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EC number: 686-822-6 | CAS number: 1200-09-5
- 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
- Study period:
- 2008-09-30 to 2008-10-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD test guideline 420
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 4-(3-methylbut-2-en-1-yl)phenol
- EC Number:
- 686-822-6
- Cas Number:
- 1200-09-5
- Molecular formula:
- C11H14O
- IUPAC Name:
- 4-(3-methylbut-2-en-1-yl)phenol
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, United Kingdom
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 156 - 187 g
- Fasting period before study: overnight before dosing
- Housing: polypropylene cages with woodflakes
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 7
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL (300 mg/kg). For 2000 mg/kg, the test material was used as supplied (undiluted)
- Amount of vehicle (if gavage): 10 mL (300 mg/kg), 2.04 mL (2000 mg/kg)
- Justification for choice of vehicle: test substance not soluble in water
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: absence of toxicity data - Doses:
- 300, 2000 mg/kg
- No. of animals per sex per dose:
- 300 mg/kg: 5
2000 mg/kg: 1 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observtions made 0.5, 1, 2 and 4 hours after dosing then daily up to day 14. Body weights were recorded on day 0, 7 and 14 after dosing (or at day of death)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
- Other: Following the sighting test at dose levels of 2000 mg/kg (one animal) and 300 mg/kg (one animal), a further group of four fasted female rats was given a single oral dose of 300 mg/kg test material due to mortality and signs of systemic toxicity at the dose level of 2000 mg/kg.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg: 1/1
300 mg/kg: 0/5 - Clinical signs:
- 2000 mg/kg: hunched posture, lethargy, ataxia, decreased respiratory rate, loss of righting reflex, laboured respiration, ptosis, hypothermia, urine stained red, killed in extremis
300 mg/kg: no signs of systemic toxicity - Body weight:
- 2000 mg/kg: 170 g
300 mg/kg: 179 - 216 g - Gross pathology:
- 2000 mg/kg: lungs abnormally red, dark liver, dark kidneys, haemorrhagic and ulcerated gastric mucosa, haemorrhagic non-glandular epithelium of the stomach
300 mg/kg: no abnormalities detected
Any other information on results incl. tables
Individual bodyweights and bodyweight changes
Dose level [mg/kg] |
Animal number and sex |
Bodyweight [g] at day |
Bodyweight [g] at death |
Bodyweight gain [g] during week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
2-0 female |
176 |
- |
- |
170 |
- |
- |
300 |
1-0 female |
156 |
166 |
179 |
- |
10 |
13 |
300 |
3-0 female |
184 |
192 |
216 |
- |
8 |
24 |
300 |
3-1 female |
187 |
197 |
203 |
- |
10 |
6 |
300 |
3-2 female |
179 |
181 |
200 |
- |
2 |
19 |
300 |
3-3 female |
187 |
199 |
200 |
- |
12 |
1 |
Individual clinical obervations and mortality data
Dose level [mg/kg] |
Animal number and sex |
Effects noted after dosing [h] |
Effects noted during period after dosing [d] |
|||
0.5 |
1 |
2 |
4 |
1 – 14 |
||
2000 |
2-0 female |
H L A Rd |
H L A Rd |
Rd Rl Rr Pt Ho U X |
- |
- |
300 |
1-0 female |
0 |
0 |
0 |
0 |
0 |
300 |
3-0 female |
0 |
0 |
0 |
0 |
0 |
300 |
3-1 female |
0 |
0 |
0 |
0 |
0 |
300 |
3-2 female |
0 |
0 |
0 |
0 |
0 |
300 |
3-3 female |
0 |
0 |
0 |
0 |
0 |
H: hunched posture; L: lethargy; A: ataxia; Rd: decreased respiration rate; Rl: laboured respiration; Rr: loss of righting reflex; Pt: ptosis; Ho: hypothermia; U: urine stained red; X: animal killed in extremis
Necropsy findings
Dose level [mg/kg] |
Animal number and sex |
Time of death [d] |
Macroscopic observations |
2000 |
2-0 female |
0 in extremis |
Lungs: abnormally red; liver: dark; kidneys: dark; gastric muscosa: haemorrhagic, ulcerated; non-glandular epithelium of the stomach: hamorrhagic |
300 |
1-0 female |
14 (killed) |
No abnormalities detected |
300 |
3-0 female |
14 (killed) |
No abnormalities detected |
300 |
3-1 female |
14 (killed) |
No abnormalities detected |
300 |
3-2 female |
14 (killed) |
No abnormalities detected |
300 |
3-3 female |
14 (killed) |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was determined to be >300 and <2000 mg/kg. Therefore, the substance should be classified as harmful if swallowed according to Regulation 1272/2008.
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