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Diss Factsheets
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EC number: 203-765-0 | CAS number: 110-41-8
- 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
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity of the test substance to rats was studied in a standard acute method. The LD₅₀ was determined to be >5000 mg/kg bw.
The test material was assessed for acute dermal toxicity using rabbits. The test material was not acutely toxic to rabbits via the dermal route at a concentration of 10 mL/kg bw.
No study is available for acute inhalation toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 10 rats received doses of the test material and were observed for 14 days, then killed and autopsied. Preliminary and main studies were performed.
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Names of test material (as cited in study report): RIFM 71-16, aldehyde C-12 MNA
- Substance type: Clear liquid
- Physical state: Liquid - Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED: No data
DOSAGE PREPARATION (if unusual): No data
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data - Doses:
- Preliminary study - 316 mg/kg, 1260 mg/kg, 5000 mg/kg
Main study - 5000 mg/kg - No. of animals per sex per dose:
- Preliminary study - 2 per dose, sex not specified.
Main study - 5 males, 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No data - Statistics:
- No data
- Preliminary study:
- No mortality was observed at doses of 316 mg/kg, 1260 mg/kg or 5000 mg/kg.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: No data
- Gross pathology:
- Autopsy revealed no unusual findings.
- Other findings:
- - Organ weights: No data
- Histopathology: No data
- Potential target organs: No data - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of the test substance to rats was studied in a standard acute method. The LD50 was determined to be >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 4 rabbits were dermally exposed to the test material for 24 hr and then observed for a further 24 hours for mortality. The first attempt at this experiment was ended early; the study was repeated with 3 new rabbits.
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- - Names of test material: RIFM 71-16, aldehyde C-12 MNA
- Substance type: Clear liquid
- Physical state: Liquid - Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.6 to 3.0 kg
- Fasting period before study: No data
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod: No data - Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap: wrap described as "damming" - no further information.
REMOVAL OF TEST SUBSTANCE
- Washing: Water
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: No - Duration of exposure:
- 24 hr
- Doses:
- 10 mL/kg
- No. of animals per sex per dose:
- 2 male, 2 female (test group 1)
2 male, 1 female (test group 2) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 10 days (test group 1); 14 days (test group 2)
- Frequency of observations and weighing:
-- Test group 1: Observations every day from days 1-10; weighing on days 0, 3, 7, 10.
-- Test group 2: Observations every day from days 1-14; weighing on days 0, 3, 7, 10, 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: Body weight, skin irritation (erythema, oedema). - Statistics:
- No data
- Preliminary study:
- No preliminary study
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Equivalent to 8280 mg/kg bw when multiplied by density of 828 mg/mL.
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: See attached results. Oedema was replaced by a shell of hard peeling skin in rabbits 1A♂ and 1U♂ by day 7 (test group 1) and 8A♂ by day 6 (test group 2).
- Gross pathology:
- Autopsy revealed no unusual findings.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was assessed for acute dermal toxicity using rabbits. The test material was not acutely toxic to rabbits via the dermal route at a concentration of 10 mL/kg bw.
Multiplying this value by the density value of 828 mg/mL gives a value of 8280 mg/kg bw.
Reference
Please refer to the attached background material.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 8 280 mg/kg bw
Additional information
Acute oral toxicity
The acute oral toxicity of the test substance to rats was studied in a standard acute method on rats. No animals died during the 14-day observation period and autopsies revealed no unusual findings. The LD₅₀ was determined to be >5000 mg/kg bw.
Acute inhalation toxicity
No study is available.
Acute dermal toxicity
The test material was assessed for acute dermal toxicity using rabbits. Dermal irritation was noted. No animals died during the study and autopsy revealed no unusual findings. The test material was not acutely toxic to rabbits via the dermal route at a concentration of 10 mL/kg bw. Multiplying this value by the density value of 828 mg/mL gives a value of 8280 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
The study was performed on the test substance.
Justification for selection of acute toxicity – dermal endpoint
The study was performed on the test substance.
Justification for classification or non-classification
Based on the acute oral LD50 value of 5000 mg/kg body weight and acute dermal LD50 value of 8280 mg/kg body weight, 2 -methylundecanal does not need to be classified for acute toxicity according to the criteria outlined in Annex VI or 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
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