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Diss Factsheets
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EC number: 268-706-3 | CAS number: 68133-79-9
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 29 - May 13, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The analog substance has a very similar chemical structure to the substance being registered. The reported substance has a C8 carbon chain with two methyl groups and two double bonds, and the analog substance has a C9 carbon chain with two methyl groups and two double bonds in the same positions.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Both the source and target substances were tested in very pure forms. The target substance was tested at 100% purity, and the source substance was tested at 99% purity with 1% tocopherol added as a preservative.
3. ANALOGUE APPROACH JUSTIFICATION
These results provide further justification that the target substance is non-toxic.
4. DATA MATRIX
Acute oral LD50 of target substance: > 5,000 mg/kg bw.
Acute oral LD50 of source substance: > 5,000 mg/kg bw.
Acute dermal LD50 of source substance: > 5,000 mg/kg bw.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2-(3,7-dimethyl-2,6-nonadien-1-yl)-cyclopentane
- Cas Number:
- 1206769-45-0
- Molecular formula:
- C16H26O
- IUPAC Name:
- 2-(3,7-dimethyl-2,6-nonadien-1-yl)-cyclopentane
- Reference substance name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
- EC Number:
- 233-466-0
- EC Name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
- Cas Number:
- 10191-41-0
- Molecular formula:
- C29H50O2
- IUPAC Name:
- 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-6-ol
- Test material form:
- liquid
Constituent 1
additive 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Born on January 2, 2010
- Weight at study initiation: 2.3-2.8 kg males, 2.6-2.9 females
- Housing: individually in suspended wire cages
- Diet (e.g. ad libitum): PMI Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: April 29, 2010 To: May 13, 2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10% of body area
- Type of wrap if used: gauze dressing with semi-occlusive plastic sheeting
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 12.8 - 16.1 mL to create dose of 5,000 mg/kg bw
- Concentration (if solution): 100% - Duration of exposure:
- 24 hrs
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Toxicity and pharmacological effects - 1, 2, and 4 hrs postdose, and daily until 14 days; mortality - twice daily; Weighings - pretest, day 7 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: All animals showed skin reactions by 24 hrs after exposure, with erythema scores of up to 3 and edema scores of up to 2. By day 7, one animal showed no signs of skin irritation, but all other animals showed signs of irritation such as cracking skin, flak
- Gross pathology:
- Normal except for skin abnormalities.
Any other information on results incl. tables
Dermal Observations
Animal |
Erythema – 24 hrs |
Edema – 24 hrs |
Erythema – Day 7 |
Edema – Day 7 |
Erythema – Day 14 |
Edema – Day 14 |
H3245 |
2 |
1 |
Eschar, flaking skin, cracking skin |
1 |
Poor hair regrowth, flaking skin |
0 |
H3246 |
2 |
1 |
0 |
0 |
Flaking skin |
0 |
H3247 |
2 |
2 |
Eschar, flaking skin, cracking skin |
0 |
Flaking skin, poor hair regrowth, shiny areas |
0 |
H3249 |
2 |
1 |
>4 moderate eschar, cracking skin, flaking skin |
2 |
Flaking shin, poor hair regrowth |
0 |
H3250 |
2 |
0 |
Cracking skin, flaking skin, eschar |
1 |
Flaking skin, poor hair regrowth |
0 |
H3272 |
3 |
1 |
Cracking skin, flaking skin, eschar |
0 |
Flaking skin, poor hair regrowth |
0 |
H3273 |
2 |
2 |
Cracking skin |
0 |
Flaking skin, poor hair regrowth, shiny areas |
0 |
H3274 |
2 |
1 |
Cracking skin, flaking skin |
0 |
Flaking skin |
0 |
H3275 |
2 |
0 |
Cracking skin, flaking skin |
0 |
Flaking skin |
0 |
H3276 |
2 |
1 |
Flaking skin |
0 |
Flaking skin |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of methyl apritone in rabbits is > 5000 mg/kg bw.
- Executive summary:
The dermal toxicity of methyl apritone was determined by exposing 10 rabbits to 5000 mg/kg bw of the substance for 24 hrs. After 24 hrs of exposure, the test substance was removed, and the animals observed for 14 days. Although signs of skin irritiation were noted, no animals died during the study. The acute dermal LD50 of the substance is therefore > 5000 mg/kg bw.
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