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EC number: 246-014-2 | CAS number: 24085-08-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 January - 25 February 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Done by OECD and GLP standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Remarks:
- OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17); and are in accordance with, and implement, the requirements of Directives 87/18/EEC (as amended by Directive 1999/11/EC) and 88/320/EEC (as amended by Directive 1999/12/EC).
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- EC Number:
- 246-014-2
- EC Name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- Cas Number:
- 24085-08-3
- Molecular formula:
- C20H25NO3.HCl
- IUPAC Name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Pale orange powder stored at room temperature in the dark over Silica Gel
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaBkl)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: B & K Universal Ltd, Hull, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 23 g
- Housing: individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by International Product Supplies Limited, Wellingborough, Northants, UK. ad libitum.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity: 30 to 70%
- Air changes (per hr): 15 approx
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06.00 to 18.00) and twelve hours darkness
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: Dimethyl formamide
Challenge
- Route:
- intradermal
- Vehicle:
- other: Dimethyl formamide
- No. of animals per dose:
- 4
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0.5%, 5% and 50% w/v in dimethyl formamide
- No. of animals per dose:
- Groups of four mice were treated with the test material at concentrations of 0.5%, 5% or 50% w/v in dimethyl formamide
- Details on study design:
- Preliminary Screening Test:
As no toxicological information was available regarding the systemic toxicity/irritancy potential of the test material a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µl of the test material, at a concentration of 50% w/v in dimethyl formamide, to the dorsal surface of each ear for three consecutive days (Days 0, 1, 2). The mouse was observed daily for 5 days. Any signs of toxicity or signs of ill health during this period were recorded. The bodyweight was recorded on Day 0 (prior to dosing) and on Day 5.
Test Material Administration:
Groups of four mice were treated with the test material at concentrations of 0.5%, 5% or 50% w/v in dimethyl formamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 0, 1, 2). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 0, 1, 2). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
Five days following the first topical application of the test material (Day 5) all mice were injected via the tail vein with 250 µl of phosphate buffered saline containing 3H-methyl thymidine (3HTdR: 80 µCi/ml, specific activity 2.0 Ci/mmol, Amersham Pharmacia Biotech UK Ltd) giving a total of 20 µCi to each mouse. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde, was considered to be a sensitiser under the conditions of the test with test control ration obtained for 25% v/v HCA at 8.4
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 0.5 % resulted in a stimulation index (SI) of 0.96 which is a negative result. Concentration of test material in the vehicle at 5 % resulted in a stimulation index (SI) of 1.54 which is a negative result. Concentration of test material in the vehicle at 50 % resulted in a stimulation index (SI) of 5.44 which is a positive result. .
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 0.5 % resulted in a mean disintegration of 10375.52 dpm which is a negative result.Concentration of test material in the vehicle at 5 % resulted in a mean disintegration of 16666.81 dpm which is a negative result. Concentration of test material in the vehicle at 50 % resulted in a mean disintegration of 58856.52 dpm which is a positive result.
Any other information on results incl. tables
A stimulation index of greater than 3 was recorded for the highest concentration of the test material (50% w/v).
A stimulation index of less than 3 was recorded for the two lower concentrations of the test material (5 and 50% w/v).
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study. |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
- Executive summary:
The test material was classified as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC.
The symbol "Xi", indication of danger 'irritant' and the risk phrase R43 "May Cause Sensitisation by Skin Contact" are therefore required.
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