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EC number: 201-861-7 | CAS number: 88-85-7
- 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:
- 9th October to 7th November 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in accordance with recognised guideline. Although no data is available on the study's GLP compliance equivalent quality assurance methods were in place at the testing laboratory. The substance is present in an oil formulation at ca.30%. No positive control used.
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 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- The test group consisted of 20 animals.
- GLP compliance:
- not specified
- Remarks:
- Quality assurance audit and study director statement are included in the report
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The testing using the guinea pig test protocol was completed in 1984. The Local Lymph Node Assay (OECD 429) was not formally adopted by the OECD until 22 July 2010.
Test material
- Reference substance name:
- 2-sec-butyl-4, 6-dinitrophenol
- IUPAC Name:
- 2-sec-butyl-4, 6-dinitrophenol
- Reference substance name:
- Dinoseb
- EC Number:
- 201-861-7
- EC Name:
- Dinoseb
- Cas Number:
- 88-85-7
- Molecular formula:
- C10H12N2O5
- IUPAC Name:
- dinoseb
- Details on test material:
- Dinoseb (DNBP) in oil 300 g/l.
30-31.2% w/w DNBP.
DNBP formulation, a brown liquid, was received on 11 July 1984 and was stored at ambient temperature.
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: D. Hall, Newchurch, Staffordshire, England.
- Weight at study initiation: 360-430g
- Housing: the guinea-pigs were housed in suspended cages with wire mesh floors
- Diet/water (e.g. ad libitum): free access to tap water and a Vitamin C-enriched Guinea-Pig Diet F.D.1 (Special Diets Services Limited).
Hay was given once weekly.
- Acclimation period: the guinea-pigs selected for the study were all acclimated to the laboratory environment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21°C
- Humidity (%): 30-70%
- Air changes (per hr): Air exchange was maintained at approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by means of a time switch to give 12 hours of artificial light in each 24 hour period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction:
0.05% v/v in water for injection & 5% v/v in water for topical patch application (48 hrs exposure)
Challenge:
5% v/v in water for patch application (24 hrs exposure)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction:
0.05% v/v in water for injection & 5% v/v in water for topical patch application (48 hrs exposure)
Challenge:
5% v/v in water for patch application (24 hrs exposure)
- No. of animals per dose:
- 20 females for test dose group & 10 females for Freund's control group
- Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of aqueous dilutions of DNBP formulation was investigated to identify
(a) irritant test substance concentrations suitable for the induction phase of the main study and
(b) non-irritant concentrations by the topical route of administration for the challenge phase.
Using these criteria, the following concentrations of DNBP formulation would have been selected:
Induction: Intradermal injection: 0.05% v/v in water for injection.
Topical application: DNBP formulation, as supplied.
Challenge: 10% and 5% v/v in distilled water.
However, when these concentrations were utilised for the main study, all the test animals were found dead the day after the induction topical application of DNBP formulation, as supplied.
The study was therefore repeated using lower concentrations of DNBP formulation to avoid problems of toxicity and allow completion of the test.
The following concentrations of DNBP formulation were selected for the repeat test:
Induction:
Intradermal injection: 0.05% v/v in water for injection.
Topical application: 5% v/v in distilled water.
Challenge: 5% v/v in distilled water.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections:
A 4 x 6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made simultaneously into this area as shown in Figure 1.
Injectables were prepared as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for injection.
2. DNBP formulation, 0.05% v/v in water for injection.
3. DNBP formulation, 0.05% v/v in a 50 : 50 mixture of Freund's complete adjuvant and water for injection.
Topical application:
One week after the injections, the same 4 x 6 cm interscapular area was clipped and shaved free of hair.
A 2 x 4 cm patch of Whatman No. 3 paper was saturated with DNBP formulation, 5% v/v in distilled water. The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape (5 cm width "Blenderm"). This in turn was firmly secured by elastic adhesive bandage ("Elastoplast" 5 cm width) wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.
B. CHALLENGE EXPOSURE
The test and control animals were challenged topically two weeks after the induction period using DNBP formulation, 5% v/v in distilled water.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig. A 2 x 2 cm patch of Whatman No. 3 paper was saturated with approximately 0.2 ml of DNBP formulation, 5% v/v in distilled water and applied on the flank.
The patch was sealed to the flank for 24 hours under a strip of "Blenderm" covered by "Elastoplast" wound round the trunk and secured with "Sleek". - Challenge controls:
- During the induction period, the control animals were treated similarly to the test animals, with the exception that the test compound was omitted from the intradermal injections and topical application.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% v/v test material in water
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Freund's treated control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% v/v test material in water
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Freund's treated control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% v/v test material in water
- No. with + reactions:
- 20
- Total no. in group:
- 20
Any other information on results incl. tables
The numerical scores awarded to the dermal reactions elicited by the challenge application are shown in Table 1.
The dermal reactions observed in all twenty test animals were more severe than the maximum reaction seen in animals of the control group.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- In this test, performed in twenty albino guinea-pigs, DNBP formulation produced evidence of delayed contact hypersensitivity in all twenty animals.
- Executive summary:
The potential of the test material, as a ~30% w/v formulation in Mineral Oil, to produce delayed contact hypersensitivity in guinea pigs was evaluated using a Guinea pig maximisation test.
Following primary challenge using the test material, as a 5% v/v formulation in distilled water, all 20 treated animals showed positive responses, compared to 1 of 10 in the negative control group.
DNBP formulation produced evidence of delayed contact hypersensitivity in all twenty animals.
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