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EC number: 291-768-8 | CAS number: 90480-35-6
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1.12.2016-19.12.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Adopted: 24th February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- EC Number:
- 291-768-8
- EC Name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- Cas Number:
- 90480-35-6
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)benzene; ethanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 287.1−308.3g for males and 211.1−241.9g for females
- Housing: one animal per stainless wire mesh cage
- Diet: ad libitum; pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C, Envigo RMS, Inc., U.S.A.)
- Water: ad libitum; public tap water in Cheongju-si was filtered and irradiated by ultraviolet light
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1−24.5
- Humidity (%): 45.7−63.9
- Air changes (per hr): 10−15
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied to an area of approximately 5 cm×6 cm for males and females. After the application of the test substance to a lint tape, the application site was covered with the lint tape and plastic film. Each animal’s back was over-wrapped with Soft Cloth Tape with Liner (5 cm width, 3M Co., Ltd., Republic of Korea) and surgical tape.
Dose volume: 2.24 mL/kg body weight. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males/5 females
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- RANGE FINDING STUDY
- goal: Justification for dose level
- animals: 1 male and 1 female
- dose: 2000 mg/kg
- dose volume: 2.24 mL/kg
MAIN STUDY
OBSERVATIONS
Clinical signs
All animals were observed for mortality, general condition and clinical signs (type, severity, time of onset and recovery) at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Day 1−Day 14).
Body weights
The body weights were recorded prior to dosing on Day 0 and on Days 3, 7 and on the day of necropsy, Day 14.
PATHOLOGY
Necropsy
On Day 14, all animals were anesthetized with CO2 and exsanguinated from the abdominal aorta. Complete gross postmortem examinations were performed on all animals in the study.
Histopathology
Since no gross findings were observed at necropsy, histopathological examinations were not performed. - Statistics:
- Statistical analysis was performed using SAS Program (version 9.3, SAS Institute Inc., U.S.A.). Body weights were analyzed utilizing Folded-F test for homogeneity of variance (significance level: 0.05). Student t-test was employed on homogeneous data (significance levels: 0.05 and 0.01, two-tailed).
Results and discussion
- Preliminary study:
- In a preliminary study, one male and one female rat were dermally dosed at a dose of 2000 mg/2.24 mL/kg. No deaths occurred. Therefore, the dose level was selected at 2000 mg/kg for the main study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths of animals in the 2,000 mg/kg groups.
- Clinical signs:
- other: No abnormalities of clinical signs were observed in any animal in the control groups and 2000 mg/kg groups throughout the study.
- Gross pathology:
- No grossly visible findings were observed in any animal in the control groups and 2000 mg/kg groups.
- Other findings:
- No other findings to report.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, the LD50 value of the test substance was considered to be greater than 2000 mg/kg in male and female rats under the conditions of this study.
According to the EU Regulation No. 1272/2008, the test substance does not need to be classified and has no obligatory labelling requirement. - Executive summary:
The purpose of this study was to assess the potential toxicity and the approximate LD50 value of the test substance following a single dermal application to Sprague-Dawley rats. The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity" and under GLP regulations.
Test groups consisted of one dose group at a dose of 2000 mg/kg and a control group, and each group consisted of 5 males and 5 females. All animals were monitored for clinical signs and bodyweight changes after dosing during the 14-day observation period. They were subjected to gross necropsy at the end of the observation period.
There were no deaths of animals in the 2000 mg/kg groups. No test substance-related effects were observed in clinical signs, bodyweight data or necropsy findings in the 2000 mg/kg groups.
Based on the result of this study, the LD50 is > 2000 mg/kg bw for the test substance in male and female rats and under the conditions of this study.
Hence, the substance should not be classified as acute toxic according to the criteria described in EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP).
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