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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 August 1984 to 25 September 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% and a purity correction performed to give the LD50 of the substance itself.
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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- QA and study director statements included in the report
- Test type:
- standard acute method
- Limit test:
- no
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:
- - Name of test material (as cited in study report): DNBP formulation.
- Commercial name; Dinoseb (DNBP) in oil 300 g/l
- Substance type: solution
- Physical state: liquid
- Analytical purity: 30 – 31.2% in oil
- Storage condition of test material: Ambient conditions
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: HC/CFY (Remote Sprague-Dawley)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Limited, Huntingdon, Cambridgeshire, England
- Age at study initiation: approximately six to eight weeks of age
- Weight at study initiation: weight range of 194 to 253 g
- Housing: Individually housed in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum - Scientific Feeds LAD 1 obtained from Special Diet Services Ltd., Witham, Essex, England
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum period of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C to 24°C
- Humidity (%): 65%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark
IN-LIFE DATES: From: To: The study was undertaken between 15 August and 25 September 1984
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal lumbar region
- % coverage: 10% of the total body surface
- Type of wrap if used: covered with gauze which was held in place with an impermeable dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): decontaminated by washing in warm (30-40°C) water and blotting dry with absorbent paper.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): used as received; volumes applied between 0.51 to 2 ml/kg bw
- Concentration (if solution): 30-31.2% w/v DNBP in oil - Duration of exposure:
- 24 hours
- Doses:
- 500, 640, 800, 1260 & 2000 mg/kg (0.51, 0.65, 0.82, 1.29 and 2 ml/kg, respectively)
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes
- Other examinations performed: Surviving animals in the main study were killed on Day 15 by carbon dioxide asphyxiation. All animals that died during the study and those killed on Day 15 were subjected to a macroscopic post mortem examination which consisted of opening the abdominal, thoracic and cranial cavities. The macroscopic appearance of abnormal organs when present was recorded. - Statistics:
- The acute median lethal dermal dose (LD50) to rats was calculated using the method of:
Finney (1971) Probit Analysis (3rd Edition) Cambridge University Press.
Separate LD50 values for males and females were estimated by undertaking probit analysis on the mortality data by fitting two parallel lines on the data (males only and females only) using the technique described by Finney (1978, Statistical Method in Biological Assay, 3rd Edition, Charles Griffin, London). A chi-squared test was carried out to check that the data did not contain any evidence for non-parallelism.
Results and discussion
- Preliminary study:
- A trial test was carried out by dosing two male and two female rats at 1000 mg/kg bodyweight. None of the treated animals died.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 217.5 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 192.6 - 257.4
- Remarks on result:
- other: Corrected for purity
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 242.7 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 203.7 - 313.2
- Remarks on result:
- other: Corrected for purity
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 198.3 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 165 - 234
- Remarks on result:
- other: Corrected for purity
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 725 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 642 - 858
- Mortality:
- Mortalities occurred among rats treated at dose levels of 640 mg/kg and above from within four and 25 hours of dosing.
- Clinical signs:
- other: Clinical signs observed among animals treated with DNBP formulation were lethargy, ptosis, pallor of the extremities, diuresis, increased salivation and increased respiratory rate. Other than animals treated at 1260 mg/kg these signs were not generally ob
- Gross pathology:
- Autopsy of animals which died during the test revealed congestion of the lungs and pallor of the liver, kidneys and spleen. Slight congestion of the subcutaneous blood vessels at the treatment site was seen among these animals.
Terminal autopsy findings were normal. - Other findings:
- No dermal reactions were observed in any animal although yellow staining of the skin precluded an accurate assessment of erythema.
Any other information on results incl. tables
The acute median lethal dermal dose and its 95% confidence limits were estimated to be:
Males and females combined: 725 (642 to 858) mg/kg
The slope of the probit line was 11.0 with a standard error of 3.4 using log transformation of dose.
When probit analysis was carried out on the mortality data by fitting two parallel lines the values were:
Males only: 809 (679 to 1044) mg/kg bodyweight
Females only: 661 (550 to 780) mg/kg bodyweight
The slope of the parallel probit lines was 12.3 with a standard error of 3.8 using log transformation of dose. The heterogeneity factor was not significant.
The chi-squared test for parallelism gave no evidence of non-parallelism.
Table 1. Mortality data for groups of rats dosed dermally with DNBP formulation - Preliminary study.
Dose (g/kg) |
Mortality ratio (No. of deaths / No. dosed) | Time of death after dosing (hours) | ||
Male | Female | Combined | ||
1 | 0/2 | 0/2 | 0/4 | - |
Table 2. Time and number of deaths of rats dosed dermally with DNBP formulation - Main study.
Sex | Dose (mg/kg) |
Number of deaths in a group of 5 | Day | ||||||||||||
1 | 2 | 3 | 15 | ||||||||||||
Hours after dosing | |||||||||||||||
½ | 1 | 2 | 3 | 4 | 5 | 6 | a | b | a | b | a | b | |||
Male | 500 | 0 | |||||||||||||
640 | 0 | ||||||||||||||
800 | 3 | 3 | |||||||||||||
1260 | 5 | 2 | 2 | 1 | |||||||||||
2000 | 5 | 5 | |||||||||||||
Female | 500 | 0 | |||||||||||||
640 | 4 | 4 | |||||||||||||
800 | 3 | 3 | |||||||||||||
1260 | 5 | 5 | |||||||||||||
200 | 5 | 5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: toxic
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the substance as tested was determined to be 725 mg/kg bw to both male and female rats which is equivalent to approximately 217.5 mg/kg bw for the active ingredient. The substance is therefore classified as toxic.
- Executive summary:
In an acute dermal toxicity study conducted in accordance with OECD method 402 and under an appropriate quality assurance system, groups of 5 male and 5 female rats, the animals were dosed dermally with a 30-31.2% w/v preparation of the substance in oil. The animals were dosed at 500, 640, 800, 1260 & 2000 mg/kg bodyweight and were observed for 14 days after an exposure period of 24 hours.
The LD50 of the substance as tested was determined to be 725 mg/kg bw to both male and female rats which is equivalent to approximately 217.5 mg/kg bw for the active ingredient. The substance is therefore classified as toxic.
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