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Diss Factsheets
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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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-02-29 to 1988-03-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study OECD 406
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Magnusson & Kligman maximisation test (J. Invest. Dermatol. 52, 268-276, 1969)
- GLP compliance:
- no
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
Test material
- Reference substance name:
- Octylphenol PT
- IUPAC Name:
- Octylphenol PT
- 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): 1,1,3,3-Tetramethylbutylphenol (Octylphenol PT)
- Physical state: solid
- Analytical purity: 96%
- Impurities (identity and concentrations): ca. 1 % 1,1,3,4-Tetramethylbutylphenol; ca. 2% 1,1,2-Tetramethylpentylphenol; < 1% 0-1,1,3,3-Tetramethylbutylphenol
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: average 335.5 g (control group) and 341.2 g (test group)
- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage)
- Diet (e.g. ad libitum): Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 17 days
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- Induction (intradermal):
A: 0.1 ml Freunds Complete Adjuvants (FCA): H2O (1:1)
B: 0.1 ml 1% OP in corn oil;
C: 0.1 ml 1% OP in FCA:corn oil (1:1)
control group received the same type of injections but without substance
Challenge (patch test):
one week after injection: 50% OP on 2 x 4 cm filter paper for 48 h
two weeks after injection: 20% OP on 2 x 2 cm filter paper for 24 h
control group was challenged only once (14 days after injection)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction (intradermal):
A: 0.1 ml Freunds Complete Adjuvants (FCA): H2O (1:1)
B: 0.1 ml 1% OP in corn oil;
C: 0.1 ml 1% OP in FCA:corn oil (1:1)
control group received the same type of injections but without substance
Challenge (patch test):
one week after injection: 50% OP on 2 x 4 cm filter paper for 48 h
two weeks after injection: 20% OP on 2 x 2 cm filter paper for 24 h
control group was challenged only once (14 days after injection)
- No. of animals per dose:
- test animals: 20
control animals: 10 - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 1 (in duplicates)
- Exposure period: intracutaneous injections (0.1 cm³)
- Concentration in Freunds Complete Adjuvants (FCA):50% in H2O
- Test group: FCA w/o test substance; test substance in corn oil; test substance in FCA:corn oil (1:1)
- Control group: FRCA in water; corn oil; FCA:corn oil (1:1)
- Frequency of applications: day 0: intradermal treatment, days 7 and 14 : patch test
- Duration: 3 weeks
- Concentrations: 1% v/v, test substance was melt
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 7 & 14
- Exposure period: 48 & 24 h
- Test groups: 50% & 20 % test substance in corn oil
- Control group: day 7: corn oil; day 14: 20 % test substance in corn oil
- Site: left flanks
- Evaluation (hr after challenge): 48 and 72 hours after application - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
RESULTS OF TEST
- Sensitization reaction: All animals of the control group and of the test group showed no specific findings after 48 an 72 h after the second challenge (Score = 0).
- Clinical signs:
1. The test and control animals showed a normal body weight gain throughout the investigation.
2. After intradermal induction: All induction sites of test and control animals treated with FCA showed intense erythema, swelling and necrosis. Treatment with 1% test substance in corn oil induced distinct erythema and swelling. Corn oil showed slight erythema and swelling.
3. After patch test: All induction sites with FCA showed bloody inflammations. 24 hours after patch removal distinct erythema and swelling on the application sites and at the shoulder area (test animals). All injection sites showed incrustations (test and control animals).
Due to local effects only results of tests without FCA were considered in the evaluation of the sensitizing potential.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- 1,1,3,3-Tetramethylbutylphenol has no sensitizing potential in a guinea pig maximization test (OECD 406) after intradermal induction with 1% and challenge with 50% and 20% after 7 and 14 days.
- Executive summary:
In a dermal sensitization study with 1,1,3,3-Tetramethylbutylphenol (96%) in corn oil or FCA/corn oil, 20, female albino guinea pigs (Bor:DHPW) were tested using the method of Magnussen-Kligman.
All induction sites of test and control animals treated with FCA showed intense erythema, swelling and necrosis. Treatment with 1% test substance in corn oil induced distinct erythema and swelling. Corn oil showed slight erythema and swelling. After patch test all induction sites with FCA showed bloody inflammations. 24 hours after patch removal distinct erythema and swelling occurred on the application sites and at the shoulder area (test animals). All injection sites showed incrustations (test and control animals).
Distinct local effects are caused by the irritating properties of the substance. (1,1,3,3 -Tetramethylbutyl)phenol is not considered a dermal sensitizer based on an OECD 406 guideline study.
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