.
Test material
- Reference substance name:
- Acetaldehyde
- EC Number:
- 200-836-8
- EC Name:
- Acetaldehyde
- Cas Number:
- 75-07-0
- Molecular formula:
- C2H4O
- IUPAC Name:
- acetaldehyde
- Details on test material:
- - Name of test material (as cited in study report): acetic aldehyde
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: 99.5%
- Lot/batch No.: not given
- Expiration date of the lot/batch: indefinitely under nitrogen and opaque container
- Storage condition of test material: In the original container in the refrigator away from direct sunlight, under nitrogen.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm:GOHI (Himalayan spotted)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 348-374
- Housing: Individually in Macrolon type 4 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 36-79%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone
- Concentration / amount:
- see details on study design
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- see details on study design
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: YES, 2 animals
MAIN STUDY
A. INDUCTION EXPOSURE
Test group:
First stage - Intradermal three pairs of intradermal injections at the flanks of the animals: 0.1 mL of a 5% dillution of the test article in acetone and 0.1 mL of a 5% dillution of the test article in Freund's complete adjuvant/physiological saline (1:1) and 0.1 mL of a 50% dillution of Freund's complete adjuvant in pysiological saline
Second stage on day 8 - dermal application at the shoulder of the animals: 50 % in acetone over an area 4x2cm for 48 h
Control group:
First stage - Intradermal three pairs of intradermal injections: 0.1 mL of acetone and 0.1 mL of a 50% dillution of Freund's complete adjuvant in pysiological saline and 0.1 mL of a 50% dillution of Freund's complete adjuvant in pysiological saline.
Second stage on day 8 - dermal application: acetone over an area 4x2cm.
Positive control group:
First stage - Intradermal three pairs of intradermal injections at the flanks of the animals: 0.1 mL of a 5% dillution of alpha-Hexylcinnamaldehyde in PEG 400 and 0.1 mL of a 5% dillution of alpha-Hexylcinnamaldehyde in Freund's complete adjuvant/physiological saline (1:1) and 0.1 mL of a 50% dillution of Freund's complete adjuvant in pysiological saline
Second stage on day 8 - dermal application at the shoulder of the animals: 50 % of alpha-Hexylcinnamaldehyde in PEG 400 over an area 4x2cm for 48 h
- Evaluation (hr after challenge): Reaction sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing
B. CHALLENGE EXPOSURE
- Test group:
Two patches (2x2 cm) were saturated with acetic aldehyde at the highest non irritation concentration of 25% (left flank) and the vehicle only (right flank). The occlusive dressing was left for 24 hours.
- Control group:
Four patches of filter paper (2x2 cm) were used in the control group. One saturated with acetic aldehyde at the highest non irritation concentration of 25% (left cranial flank), one with alpha-Hexylcinnamaldehyde (5% in PEG 400 on the left caudal flank and 1% in PEG 400 on th right cranial flank) and one with with the vehicle only (right caudal flank). The occlusive dressing was left for 24 hours.
Positive Control group: Two patches were used with alpha-Hexylcinnamaldehyde (5% in PEG 400 on the left caudal flank and 1% in PEG 400 on th right cranial flank)
- Evaluation (hr after challenge): Reaction sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing accordin to DRAIZE - Challenge controls:
- see details on test design
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Very slight to moderate/severe erythematous reactions were observed at the 24- and 48 hour reading in eight out of 10 animals when treated with alpha-Hexylcinnamaldehyde at 5% in PEG 400. Very slight oedema was also observed in two animal at the same reading time. With 1% in PEG 400 only slight edema in 5/10 animals were observed.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in acetone
- 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: 25% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in acetone
- 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: 25% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- adjuvant and saline 1:1
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- adjuvant and saline 1:1
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% alpha-hexylcinnamaldehyde in PEG 400
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% alpha-hexylcinnamaldehyde in PEG 400
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Acetaldehyde has no sensitizing potential under the conditions described in this report.
- Executive summary:
In order to assess the cutaneous allergenic potential of acetaldehyde, the Guinea Pig Maximization Test according to OECD 406 was carried out in 30 female guinea pigs. The intradermal induction of sensitisation was performed with 5% dilution of Acetaldehyde in acetone and in an emulsion of Freund's Complete Adjuvant/physiological saline . The epidermal induction of sensitization was conducted under occlusion with acetaldehyde at 50% in acetone. Two weeks after the epidermal induction application the callenge was completed by epidermal application of the test item at 25% in acetone under occlusive dressing. The animal of the control group were induced with acetone and Freund's Complete Adjuvant/physiological saline and callenged similarly to those of the test group. Cutaneous reactions, ie erythema and eschar, as well as oedema formation were evaluated at 24 and 48 hours after the removal of the dressing. Neither the test group nor the control group erythematous reactions were obsered. The positve control group that was treated with the known sensitizer alpha-Hexylcinnamaldehyde did show the expected reaction from slight to severe edemas. Therefore, acetaldehyde is considered not to be a sensitizer under the conditions of the test.
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