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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23rd July to 13th August 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Quality assurance audit and study director statement 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-sec butyl-4, 6-dinitrophenol
- IUPAC Name:
- 2-sec butyl-4, 6-dinitrophenol
- 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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Pemberley Rabbits, Cottenham, Cambridgeshire.
- Age at study initiation: approximately 9 to 10 weeks of age
- Weight at study initiation: 2.1 to 2.3 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 to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A 0.1 ml aliquot of DNBP formulation was placed into the lower everted lid of one eye of each animal.
- Duration of treatment / exposure:
- The eyelids were then gently held together for one second before releasing.
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after instillation. Observation of the eyes was aided by the use of a handheld torch.
- Number of animals or in vitro replicates:
- 2 males and 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM:
Grading and scoring of the ocular lesions were performed using the prescribed numerical scoring system as follows:
Cornea: degree of density (area most dense taken for reading):
0 - No ulceration or opacity
1 - Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 - Easily discernible translucent areas, details of iris slightly obscured
3 - Nacrous areas, no details of iris visible, size of pupil barely discernible
4 - Opaque cornea, iris not discernible through the opacity
Iris:
0 - Normal
1 - Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 - No reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae cornea and iris):
0 - Blood vessels normal
1 - Some blood vessels definitely hyperaemic (injected)
2 - Diffuse, crimson colour, individual vessels not easily discernible
3 - Diffuse, beefy red
Chemosis (lids and/or nictitating membranes):
0 - No swelling
1 - Any swelling above normal (includes nictitating membranes)
2 - Obvious swelling with partial eversion of lids
3 - Swelling with lids about half-closed
4 - Swelling with lids more than half-closed
A note was also made of any lesion not covered by this scoring system.
TOOL USED TO ASSESS SCORE:
Observation of the eyes was aided by the use of a handheld torch.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 681
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 682
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 683
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 681
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 682
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 683
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 681
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 682
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 683
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 681
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 682
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 683
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Corneal opacities developed in all three animals and persisted in one 21 days after instillation. Vascularization on the cornea was seen in two animals.
Iritis was seen in all three animals.
A diffuse crimson red colouration of the conjunctivae accompanied by considerable swelling with the eyelids about half-closed was seen in all three animals. - Other effects:
- A copious discharge was also observed in all three animals.
Any other information on results incl. tables
Instillation of DNBP formulation into the rabbit eye elicited a positive response in all three treated animals according to OECD test criteria.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of DNBP formulation into the rabbit eye elicited a positive response in all three treated animals according to OECD test criteria.
The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated. As lesions persisted to the end of the observation period at day 21, according to the dangerous substances directive, 67/548/EEC, the substance is classified as R41, Risk of serious damage to eyes. - Executive summary:
The primary eye irritation potential of the test material was evaluated when 0.1 mL was instilled into one eye of each of 3 rabbits.
Corneal opacities developed in all three animals and persisted in one 21 days after instillation. Vascularization on the cornea was seen in two animals. Iritis was seen in all three animals.
A diffuse crimson red colouration of the conjunctivae accompanied by considerable swelling with the eyelids about half-closed was seen in all three animals.
Instillation of DNBP formulation into the rabbit eye elicited a positive response in all three treated animals according to OECD test criteria.
The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated. As lesions persisted to the end of the observation period at day 21, according to the dangerous substances directive, 67/548/EEC, the substance is classified as R41, Risk of serious damage to eyes.
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