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EC number: 201-073-3 | CAS number: 77-98-5
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 September, 2010 - 14 October, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetraethylammonium hydroxide
- EC Number:
- 201-073-3
- EC Name:
- Tetraethylammonium hydroxide
- Cas Number:
- 77-98-5
- Molecular formula:
- C8H20N.HO
- IUPAC Name:
- tetraethylammonium hydroxide
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Tetraethylammonium Hydroxide, (35% TEAH, in water)
- Description: clear liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: no data
- Weight at study initiation: males: 268 - 286 g; females: 188 - 240 g
- Housing: Individually housed in suspended wire cages
- Diet: Free access to PMI Rat Chow diet
- Water: Free access to water.
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.
A single dose of the test substance was applied to the prepared site, over a porous gauze dressing measuring 4 x 6 cm. The torso was wrapped with ppastic in a semi-occlusive manner and was secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
Residual test sbstance was removed by gently washing with distilled water. - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Dose volume: no data
Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: twice a day
Body weights: pretest, weekly and at termination
Clinical signs: 1, 2 and 4 hours and once daily for 14 days
- Necropsy of survivors performed: All animals were examined for gross pathology. - Statistics:
- None.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- dissolved
- Remarks:
- 35% aqueous solution
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 700 mg/kg bw
- Based on:
- other: pure test substance
- Mortality:
- 2 males and 1 female died.
- Clinical signs:
- other: The male and female rats were normal up to 4 hours after dosing. Shortly after the 4 hour observation, among 2 males convulsing and vocalizing were observed. The 2 males were found dead on day 1. All remaining males were normal at all other observation pe
- Gross pathology:
- Necropsy observations were normal except for the skin, which appeared to have pale and dark areas (necrotic). The dose sites appeared to have been depilated for 3 out of 10 animals. Two males were noted with redness and/or brown staining of the nose/mouth area. One female was noted with red staining of the nose/mouth area.
- Other findings:
- Skin observations of the surviving animals at 24 hours were necrotic with pale areas. Edema was absent to very slight. On days 7 and 14, skin was necrotic with flaking of the skin on 2 animals by day 14. There was no edema noted.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD 402 guideline and GLP principles, an LD50 >2000 mg/kg bw was determined for TEAH (35% aqueous solution). This is equivalent to an LD50 of >700 mg/kg bw for the pure substance.
- Executive summary:
An acute dermal toxicity test with 35% tetraethylammonium hydroxide was performed according to OECD 402 test guideline and GLP principles. Male and female rats were exposed to 2000 mg/kg bw. Two males and one female died.
Clinicals signs included convulsing, vocalizing, few feces, wetness of the anogenital area and chromorhinorrhea. Skin observations of the surviving animals at 24 hours revealed necrotic tissue with pale areas. Edema was absent to very slight. The LD50 was found to be >2000 mg/kg bw, this is equivalent to an LD50 of >700 mg/kg bw for the pure substance.
Therefore, TEAH (pure substance) is classified as category 3 for dermal toxicity according to Regulation No. 1272/2008 and should be labelled with H311: Toxic in contact with skin.
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