Registration Dossier
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EC number: 701-281-9 | CAS number: -
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 January to 18 August 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report Date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): "3-hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde"
- Molecular formula (if other than submission substance): C5H10O3
- Physical state: Colourless, high viscous
- Composition of test material, percentage of components: ~ 82 % Dimethylpropanale, ~ 10 % Hydroxyethanesulfonic acid, Na-salt (CAS No.: 870-72-4), ~ 6 % water, ~ 2 % Potassiumformiate (CAS No.: 590-29-4)
- Lot/batch No.: CH 138067/001
- Expiration date of the lot/batch: 30 November 2010
- Stability under test conditions: Min. 1 year
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals and environmental conditions:
- Species, strain: Rats, Crl:CD(SD).
Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.
Number and sex: 6 females.
Age: Approx. 8 weeks at the time of the administration.
Health conditions: A health inspection was performed prior to the commencement of treatment to ensure that the animals were in a good state of health.
Hygiene: Optimal hygienic conditions.
Room number: EI1-11.
Room temperature: Ranges from 22 °C +/- 3 °C (continuous control and recording).
Relative humidity: Ranges from 30 - 70 % (continuous control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
Bedding material: Aspen wood chips, Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved. Random samples of the bedding material are analysed for contaminants by the supplier. Changes 1 / week.
Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week.
Feed: Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff.
Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
Water: Tap water from an automatic watering system, ad libitum. Random samples of the water are analysed by the "AGES", A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.
Identification: Labelling with felt-tipped pen on the tail and on the cage.
Acclimatisation: At least 7 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionised
- Details on oral exposure:
- A peroral administration was performed once in the morning by stomach intubation using a metal gavage.
Vehicle: deionised water.
Dose volume: 10 mL per kg body weight.
Justification: The test substance was sufficeiently soluble in water and water shalll be used pfeferagly, according to the guiedelines.
The solutions were prepared freshly before administration and were administered within 10 minutes after the preparation.
The selection of the starting dose was based on available data on the acute toxicity of a 50 % solution of the test substance, submitted by the sponsor (LD50 > 2000 mg/kg) and on the results of a dose range finding study for a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (internal study code ZSI32), where all animals survived a dose of 1000 mg/kg given on 7 consecutive days.
Therefore a LD50, oral > 2000 mg/kg was assumed.
The further proceeding was in accordance with the guideline/directive:
• Step 1: 2000 mg per kg body weight.
• Step 2: 2000 mg per kg body weight. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step (6 females per dose)
- Control animals:
- no
- Details on study design:
- Observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 14 days. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Body weights were determined
• before administration.
• 7 days p.a.
• 14 days p.a.
Body weight gain was calculated for each week of the study, i.e. between
• 0 and 7 days p.a.
• 7 and 14 days p.a.
The animals were sacrificed by inhalation of 80 % CO2 + 20 % air 14 days p.a. and subjected to a necropsy including a gross pathological examination.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- All animals showed signs of reduced well-being from 1 h until 6 h p. a. This term encompasses unspecific alterations, like sedation, apathy, piloerection, hunched posture or closed eyes, in single or multiple occurrence.
- Body weight:
- All animals gained weight in both weeks p.a.
- Gross pathology:
- No abnormal findings were made in all animals at the necropsy 14 d p.a.
Any other information on results incl. tables
Table: Body weights and body weight gain
Individual data, means and standard deviations SD.
Dose | Animal | Body weight (g) | Body weight gain (g) | ||||
mg/kg (Step No.) | No. | before | 7 days | 14 days | death | 0-7 days | 7-14 days |
2000 | 21 | 193 | 208 | 223 | - | 15 | 15 |
(1) | 22 | 189 | 230 | 233 | - | 41 | 3 |
| 23 | 188 | 217 | 235 | - | 29 | 18 |
| mean | 190.0 | 218.3 | 230.3 | - | 28.3 | 12.0 |
| SD | 2.6 | 11.1 | 6.4 | - | 13.0 | 7.9 |
2000 | 24 | 187 | 214 | 232 | - | 27 | 18 |
(2) | 25 | 183 | 210 | 221 | - | 27 | 11 |
| 26 | 187 | 214 | 230 | - | 27 | 16 |
| mean | 185.7 | 212.7 | 227.7 | - | 27.0 | 15.0 |
| SD | 2.3 | 2.3 | 5.9 | - | 0.0 | 3.6 |
Table: Observations in life
A grade of severity was recorded where applicable (low - mid - high).
Findings | Dose | Animal Nos. | Observation time |
signs of reduced well-being | 2000, 1 | 21, 22, 23 | 1 h / 6 h |
| 2000, 2 | 24, 25, 26 | 1 h / 6 h |
Table: Necropsy findings
Number of animals examined: 6 females.
SYSTEM | Dose | Step No. | Animal Nos. |
no abnormal findings | 2000 | 1 | 21, 22, 23 |
| 2000 | 2 | 24, 25, 26 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Commission Directive 2001/59/EC "3-hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde" does not require classification for acute oral toxicity.
- Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance after a single peroral administration to rats.
Methods
Methods and investigations were performed in conformance with the OECD-Guideline 423, 17 December 2001 and theCouncil Regulation (EC) No 440/2008,Method B.1 tris.
Administration of the test substance
"3-hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde"was administered once orally via gavage as a solution in deionised water to female Crl:CD(SD) rats.
The dosing was performed sequentially to groups of 3 animals per step using a starting dose 2000 mg per kg body weight.
The dose volume was 10 mL per kg body weight for all groups.
Investigations
· Body weights: before administration, 7 and 14 days after the administration (p.a.).
· Clinical observations: at least once per day.
· Necropsy: The animals were sacrificed and necropsied 14 days p.a.
Results
Dose
(mg/kg)Step No.
No. of animals
Prominent findings
exposed
affected
deceased
in life
post mortem
2000
1
3
3
0
signs of reduced well-being
none
2000
2
3
3
0
signs of reduced well-being
none
Presence of signs in life
from 1 h until 6 h p.a.
Full recovery of the animals
yes
Body weights
all animals gained weight in both weeks p.a.
Findings in life and post mortem indicate
no severe toxic effects present
LD50, oralaccording to OECD
> 5000 mg/kg body weight
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