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EC number: 259-461-3 | CAS number: 55066-48-3
- 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:
- 1980-04-05 to 1980-04-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed in compliance with GLP, and to a method similar to the standardised guideline OECD 402. Some deficiencies were present in the of the study, such as no methods to prevent the animals from ingesting the test material, a massive sensitivity difference between sexes and a lack of vehicle controls.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- (no prevention of the animals ingesting the test material)
- GLP compliance:
- yes
- Remarks:
- Federal Register, Volume 43, No. 247
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-methyl-5-phenylpentanol
- EC Number:
- 259-461-3
- EC Name:
- 3-methyl-5-phenylpentanol
- Cas Number:
- 55066-48-3
- Molecular formula:
- C12H18O
- IUPAC Name:
- 3-methyl-5-phenylpentan-1-ol
- Test material form:
- other: liquid (not specified)
- Details on test material:
- - Physical state: Liquid, clear, colourless
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: Young adult
- Weight at study initiation: Within the weight range of 180 to 280 grams
- Housing: Individually housed in wire cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 7 days
IN-LIFE DATES: From: 1980-04-05 To: 1980-04-19
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: alcohol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The back, from the scapular region to the hips
- % coverage: Less than 30%
- Type of wrap if used: The site was left open to the air
REMOVAL OF TEST SUBSTANCE
- Washing: Any excess material was removed by wiping with a clean cloth
- Time after start of exposure: 24 hours post dosing.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL/100 g bw - Duration of exposure:
- 24 hours
- Doses:
- 2000, 2500, 3100, 4000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 8 males and 8 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period. All animals were weighed prior to dosing.
- Necropsy of survivors performed: All the animals underwent a gross necropsy at the end of the experiment. the animals were killed using ether inhalation. - Statistics:
- Probit analysis was performed using the method of Litchfield JT Jr & Wilcoxon F (1949) A Simplified Method of Evaluating Dose-Effect Experiments; J. Pharm. Exp. Therap., 96:99-115.
Results and discussion
- Preliminary study:
- Two rats of either sex were used. Each animal received a single dose of the test article, and was observed for the next 72 hours to determine the mortality only. The doses administered were 2400 and 5000 mg/kg bw. No animals died during the 72 hour observation period following dosing at 2500 mg/kg bw. All four rats died within 24 hours after being dosed at 5000 mg/kg bw.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 100 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality was low in the male groups with only one of eight rats dead at 3100 and 5000 mg/kg bw. The females exhibited lethality as follows: 1/8 at 2500 mg/kg bw; 4/8 at 3100 mg/kg bw; 5/8 at 4000 mg/kg bw and 8/8 at 5000 mg/kg bw.
- Clinical signs:
- other: Clinical signs were first noted at 2500 mg/kg bw in the female rats and 3100 mg/kg bw in the male rats. The signs were of lethargy, ataxia, tremors and soft faeces; one female died on Day 3. At higher doses, the clinical signs included ataxia, lethargy, h
- Gross pathology:
- At necropsy, none of the animals that survived to term had any specific signs indicative of systemic toxicity. The predominant signs in animals that died during the study were hematuria in females at 5000 mg/kg bw and a change to greater fluidity in the consistency of the intestinal contents.
Any other information on results incl. tables
Table 1: Body weights and doses administered
MALES |
||||||||||
2000 mg/kg bw | Animal No. | 2705 | 2706 | 2707 | 2708 | 2709 | 2710 | 2711 | 2712 | Mean |
Vol test material administered (mL) | 1.1 | 1.1 | 1.3 | 1.2 | 1.1 | 1.1 | 1.1 | 1.1 | ||
Pre-dose body weight (g) | 225 | 222 | 262 | 236 | 218 | 215 | 220 | 218 | 227.0 | |
Terminal body weight (g) | 314 | 309 | 349 | 316 | 316 | 330 | 344 | 303 | 322.6 | |
Gain/Loss (g) | +89 | +87 | +87 | +80 | +98 | +115 | +124 | +85 | +95.6 | |
2500 mg/kg bw | Animal No. | 2713 | 2714 | 2715 | 2716 | 2717 | 2718 | 2719 | 2720 | Mean |
Vol test material administered (mL) | 1.3 | 1.1 | 1.1 | 1.2 | 1.3 | 1.3 | 1.2 | 1.2 | ||
Pre-dose body weight (g) | 262 | 228 | 226 | 234 | 256 | 251 | 240 | 246 | 242.9 | |
Terminal body weight (g) | 350 | 308 | 319 | 310 | 353 | 308 | 320 | 327 | 324.4 | |
Gain/Loss (g) | +88 | +80 | +93 | +76 | +97 | +57 | +80 | +81 | +81.5 | |
3100 mg/kg bw | Animal No. | 2721 | 2722 | 2724 | 2725 | 2726 | 2728 | 2729 | 2730 | Mean |
Vol test material administered (mL) | 1.3 | 1.3 | 1.2 | 1.2 | 1.2 | 1.3 | 1.3 | 1.2 | ||
Pre-dose body weight (g) | 253 | 258 | 238 | 241 | 246 | 258 | 250 | 239 | 247.9 | |
Terminal body weight (g) | 330 | 306 | D | 324 | 306 | 355 | 360 | 338 | 331.3 | |
Gain/Loss (g) | +77 | +48 | - | +83 | +60 | +97 | +110 | +99 | +82.0 | |
4000 mg/kg bw | Animal No. | 2679 | 2680 | 2681 | 2682 | 2683 | 2684 | 2685 | 2686 | Mean |
Vol test material administered (mL) | 1.1 | 1.1 | 1.2 | 1.1 | 1.2 | 1.1 | 1.2 | 1.3 | ||
Pre-dose body weight (g) | 215 | 216 | 244 | 227 | 232 | 212 | 230 | 252 | 228.5 | |
Terminal body weight (g) | 301 | 306 | 312 | 290 | 319 | 291 | 293 | 317 | 303.6 | |
Gain/Loss (g) | +86 | +90 | +68 | +63 | +87 | +79 | +63 | +65 | +75.1 | |
5000 mg/kg bw | Animal No. | 2687 | 2688 | 2689 | 2690 | 2691 | 2692 | 2693 | 2694 | Mean |
Vol test material administered (mL) | 1.1 | 1.2 | 1.2 | 1.1 | 1.2 | 1.3 | 1.2 | 1.2 | ||
Pre-dose body weight (g) | 216 | 226 | 222 | 220 | 238 | 254 | 240 | 234 | 231.3 | |
Terminal body weight (g) | 284 | 275 | D | 318 | 308 | 280 | 300 | 301 | 295.1 | |
Gain/Loss (g) | +68 | +49 | - | +98 | +70 | +26 | +60 | +67 | +62.6 | |
FEMALES |
||||||||||
2000 mg/kg bw | Animal No. | 2862 | 2863 | 2864 | 2865 | 2866 | 2867 | 2868 | 2869 | Mean |
Vol test material administered (mL) | 1.2 | 1.1 | 1.2 | 1.3 | 1.2 | 1.3 | 1.1 | 1.0 | ||
Pre-dose body weight (g) | 249 | 227 | 232 | 260 | 240 | 250 | 215 | 208 | 235.1 | |
Terminal body weight (g) | 259 | 211 | 230 | 253 | 261 | 271 | 234 | 228 | 243.4 | |
Gain/Loss (g) | +10 | -16 | -2 | -7 | +21 | +21 | +19 | +20 | +8.3 | |
2500 mg/kg bw | Animal No. | 2870 | 2871 | 2872 | 2873 | 2874 | 2875 | 2876 | 2877 | Mean |
Vol test material administered (mL) | 1.1 | 1.2 | 1.3 | 1.2 | 1.0 | 1.2 | 1.1 | 1.2 | ||
Pre-dose body weight (g) | 224 | 238 | 250 | 247 | 200 | 239 | 223 | 230 | 231.4 | |
Terminal body weight (g) | 247 | 242 | D | 282 | 212 | 246 | 226 | 239 | 242.0 | |
Gain/Loss (g) | +23 | +4 | - | +35 | +12 | +7 | +3 | +9 | +13.3 | |
3100 mg/kg bw | Animal No. | 2878 | 2879 | 2880 | 2881 | 2882 | 2883 | 2884 | 2885 | Mean |
Vol test material administered (mL) | 1.1 | 1.0 | 1.1 | 1.2 | 1.3 | 1.1 | 1.1 | 1.1 | ||
Pre-dose body weight (g) | 223 | 204 | 226 | 238 | 254 | 226 | 225 | 220 | 227.0 | |
Terminal body weight (g) | D | D | D | 261 | 263 | D | 239 | 222 | 246.3 | |
Gain/Loss (g) | - | - | - | +23 | +9 | - | +14 | +2 | +12.0 | |
4000 mg/kg bw | Animal No. | 2854 | 2855 | 2856 | 2857 | 2858 | 2859 | 2860 | 2861 | Mean |
Vol test material administered (mL) | 1.2 | 1.2 | 1.2 | 1.2 | 1.1 | 1.1 | 1.1 | 1.2 | ||
Pre-dose body weight (g) | 236 | 232 | 238 | 230 | 228 | 228 | 225 | 247 | 233.0 | |
Terminal body weight (g) | 255 | 247 | D | 225 | D | D | D | D | 242.3 | |
Gain/Loss (g) | +19 | +15 | - | -5 | - | - | - | - | +9.7 | |
5000 mg/kg bw | Animal No. | 2786 | 2787 | 2788 | 2789 | 2790 | 2791 | 2792 | 2793 | Mean |
Vol test material administered (mL) | 1.1 | 1.3 | 1.1 | 1.3 | 1.1 | 1.3 | 1.2 | 1.3 | ||
Pre-dose body weight (g) | 221 | 248 | 215 | 248 | 218 | 248 | 230 | 247 | 234.4 | |
Terminal body weight (g) | D | D | D | D | D | D | D | D | - | |
Gain/Loss (g) | - | - | - | - | - | - | - | - | - |
Table 2: Mortality
Dose (mg/kg bw) | Male | % | Female | % |
2000 | 0/8 | 0 | 0/8 | 0 |
2500 | 0/8 | 0 | 1/8 | 12.5 |
3100 | 1/8 | 12.5 | 4/8 | 50.0 |
4000 | 0/8 | 0 | 5/8 | 62.5 |
5000 | 1/8 | 12.5 | 8/8 | 100.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the dermal LD50 in albino (Sprague Dawley CD) rats was determined to be greater than 5000 mg/kg bw for males and equal to 3100 (2900 - 3320) mg/kg bw for females.
- Executive summary:
Eighty male and female albino rats (8 males and 8 females per group) were dosed dermally with the test material at concentrations of 2000, 2500, 3100, 4000 and 5000 mg/kg bw prepared in alcohol. The test site was left uncovered, after 24 hours excess material was wiped off and the animals were observed for 14 days for mortality and signs of pharmacotoxicity. The acute dermal LD50 was determined to be > 5000 mg/kg bw in males and 3100 (2900-3200 mg/kg bw) in females.
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