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EC number: 216-510-3 | CAS number: 1604-35-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD TG 423 (Acute Oral toxicity - Acute Toxic Class Method) under GLP conditions. The study is sufficient for endpoint evaluation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3,7,11-trimethyldodecyn-3-ol
- EC Number:
- 216-510-3
- EC Name:
- 3,7,11-trimethyldodecyn-3-ol
- Cas Number:
- 1604-35-9
- Molecular formula:
- C15H28O
- IUPAC Name:
- 3,7,11-trimethyldodec-1-yn-3-ol
- Details on test material:
- - Name of test material (as cited in study report): 3,7,11-trimethyldodecyn-3-ol
- Physical state: not reported
- Analytical purity: 99.0 area% (for details see analytical report No. 05L00028).
- Impurities (identity and concentrations):
- Purity test date: nor reported
- Lot/batch No.: 05-0001
- Stability under test conditions: The stability under storage conditions was confirmed by reanalysis (for details see analytical report No. 05L001 78).
- Storage condition of test material: not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HanRcc:WIST(SPF) from RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland; female animals were nulliparaus and non-pregnant
- Age at study initiation: female animais approx 8- 12 weeks)
- Weight at study initiation: ± 20% of the mean weight
- Fasting period before study: Feed was withdrawn from the animais at least 16 hours before administration, but water was available ad libitum.
- Housing: in fully air-conditioned rooms; Stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG); Single housing
- Diet: ad libitum (Kliba-Labordiät (Maus 1 Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland,)
- Water: ad libitum (Tap water)
- Acclimation period: Acclimatization for at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h /12 h (6.00 a.m. - 6.00 p.m. 1 6.00 p.m. - 6.00 a.m.)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/kg bw (10 g/100 mL substance); 2000 mg/kg bw (40 g/100 mL substance)
- Amount of vehicle (if gavage): 500 mg/kg bw (2 mL/kg); 2000 mg/kg bw (5 mL/kg)
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity of the preparation.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2,000 mg/kg bw body weight has been chosen in the first step with 3 female animals. As two of those animals died, 500 mg/kg bw were administered to 3 female animals in a second step. Because all animals survived the second step, 500 mg/kg bw have been tested in athird step with 3 female animals, finally. - Doses:
- 500 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 9 animals:
- 3 female animals at 2,000 mg/kg bw
- 6 female animais at 500 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study. Additionally, at day of death in animals that died or were sacrificed moribund starting with study day 1.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Mortality:
- - Two animais of the 2,000 mg/kg administration group were found dead on study days 3 and 5 respectively.
- No mortality occurred in the 500 mg/kg administration groups. - Clinical signs:
- other: - Clinical observation in the 2,000 mg/kg bw administration group revealed impaired and poor general state, dyspnoea, lateral position, staggering, piloerection, smeared fur, diarrhea and lacrimation and were observed from hour 2 until including study day
- Gross pathology:
- - The following macroscopic pathologic findings were observed in the animals that died: Few (2-5), black erosions/ulcers in the glandular stomach, diameter up to 4 mm (2,000 mg/kg bw: 1 female) and moderate, dark red or red discoloration of contents of small intestine (2,000 mg/kg bw: 2 females).
- No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study (2,000 mg/kg bw: 1 female; 500 mg/kg bw: 6 females). - Other findings:
- - Organ weights:
- Histopathology:
- Potential target organs:
- Other observations:
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the median lethal dose of 3,7,1 1-trimethyldodecyn-3-ol after oral administration was found to be greater than 500 mg/kg and less than 2,000 mg/kg bw in rats.
- Executive summary:
The study was conducted according to OECD TG 423 (Acute Oral toxicity - Acute Toxic Class Method) under GLP conditions. The study is sufficient for endpoint evaluation. Acute oral toxicity was tested in female Wistar rats (3 per treatment group) via gavage.
Single doses of 2,000 and 500 mg/kg bw of test material preparations in olive oil were given to three administration groups of three fasted female animals, each, (2,000 mg/kg bw in 3 females, 500 mg/kg bw in 6 females) by gavage in a sequential manner. Two animals of the 2,000 mg/kg bw administration group were found dead from study day 3 until including study day 5. No mortality occurred in the 500 mg/kg bw administration groups.
Clinical observation in the 2,000 mg/kg bw administration group revealed impaired and poor general state, dyspnoea, lateral position, staggering, piloerection, smeared fur, diarrhea and lacrimation. Findings were observed from hour 2 until including study day 3 after administration. Clinical observation in the 500 mg/kg bw administration groups revealed impaired general state, dyspnoea, staggering, piloerection and diarrhea. Findings were observed from hour 1 until including hour 5 after administration. The mean body weights of the 500 mg/kg bw administration groups increased throughout the study period. The body weight of the surviving animal of the 2,000 mg/kg bw administration group increased during the first post exposure observation week but did not increase during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
During necropsy findings in the animals that died in the 2,000 mg/kg bw administration group comprised few black erosions/ulcers in the glandular stomach and red or moderate dark red discoloration of contents of small intestine.
No macroscopic pathologic abnormalities were noted in the animals of the 500 mg/kg bw administration groups and in the surviving animal of the 2,000 mg/kg bw administration group examined at the end of the observation period.
Under the conditions of this study the median lethal dose of 3,7,1 1-trimethyldodecyn-3-ol after oral administration was found to be greater than 500 mg/kg and less than 2,000 mg/kg bw in rats.
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