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EC number: 202-190-2 | CAS number: 92-79-5
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.-20.02.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD guideline not specified in the report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-hydroxy-4'-methoxy-2-naphthanilide
- EC Number:
- 202-190-2
- EC Name:
- 3-hydroxy-4'-methoxy-2-naphthanilide
- Cas Number:
- 92-79-5
- Molecular formula:
- C18H15NO3
- IUPAC Name:
- 3-hydroxy-4'-methoxy-2-naphthanilide
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-strain: CBA/CaOlaHsd
- Source: Harlan Netherlands
- Age at study initiation: 8-9 weeks (beginning of treatment)
- Weight at study initiation: 18.3 g to 23.7 g
- Housing: single caging, Makrolon Type I, with wire mesh top, granulated soft wood bedding
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 0.03, 0.3, 1.0, 3.0, 10.0% (w/v)
- No. of animals per dose:
- 5 animals per treatment group, 5 animals in the control group
- Details on study design:
- Topical Application:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface
of each ear lobe (left and right) with different test item concentrations of 0.03, 0.3, 1, 3, and
10% (w/v) in dimethylsulfoxide. The application volume, 25 μl, was spread over the entire
dorsal surface (diameter approx. 8 mm) of each ear lobe once daily for three consecutive days. A further
group of mice was treated with an equivalent volume of the relevant vehicle alone (control
animals).
Administration of 3H-Methyl Thymidine:
3H-methyl thymidine (3HTdR); specific activity 2 Ci/mmol; concentration 1 mCi/ml).
Five days after the first topical application, all mice were administered with 250 μl of
81.2 μCi/ml 3HTdR (corresponds to 16.2 μCi 3HTdR per mouse) by intravenous injection
via a tail vein.
Determination of Incorporated 3HTdR:
Approximately five hours after treatment with 3HTdR all mice were euthanised by
intraperitoneal injection of Pentobarbital-Natrium.
The draining lymph nodes were rapidly excised and pooled per animal (2 nodes per animal).
After preparation of the cells, precipitation and resuspension, the level of 3HTdR incorporation was measured in a
β-scintillation counter. The β-scintillation counter expresses 3HTdR incorporation as the number of
radioactive disintegrations per minute.
Interpretation of Raw Data:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.
Observations:
In addition to the sensitising reactions the following observations and data were recorded
during the test and observation period:
- mortality / Viability once daily (week day) from experimental start to necropsy.
- body weights prior to the first application and prior to treatment with 3HTdR.
- clinical signs (local / systemic) once daily (week day). Especially the treatment sites
were observed carefully. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated.
The ANOVA (Dunnett-test) was conducted to assess whether the difference is statistically
significant between test item groups and negative control (vehicle) group. Statistical
significance was at the five per cent level (p < 0.05). However, both biological and
statistical significance were considered together.
Results and discussion
- Positive control results:
- EC3: 15.7% (w/v) (experiment performed in February 2008)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 0.03%
- Key result
- Parameter:
- SI
- Value:
- 1.95
- Test group / Remarks:
- 0.3%
- Key result
- Parameter:
- SI
- Value:
- 1.68
- Test group / Remarks:
- 1%
- Key result
- Parameter:
- SI
- Value:
- 1.75
- Test group / Remarks:
- 3%
- Key result
- Parameter:
- SI
- Value:
- 2.28
- Test group / Remarks:
- 10%
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Remarks:
- all S.I.´s are below 3
Any other information on results incl. tables
No deaths, clinical signs or abnormal body weight development were observed during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found not to be a skin sensitiser in the LLNA when tested at 0.03, 0.3, 1.0, 3.0 and 10.0% in DMSO (w/v).
An EC3 value could not be calculated, since all S.I.´s are below 3. - Executive summary:
In order to study a possible contact allergenic potential of Naphtol AS-RL, five groups each
of five female mice were treated daily with the test item at a concentrations of 0.03, 0.3, 1,
3, and 10% (w/v) in dimethylsulfoxide by topical application to the dorsum of each ear lobe
(left and right) for three consecutive days. A control group of five mice was treated with the
vehicle (dimethylsulfoxide) only. Five days after the first topical application the mice were
injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine).
Approximately five hours after intravenous injection, the mice were sacrificed, the draining
auricular lymph nodes excised and pooled per animal. Single cell suspensions of lymph
node cells were prepared from pooled lymph nodes, which were subsequently washed and
incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph
node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-
scintillation counter.
The animals did not show any clinical signs during the course of the study and no cases of
mortality were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test
concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared
with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated
concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 1.13, 1.95, 1.68, 1.75 and 2.28 were determined with
the test item at concentrations of 0.03, 0.3, 1, 3, and 10% in dimethylsulfoxide.
The EC3 value could not be calculated, since none of the tested concentrations induced
an S.I. greater than 3.
Statistical evaluation was performed by Dunnett-Test (ANOVA) (p > 0.05). At the
concentrations of 0.3, 1, 3, and 10 % of test item a statistically significant difference of
DPM per animal was determined (p = <0.001). Nevertheless, the threshold S.I. value of 3
was not reached with any of the tested concentrations.
The test item Naphtol AS-RL was found to be not a skin sensitiser under the described
conditions. The study was performed in compliance to OECD TG 429 and GLP.
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