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Diss Factsheets
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EC number: 202-532-0 | CAS number: 96-76-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1990-04-30 to 1990-05-24
- 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:
- 1 990
- Report date:
- 1990
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 test was carried out before the Reach law was in force.
Test material
- Reference substance name:
- 2,4-di-tert-butylphenol
- EC Number:
- 202-532-0
- EC Name:
- 2,4-di-tert-butylphenol
- Cas Number:
- 96-76-4
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2,4-di-tert-butylphenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Purity: 99.5%
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 377 g (control group) and 368 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: not mentioned
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal: 5% v/v in corn oil;
- Concentration in Freunds Complete Adjuvants (FCA): 5%; dermal: 50% v/v in corn oil.
- Challenge schedule: day 21: removal of patches after 24 hours, evaluation after 24 and 48 hours after patch removal.
- Concentrations used for challenge: 25% v/v in corn oil.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal: 5% v/v in corn oil;
- Concentration in Freunds Complete Adjuvants (FCA): 5%; dermal: 50% v/v in corn oil.
- Challenge schedule: day 21: removal of patches after 24 hours, evaluation after 24 and 48 hours after patch removal.
- Concentrations used for challenge: 25% v/v in corn oil.
- No. of animals per dose:
- test animals: 20 (main experiment)
control animals: 10 - Details on study design:
- RANGE FINDING TESTS: was performed with 25% test substance in corn oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: intradermal: 5% v/v in corn oil;
- Concentration in Freunds Complete Adjuvants (FCA): 5%
- Test group: dermal: test substance in corn oil (2 x 4 cm patch)
- Control group: corn oil (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with sodium dodecyl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: removal of patches after 48 hours
- Concentrations: 25% v/v, test substance was melt and stored at 40 °C
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance in corn oil (2 x 2 cm patch)
- Control group: corn oil (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 25% v/v
- Evaluation (hr after challenge): 24 and 48 hours after application - Challenge controls:
- not performed
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
RESULTS OF PILOT STUDY: no dermal irritation, no more details were mentioned
RESULTS OF TEST
- Sensitization reaction: All animals of the control group and of the test substance treated animals showed after 24 and 48 hours none specific findings (Score = 0).
- Clinical signs: 1 hour after i.c. injection: all animals of test substance and control groups showed erythema (E) and oedema (O) at the injection sites, except one animal treated with Freund¿s Adjuvant (FCA) and vehicle (H2O), which showed E, O and necrosis (N) at the injection site. 24 hours after i.c. injection: all animals of the control and test substance groups showed erythema and oedema, partly also necrosis. Reactions after dermal administration: 1 hour after patch removal: all animals of control and test substance groups showed E, O of the whole application area. 24 hours after patch removal: all animals showed E and O of the whole application area as well as eschar formation of the inflamed injection sites
- Body weights: The fluctuation in body weight observed in the test animals during the test are not regarded as related to the substance because comparable changes in bodyweight occurred for the control animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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