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EC number: 256-367-4 | CAS number: 49553-76-6
- 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
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Clinical chemistry analysis and haematological examination only performed in males. (only Japanese translation available)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Reference Type:
- secondary source
- Title:
- TRIPROPYLENE GLYCOL CAS N°: 24800-440 SIDS Initial Assessment Report for SIAM 2 (Paris, 4-6 July 1994)
- Author:
- OECD
- Year:
- 1 994
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- clinical chemistry analysis and haematological examination only performed in males
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- [(methylethylene)bis(oxy)]dipropanol
- EC Number:
- 246-466-0
- EC Name:
- [(methylethylene)bis(oxy)]dipropanol
- Cas Number:
- 24800-44-0
- IUPAC Name:
- 1,1'-[propane-1,2-diylbis(oxy)]dipropan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Tripropylene glycol
- Physical state: liquid
- Analytical purity: > 98%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD (SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: (P) 8 weeks; (F1) 8 weeks
- Weight at study initiation: (P) Males: 343 - 397 g; Females: 208 - 242 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 0.16% (8 mg/kg bw/day), 0.8% (40 mg/kg bw/day), 4% (200 mg/kg bw/day) and 20% (1000 mg/kg bw/day)
- Amount of vehicle (if gavage): 5 mL/kg bw - Duration of treatment / exposure:
- (P) Males: two weeks prior to mating, 2 weeks during mating and 2 weeks after the completion of mating period (49 days)
(P) Females: two weeks prior to mating, 2 weeks during mating, during pregnancy and until Day 3 post-partum (54 days) - Frequency of treatment:
- daily, 7 days/week
- Details on study schedule:
- ?
Doses / concentrations
- Remarks:
- Doses / Concentrations:
8, 40, 200 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: body weights of males were determined on Days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, 39, 43, 46 and 50 of the study. In females, body weights were determined on Days 1, 4, 8 and 11 during the pre-mating period, on Day 15 during mating, on Days 0, 7, 14 and 21 of pregnancy and on Days 0 and 4 of lactation period.
FOOD CONSUMPTION:
- Food consumption for each animal determined: Yes
OTHER:
- HAEMATOLOGY:
Red blood cell count (RBC), haemoglobin, haematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), platelet count, reticulocytes (RET), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, white blood cell count (WBC), differential leukocyte count (lymphocytes, neutrophils, eosinophils, basophils and monocytes)
- CLINICAL CHEMISTRY:
glutamate-oxaloacetate transaminase (GOT), glutamate-pyruvate transaminase (GPT), gamma- glutamyl transferase (GGT), total protein (TP), protein fractions of albumin and globulins, albumin-to-globulin ration (A/G), total bilirubin (T-BIL), blood urea nitrogen (BUN), creatinine, glucose, sodium, potassium, chloride, calcium, inorganic phosphorus - Oestrous cyclicity (parental animals):
- The number of times in estrous was determined 7 days before administration of the test substance and 14 days during administration.
- Sperm parameters (parental animals):
- Parameters examined in P male parental generation:
testis weight, epididymis weight - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals on Day 50 of the study
- Maternal animals: All surviving animals on Day 4 of lactation
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The kidneys, heart, liver, spleen, thymus, ovary, brain, adrenal, testis and epididymis were prepared for microscopic examination. In males, kidneys, thymus, liver, testes and epididymides were weighed. In females, organ weights of thymus, liver, kidneys and ovaries were determined. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed on Day 4 of lactation.
- These animals were subjected to postmortem examinations (macroscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - Statistics:
- Means and standard deviations of examined parameters were calculated. Statistical analysis was performed between treated and control groups and statistical significance was indicated at p < 0.05 and p < 0.01.
- Reproductive indices:
- Copulation index (%) = (number of pairs with successful copulation/number of pairs) x 100
Fertility index (%) = (number of pregnant animals/number of pairs with successful copulation) x 100
Gestation index (%) = (number of dams with live offspring/number of pregnant dams) x 100
Sex ratio = number of male offspring/number of live offspring
Birth index (%) = (number of live offspring at birth/number of implantation scars) x 100 - Offspring viability indices:
- Viability index (%) = (number of live offspring on Day 4/number of live offspring at birth) x 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day (m): increased salivation
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
In the clinical observation, increased salivation was observed in males treated with 1000 mg/kg bw/day.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Body weights and food consumption were not affected by treatment with the test substance at any dose level and were comparable to those of controls.
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
No effects on the number of times in estrous during administration of the test substance was observed in female animals compared to control.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No treatment-related effects on mating and fertility were noted in male and female animals at any dose level compared to controls.
ORGAN WEIGHTS (PARENTAL ANIMALS) (see Table 1 under "Any other information on results incl. tables")
At 1000 mg/kg bw/day, males showed significantly higher absolute and relative liver weights and increased relative kidney weights. At the same dose level, females showed higher relative liver weight.
GROSS PATHOLOGY (PARENTAL ANIMALS)
At necropsy, no treatment-related effects were observed in male and female animals. Incidental findings included pyelectasia in the right kidney of 1/12 males treated with 200 mg/kg bw/day of the test substance, whereas necropsy in females revealed spleen and stomach adhesion as well as pale colour and rough surface in 1/12 females of the control group.
HISTOPATHOLOGY (PARENTAL ANIMALS)
Histopathology did not reveal any treatment-related effects in the organs examined. Incidental findings in males of the control group included one case of slight granuloma in the heart and one case of slight nephropathy in kidney. In one female of the control group, mild adhesion to the pancreas and brown pigmentation of the spleen was observed.
OTHER FINDINGS (PARENTAL ANIMALS)
No effects on parameters of clinical chemistry and haematology were observed in treated males compared to controls.
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOEL
- Remarks:
- systemic
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical signs: increased salivation (m); organ weights: increased absolute and relative liver weights and relative kidney weights (m), increased relative liver weights (f)
- Dose descriptor:
- NOEL
- Remarks:
- systemic
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
No effects on viability were observed in offspring of the treated animals compared to those controls.
BODY WEIGHT (OFFSPRING)
No effects on the body weights were noted in offspring of treated animals compared to those of controls.
GROSS PATHOLOGY (OFFSPRING)
External examination of pups revealed no increase in appearance of abnormal pups.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1. Body and organ weights of male and female animals at sacrifice
Parameters |
Control |
8 mg/kg bw/day |
40 mg/kg bw/day |
200 mg/kg bw/day |
1000 mg/kg bw/day |
Body weight |
|
|
|
|
|
Males |
333.1 ± 15.2 |
324.7 ± 21.1 |
329.6 ± 18.2 |
333.7 ± 18.8 |
340.7 ± 19.6 |
Females |
469.6 ± 17.6 |
466.9 ± 25.7 |
471.2 ± 29.6 |
477.8 ± 26.9 |
464.1 ± 29.5 |
Liver (males) |
|
||||
Absolute (g) |
11.60 ± 0.83 |
11.48 ± 0.94 |
11.59 ± 0.97 |
12.54 ± 0.85 |
14.96 ± 1.26** |
Relative (%) |
2.47 ± 0.14 |
2.46 ± 0.14 |
2.46 ± 0.15 |
2.63 ± 0.11 |
3.23 ± 0.28** |
Liver (females) |
|
||||
Absolute (g) |
14.29 ± 1.14 |
13.42 ± 1.18 |
14.37 ± 1.16 |
14.92 ± 1.39 |
15.94 ± 1.59 |
Relative (%) |
4.29 ± 0.29 |
4.13 ± 0.15 |
4.36 ± 0.24 |
4.47 ± 0.33 |
4.67 ± 0.27* |
Kidney (males) |
|
||||
Absolute (g) |
3.11 ± 0.24 |
3.04 ± 0.25 |
3.03 ± 0.29 |
3.07 ± 0.17 |
3.33 ± 0.22 |
Relative (%) |
0.66 ± 0.05 |
0.65 ± 0.05 |
0.64 ± 0.05 |
0.65 ± 0.03 |
0.72 ± 0.04* |
Significantly different from control (*p < 0.05, **p < 0.01)
Applicant's summary and conclusion
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.
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