Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-426-2 | CAS number: 140-66-9
- 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
- Study period:
- 1984-05-23 to 1984-06-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-(1,1,3,3-tetramethylbutyl)phenol
- EC Number:
- 205-426-2
- EC Name:
- 4-(1,1,3,3-tetramethylbutyl)phenol
- Cas Number:
- 140-66-9
- Molecular formula:
- C14H22O
- IUPAC Name:
- 4-(2,4,4-trimethylpentan-2-yl)phenol
- Details on test material:
- - Name of test material (as cited in study report): Octylphenol PT
- Physical state: solid
- Analytical purity: 96% (provided by sponsor, not part of the study report)
- Impurities (identity and concentrations): not mentioned
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: not mentioned
- Production date of the lot/batch: not mentioned
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar: Bor strain, WISW (SPF TNO)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: average weight male = 201 g; female = 150 g
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- paraffin oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
10 - 20 ml/kg bw - Doses:
- 3160, 3980, 4495 and 5010 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: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- The means of the body weights were calculated.
The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 040 mg/kg bw
- 95% CL:
- 3 640 - 4 484
- Mortality:
- 3160 mg/kg bw: one male and one female died after 48 h
3980 mg/kg bw: two males and one female died after 28-170 h
4495 mg/kg bw. two males and five females died after 48 h
5010 mg/kg bw. all animals died after 48 h - Clinical signs:
- other: The signs observed 30 minutes after administration were ruffled fur, crouched posture, slight sedation and ataxia, diarrhoea, diuresis, prone position, hypothermia, cyanosis, labored breathing, staggering, trembling and small deep-red eyes. One animal got
- Gross pathology:
- Post mortem dissection revealed hyperaemia of the gastro-intestinal tract, as well as of peritoneum and pleura and sporadic spots on kidneys, liver and lung. One animal indicated a redness mucosa of the bladder.
Dissection of surviving animals at the end of the experiment showed partially hyperaemia of the small intestine,
swelling of the gastric mucosa and fusion of liver, stomach and spleen with peritonium.
Any other information on results incl. tables
Table #: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity (#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
3160 |
1 / 5 |
1 / 5 |
2 / 10 |
48 |
5 / 5 |
5 / 5 |
10 / 10 |
3980 |
2 / 5 |
1 / 5 |
3 / 10 |
28 - 170 |
5 / 5 |
5 / 5 |
10 / 10 |
4495 |
2 / 5 |
5 / 5 |
7 / 10 |
48 |
5 / 5 |
5 / 5 |
10 / 10 |
5010 | 5 / 5 | 5 / 5 | 10 / 10 | 48 | 5 / 5 | 5 / 5 | 10 / 10 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on an LD50 (rat) of 4040 (3640-4484) mg/kg bw p-(1,1,3,3,-Tetramethylbutyl)-phenol is not classified as acute toxic
- Executive summary:
In an acute oral toxicity study, groups of fasted Wistar rats (5/sex) were given a single oral dose p-(1,1,3,3,-Tetramethylbutyl)-phenol in paraffin oil at doses of 3160, 3980, 4495 and 5010 mg/kg bw and observed for 14 days.
Oral LD50 Combined = 4040 mg/kg bw (3640 - 4484)
(1,1,3,3,-Tetramethylbutyl)-phenol is of LOW Toxicity based on the combined LD50.
The signs observed 30 minutes after administration were ruffled fur, crouched posture, slight sedation and ataxia, diarrhoea, diuresis, prone position, hypothermia, cyanosis, labored breathing, staggering, trembling and small deep-red eyes. One animal got anorexia. The treated animals showed signs of toxicity for up to 7 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
