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EC number: 848-537-7 | CAS number: 1912392-88-1
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, conducted according to GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 421(reproductive/developmental toxicity screening test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetramethylammonium hydroxide
- EC Number:
- 200-882-9
- EC Name:
- Tetramethylammonium hydroxide
- Cas Number:
- 75-59-2
- Molecular formula:
- C4H12N.HO
- IUPAC Name:
- tetramethylazanium hydroxide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Doses: 0, 1, 5, 20 mg/kg bw/day
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: until copulation occurred, or two weeks.
- Proof of pregnancy: presence of sperm or a vaginal plug referred to as the day of conception (day 0 of gestation). - Duration of treatment / exposure:
- Male: 14 days before mating to the day before scheduled death through mating (total 32 days)
Female: 14 days before mating to 3 days after delivery through mating and gestation periods - Frequency of treatment:
- dialy
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 1 mg/kg bw/day
- Dose / conc.:
- 5 mg/kg bw/day
- Dose / conc.:
- 20 mg/kg bw/day
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Statistics:
- Statistical analysis : Bartlett's test, one-way analysis of variance, Dunnett's test, Kruskal-wallis test, chi-square test
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation was observed on the 4th day of administration and later in male and female rats at 5 mg/kg bw/day and higher. Salivation was considered to be due to strong alkaline property of TMAH, but not due to toxic effects of TMAH.
In the female animals at 20 mg/kg bw/day, a decrease in locomotor activity, incomplete eyelid opening or eyelid closure, and loss of hair were observed on GD 21 and thereafter. - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- One female rat at 20 mg/kg bw/day died on GD 22 and another one on GD 23 during parturition.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In the female animals and a significant decrease in body weight on days 0 and 4 after parturition (PND 0 and 4) was observed.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- A significant decrease in food consumption was observed at 20 mg/kg bw/day on gestation day (GD) 20 in female animals.
Maternal developmental toxicity
- Details on maternal toxic effects:
- Salivation was observed on the 4th day of administration and later in maternal rats at 5 mg/kg bw/day and higher. Salivation was considered to be due to strong alkaline property of TMAH, but not due to toxic effects of TMAH. A significant decrease in food consumption was observed at 20 mg/kg bw/day on gestation day (GD) 20 in female animals. In the female animals at 20 mg/kg bw/day, a decrease in locomotor activity, incomplete eyelid opening or eyelid closure, and loss of hair were observed on GD 21 and thereafter, and a significant decrease in body weight on days 0 and 4 after parturition (PND 0 and 4). One female rat at 20 mg/kg bw/day died on GD 22 and another one on GD 23 during parturition. Based on these observations, the NOAEL for parental toxicity was considered to be 5 mg/kg bw/day in rats.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food efficiency
- mortality
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No gross abnormalities were observed during macroscopic external examination of control pups or those from treated dams.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects up to highest dose tested (20 mg/kg bw/day)
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a reproductive/developmental toxicity screening test in rats [OECD TG 421], TMAH was administered by gavage at doses of 0, 1, 5 and 20 mg/kg bw/day. No effect of TMAH was observed on any reproductive or developmental parameters up to 20 mg/kg bw/day, the highest dose tested, while some toxic effects on parental animals (a decrease in food consumption, a decrease in locomotor activity) were observed at 20 mg/kg bw/day. Thus the NOAEL for parental toxicity was considered to be 5 mg/kg bw/day and the NOAEL for reproductive/developmental toxicity was considered to be 20 mg/kg bw/day in rats.
- Executive summary:
In a reproductive/developmental toxicity screening test according to OECD TG 421, Sprague-Dawley rats (10/sex/group) were orally administered TMAH (by gavage) at doses of 0, 1, 5 and 20 mg/kg bw/day.
No effect of TMAH was observed on any reproductive or developmental parameters up to 20 mg/kg bw/day, the highest dose tested, while some toxic effects on parental animals (a decrease in food consumption, a decrease in locomotor activity) were observed at 20 mg/kg bw/day. Thus the NOAEL for parental toxicity was considered to be 5 mg/kg bw/day and the NOAEL for reproductive/developmental toxicity was considered to be 20 mg/kg bw/day in rats.
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