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EC number: 201-063-9 | CAS number: 77-85-0
- 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

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- OECD Combined Repeat Dose and Reproductive/Developmental Toxicity Screening Test.
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Slc:SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 304-343 g; femalws: 196-226 g
- Housing: pregnant females should be caged individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 50-60
- Photoperiod 12 hrs dark / 12 hrs light
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- dosing of both sexes should begin 2 weeks prior to matingm continued through mating period
males: dosing continued up to the day when females are killed
females: dosing continued throughout pregnancy and up to day 4 of lactation - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- data not given
- Duration of treatment / exposure:
- Male: 45 days
Female: from 14 days before mating to day 3 of lactation - Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0, 12.5, 50, 200, 800 mg/kg/day
Basis: - No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: no
- Positive control:
- no
- Observations and examinations performed and frequency:
- at least once per day:
--behavioural changes, signs of difficult or prolonged parturition, mortality and all signs of toxicity
cage side observations:
changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system fucnction
--food consumption, males and females should be weighed
--duration of gestation, examination of the litter as soon as possible, number and sex of pups, stillbirth, live birth, pup weight, and the presence of gross anomalies
--clinical examinations: hematologym clinical chemistry, urinalysis
--pathology: gross necropsy, histopathology - Sacrifice and pathology:
- males day 43
females day 4 of lactation - Other examinations:
- as required by the guideline
- Statistics:
- non parametric analysis
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- for reproductive toxicity see section 7.8.1
BODY WEIGHT AND WEIGHT GAIN
800 mg/kg bw/day: males and females: lowered during premating period when compared to controls
ORGAN WEIGHTS
males:
800 mg/kg bw/day, significant: absolute mean liver weight: 13.92 g versus 11.55 g of controls
800 mg/kg bw/day, significant. relative mean liver weight: 3.647 g% versus 2.926 g% of controls
females
800 mg/kg bw/day, non-significant: absolute mean liver weight: 11.54 g versus 10.54 g of controls
800 mg/kg bw/day, non-significant. relative mean liver weight: 4.237g% versus 4.014g% of controls
GROSS PATHOLOGY / HISTOPATHOLOGY: NON-NEOPLASTIC
liver:
Necropsy revealed hypertrophy of th liver in 3 male rats receiving 800 mg/kg.
Histopathological examintion revealed no definite morphological lesions.
kidneys:
Slight basophilic alteration of the renal tubular epithelial cells was observed in
1 female receiving 50 mg/kg, in 2 females receiving 200 mg/kg and in 5 females receiving 800 mg/kg.
These changes were not unequivocally attributable to the test substance administration, because of their limited distribution and limited degree,
and because similar lesions were observed in male rats of all groups including the controls.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Executive summary:
Trimethylolpropane was studied for oral toxicity in an OECD TG 422 (combined repeat dose and reproductive/ developmental toxicity screening test) at doses of 0. 12.5, 50, 200, and 800 mg/kg bw/day given by gavage. For repeat dose toxicity the NOAEL was achieved at 200 mg/kg bw/day based on lowered body weight when compared to the controls, and significantly increased absolute and relative liver weights in males and elevated liver weights in females receiving 800 mg/kg bw/day with histopathological changes which could not be unequivocally attributed to treatment (MHLW 1994).
Reference
There were no deaths or any abnormal clinical signs
attributable to the treatment in male und female rats of any
group throughout the dosing period. The body weights of both
males and females given 800 mg/kg were lower than those of
the control group during the premating period. Food
consumption revealed no differences between the control and
treated groups. There were no observed effects of the test
substance on hematological findings of the treated males.
Blood chemical examination revealed no changes indicating
any specific organ dysfunctions. Absolute and relative liver
weights were elevated significantly in male rats receiving
800 mg/kg and increased but not significantly, in female
rats receiving 800 mg/kg. Necropsy revealed hypertrophy of
the liver in 3 male rats receiving 800 mg/kg.
Histopathological examintion revealed no definite
morphological lesions. Slight basophilic alteration of the
renal tubular epithelial cells was observed in 1 female
receiving 50 mg/kg, in 2 females receiving 200 mg/kg and in
5 females receiving 800 mg/kg. These changes were not
unequivocally attributable to the test substance
administration, because of their limited distribution and
limited degree, and because similar lesions were observed in
male rats of all groups including the controls.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Guideline study rated Klimisch 1 (relaiable without restriction).
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Justification for classification or non-classification
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