Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / 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 acording to GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / 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
- Specific details on test material used for the study:
- TMAH (Lot No. 40914), Vehicle: water, purity: over 99.9•%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Doses: 0, 1, 5, 20 mg/kg bw/day
- 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). - Analytical verification of doses or concentrations:
- not specified
- 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:
- daily
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
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day
DETAILED CLINICAL OBSERVATIONS: Yes
- Signs recorded include: changes in salivation, locomotor activity, fur, eyelid opening or closure
BODY WEIGHT: Yes
- Time schedule for examinations: The male animals were weighed on Day 1 and 3 of dosing, and weekly thereafter. The female animals were weighed on Day 1, 3 and 7 of dosing, weekly thereafter until delivery, and PND 0 and 4. Body weights of the live pups were also recorded. - Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, clinical signs, ody weights and weight gain (PND 4). At the termination of the experiment (PND 4), all animals including pups were sacrificed and autopsied.
GROSS EXAMINATION OF DEAD PUPS:
yes, for external gross abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
At the termination of the experiment (PND 4) all surviving animal (male, female, pups) were sacrificed
GROSS NECROPSY
HISTOPATHOLOGY / ORGAN WEIGHTS - Postmortem examinations (offspring):
- SACRIFICE
At the termination of the experiment (PND 4), all F1 pups were sacrificed and autopsied.
GROSS NECROPSY
HISTOPATHOLOGY / ORGAN WEIGTHS - Statistics:
- Statistical analysis : Bartlett's test, one-way analysis of variance, Dunnett's test, Kruskal-wallis test, chi-square test
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 Day 3 in male animals and on gestation day (GD) 20 in female animals.
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
Details on results (F1)
Based on these observations, the NOAEL for reproductive/developmental toxicity was considered to be 20 mg/kg bw/day in rats.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 20 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect up to the highest dose tested (20 mg/kg bw/day)
Overall reproductive toxicity
- Reproductive 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.