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EC number: 430-550-0 | CAS number: 1671-49-4
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 April - 21 July 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 430-550-0
- EC Name:
- -
- Cas Number:
- 1671-49-4
- Molecular formula:
- C8H9NO4S
- IUPAC Name:
- 4-methanesulfonyl-1-methyl-2-nitrobenzene
- Details on test material:
- - Physical state: white solid
- Storage condition of test material: ambient temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 8-12 weeks
- Weight at study initiation: 266-404 g (males), 193-263 g (females)
- Fasting period before study: overnight prior to dosing
- Housing: maximum of 5 per cage, sexes separately in cages suitable for rats of this strain and weight range expected during the course of the study
- Diet: RMI ad libitum (except during overnight fast)
- Water: mains water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 30-70%
- Air changes: minimum of 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 2 June 1999 To: 21 July 1999
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- Dose levels prepared by adjusting concentration of the dosing preparations. The volume of the dose was calculated for each animal according to its weight at the time of dosing. A standard volume of 10 mL/kg bodyweight of the dosing preparation was dosed.
- Doses:
- 200, 500, 1000 or 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed twice on day 1 and once per day thereafter. Weighed prior to fasting (day -1), immediately before dosing (day 1) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: none - Statistics:
- The acute oral median lethal dose was estimated from mortality data by logistic regression using nominal dose values. Confidence limits calculated using a likelihood ratio interval (Williams DA, 1986. Interval Estimation of the Median Lethal Dose. Biometrics 42, 641-645).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 426 mg/kg bw
- Based on:
- test mat.
- Remarks:
- 2479
- 95% CL:
- 971
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 933 mg/kg bw
- Based on:
- test mat.
- Remarks:
- 1259
- 95% CL:
- 692
- Mortality:
- 200 or 500 mg/kg - no deaths; 1000 mg/kg - 1 male and 3 females killed in extremis on day 2; 2000 mg/kg - 4 males and all 5 females found dead or killed in extremis between days 1 and 3.
- Clinical signs:
- other: 200 mg/kg - signs of slight systemic toxicity (including tip-toe gait, lachrymation, salivation, subdued behaviour, upward curvature of spine and breathing irregular) with complete recovery by day 2. 500 mg/kg - signs of slight or moderate toxicity (inclu
- Gross pathology:
- No treatment-related findings at 500 mg/kg. In the other groups there was a reduction in testes and epididymes of some males, changes to the stomach/abnormal stomach contents and pallor of liver and kidneys, speckling of the thymus and non-specific staining around the nose and mouth.
Any other information on results incl. tables
Table 1: Mortality data
Dose Level |
Day Number |
Number of Deaths |
|
(mg/kg) |
|
Male |
Female |
200 |
Total at day 15 |
0/5 |
0/5 |
500 |
Total at day 15 |
0/5 |
0/5 |
1000 |
2 |
1 |
3 |
Total at day 15 |
1/5 |
3/5 |
|
2000 |
1 |
0 |
1 |
2 |
3 |
4 |
|
3 |
1 |
0 |
|
Total at day 15 |
4/5 |
5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of the test substance was estimated to be 1426 mg/kg (95% confidence limits 971-2479) to male rats and 933 mg/kg (95% confidence limits 692-1259) to female rats.
- Executive summary:
Groups of 5 male and 5 female Alpk:APfSD rats received a single oral dose of 200, 500, 1000 or 2000 mg/kg of the test substance. The animals were assessed daily for the following 14 days for any signs of systemic toxicity and their bodyweights recorded at intervals throughout the study. Animals in extremis and those surviving to the end of the study were killed and, together with those found dead, subjected to a macroscopic examination post mortem. Surviving animals showed signs of slight to moderate toxicity which were resolving towards the end of the experimental period. Findings at post mortem were restricted to males dosed with 1000 mg/kg and above and included reduced testicular and epididymal weights. The acute oral LD50of the test substance was estimated to be 1426 mg/kg (95% confidence limits 971-2479) to male rats and 933 mg/kg (95% confidence limits 692-1259) to female rats.
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