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EC number: 269-537-8 | CAS number: 68298-05-5
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate
- EC Number:
- 269-537-8
- EC Name:
- (2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate
- Cas Number:
- 68298-05-5
- Molecular formula:
- C7H8O3S.C4H11NO
- IUPAC Name:
- (2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- 1-Butanol
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- Batch# 1776194
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were received from Charles River, Raleigh NC, on 15 Oct 2015 and 05 Nov 2015. Following an acclimation period of at least five days, three male and three healthy, non-pregnant and nulliparous female Sprague Dawley rats were assigned to treatment groups without conscious bias.
The animals were born on 19 Aug 2015 and 09 Sep 2015. The pretest body weight range was
250 - 258 grams for males and 200 - 207 grams for females. The weight variation of the animals used did not exceed ±20% of the mean body weight of the previously dosed animals within a sex.
The animals were identified by cage notation and indelible body marks, and housed in suspended wire cages; five per sex per cage prior to dosing and three per sex per cage following dosing. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle to three female rats and three male rats.
- Doses:
- Dose level of 2000 mg/kg was administered to three female rats and three male rats.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- In Vivo – Animals were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects and twice daily for mortality. Body weights were recorded immediately pretest, weekly, at death and at termination in the survivors.
Post Mortem – All animals were humanely sacrificed using CO2 and were examined for gross pathology following study termination.
Analysis of Data
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 918 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: LD50 was calculated for the registered substance based on its content in the tested product (45.9%).
- Mortality:
- Two female rats survived following a single 2000 mg/kg oral dose. One animal was found dead on Day 1.All three male rats survived following a single 2000 mg/kg oral dose.
- Clinical signs:
- other: Female Prior to death, abnormal physical signs including piloerection, lethargy, and dyspnea were observed. Among the survivors, prostration, lethargy, sagging eyelids, and piloerection were observed. Male Abnormal physical signs including piloerection, a
- Gross pathology:
- Female
The gross necropsy, of the animal that died, revealed red staining of the nose/mouth area and abnormalities of the gastrointestinal tract. No observable abnormalities were observed among the survivors.
Male
The gross necropsy revealed emaciated appearance, bloated abdomen, chromodacryorrhea, chromorhinorrhea, and abnormalities of the gastrointestinal tract.
Applicant's summary and conclusion
- Conclusions:
- The oral LD50 determined for the test item by OECD 423 method is greater than 2000 mg/kg b.w. The oral LD50 calculated for Propan-1-ol,2-amino-2-methyl-, 4-methylbenzenesulphonate was 918 mg/kg b.w..
- Executive summary:
The oral LD50 determined for the test item by OECD 423 method is greater than 2000 mg/kg b.w. The oral LD50 calculated for Propan-1-ol,2-amino-2-methyl-, 4-methylbenzenesulphonate was 918 mg/kg b.w.
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