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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17th to 26th July 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%.
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Quality assurance audit and study director statements included in the report
Test material
- Reference substance name:
- Dinoseb
- EC Number:
- 201-861-7
- EC Name:
- Dinoseb
- Cas Number:
- 88-85-7
- Molecular formula:
- C10H12N2O5
- IUPAC Name:
- dinoseb
- Reference substance name:
- 2-secbutyl-4, 6-dinitrophenol
- IUPAC Name:
- 2-secbutyl-4, 6-dinitrophenol
- Details on test material:
- Dinoseb (DNBP) in oil 300 g/l.
30-31.2% w/w DNBP.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Morton Commercial Rabbits, Stansted, Essex
- Age at study initiation: approximately 9 to 11 weeks of age
- Weight at study initiation: 2.1 to 2.5 kg
- Housing: the rabbits were individually housed in metal cages with perforated floors
- Diet/water (e.g. ad libitum): free access to tap water and SDS Standard Rabbit Diet
- Acclimation period: the rabbits selected for the study were all acclimated to the laboratory environment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): Air exchange was maintained at approximately 19 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 (0700-1900 hours) in each 24 hour period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml of 30-31.2% w/w DNBP dosed as received
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4. Additional observations were made on Days 5 through 10.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0.5 ml aliquot of DNBP formulation was applied under a 2.5 cm square gauze pad to one intact skin site on each animal.
- Type of wrap if used: each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period. The animals were not restrained during the exposure period and were returned to their cages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using distilled water to remove any residual test substance.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
Erythema and eschar formation:
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well-defined by definite raising)
3 - Moderate oedema (raised approximately 1 millimetre)
4 - Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 615
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 616
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 617
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 615
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 616
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 617
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Well-defined erythema with very slight oedema was observed in all three animals on Day 2. These reactions gradually ameliorated and by Days 9 and 10 the skins were normal.
Assessment of erythema on Day 1 was precluded, due to staining of the skin by the test substance.
There were no other lesions.
Any other information on results incl. tables
A single occluded application of DNBP formulation to intact rabbit skin for four hours elicited well-defined dermal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A single occluded application of DNBP formulation to intact rabbit skin for four hours elicited well-defined dermal irritation.
The mean values of the scores for erythema and oedema formation at 24, 48 and 72 hours were calculated as 1.9 and 1 respectively and therefore the substance does not need to be classified as irritating according to the dangerous substances directive, 67/548/EEC. - Executive summary:
The primary dermal irritation potential of the test material was evaluated in rabbits under 4-hour semi-occluded conditions.
A single occluded application of DNBP formulation to intact rabbit skin for four hours elicited well-defined dermal irritation.
The mean values of the scores for erythema and oedema formation at 24, 48 and 72 hours were calculated as 1.9 and 1 respectively and therefore the substance does not need to be classified as irritating according to the dangerous substances directive, 67/548/EEC.
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