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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1982-03-17 to 1983-07-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study with detailed description of the method and the observations similar to guideline OECD 414
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- GLP compliance:
- not specified
- Limit test:
- yes
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:
- Teratology Screen in Rats:
- Name of test material (as cited in study report): C-259
- Substance type: white
- Physical state: liquid
- Analytical purity: no data, assumed to be 100 %
- Storage condition of test material: room temperature
Range-finding: Maternal Tolerance Study in Rats:
- Name of test material (as cited in study report): C-259
- Substance type: white
- Physical state: liquid
- Analytical purity: no data, assumed to be 100 %
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:COBS CD(SD)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS for the TERATOLOGY SCREEN IN RATS:
- Source: Charles River Breeding laboratories, Kingston, New York
- Age at delivery: five weeks
- Weight at study initiation: 230-245 g
- Fasting period before study:
- Housing: individually in elevated wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 weeks
TEST ANIMALS for the MATERNAL TOLERANCE STUDY IN RATS:
- Source: Charles River Breeding laboratories, Kingston, New York
- Age at delivery: twelve weeks
-Mating time: maximum 16 days
- Weight at study initiation: 177-285 g
- Fasting period before study: no data
- Housing: two female rats were placed with one male rat per breeding cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS FOR BOTH STUDIES:
- Temperature (°C): 70-76 °F
- Humidity (%): 57% averaged
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
weekly by weighting and dillution in water - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/2
- Length of cohabitation: max. 3 weeks
- After 10 days rotation of females.
- Further matings after two unsuccessful attempts: no
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- From day 6 through 15 of gestation
- Frequency of treatment:
- 1/day
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- Teratology Screen in Rats: 22 females
Maternal Tolerance Study in Rats: 6 females per group - Control animals:
- other: treated with corn oil
- Details on study design:
- - Dose selection rationale:
The dose of 400 mg/kg was based on a preliminary "maternal tolerance study in rats" conducted at the same laboratory. (Project number: 299-533. In this preliminiary study dose levels were 40 , 200 and 400 mg/kg.
Reported effects: The mean values of food and water consumption in all dose groups were significantly higher but did not result in an higher body weights. Gross pathology lesions were reported in three rats at 40 mg/kg (1 rat with red or bright red areas in the lung, in 1 rat the kidney contained white fluid and 1 rat with distened uterus), in one rat at 200 mg/kg (1 rat with red or bright red areas in the lung ) and in two rats at 400 mg/kg (1 rat with red or bright red areas in the lung, in 2 rats the kidney contained white fluid and in 1 rat the kidney contained tan fluid ).
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: day 0, 6, 9, 12, 15, and 20 of gestation
FOOD CONSUMPTION: Yes
- Time schedule for examinations: 6-8, 9-11, 12-14, 15-17 and 18-20
WATER CONSUMPTION: Yes
- Time schedule for examinations: 6-8, 9-11, 12-14, 15-17 and 18-20
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Details: gross examination of each dam - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: one third per litter
- Skeletal examinations: Yes: two thirds per litter
- Head examinations: no data - Statistics:
- comprehensive statistics were perfomed with the raw data
- Indices:
- no indices were calculated
- Historical control data:
- not given in the report
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
statistically significantly (after rank transformation) increased mean foof consumption values were noted on day 9 and 18
consistently increased water consumption
Gross pathology: 19 of 22 animal had no observable gross pathology. 1 rat with renal plevis dilated, 1 rat wit cystic areas in the ovary, 1 rat with tan areas in the liver
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOEL
- Effect level:
- 400 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 400 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 400 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Gross pathology: In the control group 169 out of 191 fetuses appeared normal, in the treated group this was the case for 155 out of 165 fetuses.
visceral anomalies: none
skeletal anomalies: none
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Acetaldehyde has to be considered as not teratogenic under the reported conditions. It did not induce maternal or developmental toxic effects. The NOAEL derived from this study is greater than 400 mg/kg bw/d.
- Executive summary:
Acetaldehyde was investigated for teratogenic effects in 22 rats after oral administraton of 400 mg/kg bw /d from day 6 through 15 of gesation. The dose selection was based on a maternal tolerance study. It did not induce maternal or developmental toxic effects under the reported conditions. The NOAEL derived from this study is greater than 400 mg/kg bw/d.
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