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EC number: 430-320-1 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th January - 17th February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Pentaerythritol mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Cas Number:
- 141686-49-9
- IUPAC Name:
- Pentaerythritol mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Reference substance name:
- Trimethylol propane mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Cas Number:
- 141686-50-2
- IUPAC Name:
- Trimethylol propane mixed esters with 2-methyl butyric acid, n-pentanoic acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid, n-decanoic acid
- Test material form:
- liquid
- Details on test material:
- Identification: Hatcol ® 1772
Appearance/physical state: Clear colorless liquid
Purity: 100% (no solvent present)
Composition: 70% pentaerythritol esters described by CAS# 141686-49-9; 30% trimethylolpropane esters described by CAS# 141686-50-2
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ANIMAL INFORMATION
Male and female Sprague-Dawley CD (Crl: CD®BR) strain rats supplied by Charles River (UK) Ltd., Margate, Kent, UK. were used. At the start of the main study the males weighed 210 to 225 g, and the females 201 to 218 g, and were eight to twelve weeks of age. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
ANIMAL CARE AND HUSBANDRY
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 19 to 21°C and relative humidity of 50 to 67%. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- One dose of test material (5000 mg/kg)
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table 1: Individual clinical observations and mortality data in the range-finding study
Dose level (mg/kg) | Animal Number and Sex | Effects noted after dosing (hours) | Effects noted during period after dosing (hours) |
||||||
0.5 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | ||
5000 | 1 -0 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 -0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2: Individual bodyweights and weekly bodyweight changes in the main study
Dose level (mg/kg) | Animal Number and Sex | Bodyweight (g) at day | Bodyweight gain (g) during week | |||
0 | 7 | 14 | 1 | 2 | ||
5000 | 3 -0 Male | 216 | 297 | 352 | 81 | 55 |
3 -1 Male | 225 | 320 | 388 | 95 | 68 | |
3 -2 Male | 222 | 299 | 351 | 77 | 52 | |
3 -3 Male | 221 | 302 | 375 | 81 | 73 | |
3 -4 Male | 210 | 284 | 330 | 74 | 46 | |
4 -0 Female | 218 | 270 | 296 | 52 | 26 | |
4 -1 Female | 201 | 238 | 250 | 37 | 12 | |
4 -2 Female | 209 | 246 | 258 | 37 | 12 | |
4 -3 Female | 205 | 240 | 257 | 35 | 17 | |
4 -4 Female | 211 | 257 | 268 | 46 | 11 |
Table 3: Individual necropsy findings in the main study
Dose level (mg/kg) | Animal Number and Sex | Time of Death | Macroscopic Observations |
5000 | 3 -0 Male | Killed Day 14 | No abnormalities detected |
3 -1 Male | Killed Day 14 | No abnormalities detected | |
3 -2 Male | Killed Day 14 | No abnormalities detected | |
3 -3 Male | Killed Day 14 | No abnormalities detected | |
3 -4 Male | Killed Day 14 | No abnormalities detected | |
4 -0 Female | Killed Day 14 | No abnormalities detected | |
4 -1 Female | Killed Day 14 | No abnormalities detected | |
4 -2 Female | Killed Day 14 | No abnormalities detected | |
4 -3 Female | Killed Day 14 | No abnormalities detected | |
4 -4 Female | Killed Day 14 | No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat was found to be greater than 5000 mg/kg bodyweight.
- Executive summary:
Introduction
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and the US EPA Health Effects Test Guidelines OPPTS 870.1100 (draft).
Method
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single dose of undiluted test material, at a dose level of 5000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
Mortality
There were no deaths.
Clinical signs
No signs of systemic toxicity were noted during the study.
Body weight
All animals showed an expected gain in bodyweight during the study.
Gross pathology
No abnormalities were noted at necropsy.
Conclusion
The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat was found to be greater than 5000 mg/kg bodyweight.
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