Registration Dossier
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EC number: 904-153-2 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Reference Type:
- publication
- Title:
- Newsletter
- Author:
- JETOC (Japan Chemical Industry Ecology-Toxicology & Information Center)
- Year:
- 1 995
- Bibliographic source:
- JETOC Information Sheet 18, 8-11
- Reference Type:
- review article or handbook
- Title:
- Toxicology Profile of 1,1,1-trimethylolpropane
- Author:
- BIBRA (The British Industrial Biological Research Association)
- Year:
- 1 996
- Bibliographic source:
- Bibra Toxicology International, Information Department, Carshalton , Surrey AM54DS, UK
- Reference Type:
- publication
- Title:
- Consensus Report for Trimethylolpropane.Scientific Basis for Swedish Occupational Standards XVI
- Author:
- Criteria Group for Occupational Standards (ed. Per|Lundberg)
- Year:
- 1 995
- Bibliographic source:
- Arbete Och Haelsa 19, 33-35
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- Principles of method if other than guideline:
- The study was a combined repeat dose and reproductive/developmental toxicity screening study
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Trimethylolpropane, purity 99.9%. A read across is proposed from this substance based on the structural similarity of the two substances.
Test animals
- Species:
- rat
- Strain:
- other: Slc:SD
- Details on test animals or test system and environmental conditions:
- The animals were male and female Slc:SD rats. At study initiation the males weighed 304-343 g, and the females 196-226 g. The rats were acclimatised for 5 days.
Pregnant females were housed individually. Food and water were provided ad libitum. The room temperature was 22-24°C, humidity 50-60%, with a 12 hour light/dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- The test substance was dissolved in distilled water. Dosing began 2 weeks prior to mating and continued throughout the mating period. Females were dosed throughout pregnancy and up to lactation day (LD) 4. Dosing of the males continued during this period.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Details on analytical verification were not provided.
- Details on mating procedure:
- Rats were mated 1:1 until pregnancy occurred. Day 0 of pregnancy was defined as the day sperm was present.
- Duration of treatment / exposure:
- Males were exposed for 45 days, females were exposed for 14 days before mating until LD4.
- Frequency of treatment:
- Daily
- Duration of test:
- The animals were 10 weeks old at mating. Males were sacrificed on day 46. Females and their pups were sacrificed on LD 4.
- No. of animals per sex per dose:
- 12 rats/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No further details on study design are available.
Examinations
- Ovaries and uterine content:
- The ovaries and uterine content were examined after termination, the number of corpora lutea, implantations and early resorptions were recorded.
- Fetal examinations:
- External foetal examinations were conducted.
- Statistics:
- Statistical analyses were performed but the methods were not provided.
- Indices:
- The following reproductive indices were calculated: copulation index, fertility index, gestation index, implantation index, delivery index, birth index and viability index.
- Historical control data:
- No historical control data were provided.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
There were no maternal signs of toxicity up to the highest dose tested.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no effects indicative of developmental toxicity
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect observed
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
The NOAEL for development toxicity was 800 mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- No relevant effects were seen in this study: the NOAEL for developmental toxicity was 800 mg/kg bw/d.
- Executive summary:
The developmental toxicity of TMP was investigated in a screening study (OECD 422) in rats performed at dose levels of up to 800 mg/kg bw/d. Males were exposed for 45 days, females were exposed for 14 days before mating until LD4. T he ovaries and uterine content were examined after termination, the number of corpora lutea, implantations and early resorptions were recorded. External foetal examinations were conducted. No relevant effects were seen in this study: the NOAEL for developmental toxicity was 800 mg/kg bw/d.
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