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EC number: 285-547-5 | CAS number: 85116-93-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions View details on test substance given, no analysis of the test compound
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- View details on test substance given, no analysis of the test compound
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): Trimethylolpropane caprylate caprate
- Substance type: Polyol
- Physical state: colourless liquid
- Analytical purity: No Data
- Lot/batch No.: BL 2027
- Expiration date of the lot/batch: No Data
- Storage condition of test material: No Data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: Mean of the maternal body weight: 226 g (Vehicle), 225 g (200 mg/kg/day), 227 g (600 mg/kg/day), 226 g (2000 mg/kg/day)
- Fasting period before study: No
- Housing: Virgin Rats were cohabitated with singly-housed male rats, one male per female rat for a maximum of 5 days and returned to individual housing in stainless steel wire-bottomed cages after mating.
- Diet (e.g. ad libitum): Ad libitum access to Certified Rodent Diet No. 5002 (PMI Feeds Inc. St.Louis, MO)
- Water (e.g. ad libitum): Ad libitum access to water passaged through a reverse osmosis membrane with chlorine added as a bacteriostat.
- Acclimation period: Yes, period not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- corn oil
- Details on exposure:
- TEST SITE
- Area of exposure: The back of the animals from the shoulders to the hip joints and extended ventrolaterally from the dorsal midline on each side (5x7 cm)
- % coverage: approx. 10% of the body surface
- Type of wrap if used: occlusive, gauze pad secured with Vetrap or Micropore tape
- Time intervals for shavings or clipplings: during acclimatization period
REMOVAL OF TEST SUBSTANCE
- Washing (if done): exposed area was wiped with a dermal wipe pad dampened with aqueous 1% solution of soap and then patted dry with a second clean pad
- Time after start of exposure: 6 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg
- Concentration (if solution):0, 200, 600, and 2000 mg/kg/day
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not given, (corn oil obtained from Best Food Division, Englewood Cliffs, NJ)
- Amount(s) applied (volume or weight with unit): 2 ml/kg
- Concentration (if solution): up to 100% /vehicle control)
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes, Elizabethan collar - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: maximum 5 days
- Further matings after two unsuccessful attempts: Not applicable
- Verification of same strain and source of both sexes: No Data
- Proof of pregnancy: Both, vaginal plug and/or sperm in vaginal smear were referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Treatment on Gestation Days (GD) 6 - 15
- Frequency of treatment:
- Daily
- Duration of test:
- Termination of the study by CO2 inhalation on GD 20.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg/d
Basis:
nominal conc.
(Vehicle control)
- Remarks:
- Doses / Concentrations:
200 mg/kg/d
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
600 mg/kg/d
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
2000 mg/kg/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose dependent occurrence of skin irritation. Higher levels than 2000 mg/kg/d might be expected to produce marked irritation thereby comprising the ability to interpret developmental results.
- Rationale for animal assignment (if not random): Computer-generated randomization by weight (Barlett´s test for homogeneity) such that each group were not statistically different (5% significance level) from each other.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals were checked for mortality twice daily during the treatment period and daily thereafter.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Animals were checked for signs of reaction to treatment and/or symptoms of illness once daily before treatment, approx. 60 min after treatment during the dosing period. The dosing site was examined daily prior to substance application for signs of skin irritation according to Draize.
BODY WEIGHT: Yes
- Time schedule for examinations: Recorded on GD 0 and daily during the treatment period
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: The uterus, uterine contents, position of the fetuses in the uterus and number of corpora lutea. Number and distribution of intrauterine implantations were classified as live or death fetuses, late intrauterine deaths (resorptions) and early intrauterine resorption sites. Live fetuses were sexed and further examined (see below). - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter (the heads of the animals used for soft tissue examinations) - Statistics:
- Clinical observations and other proportion data were analyzed using the Variance Test for Homogeneity of the Binominal Distribution. Quantitative continuous data were analyzed using Barlett´s Test for Homogeneity of Variance and the Analysis of Variance when Barlett´s Test was not significant (p>0.05). If the Analysis of Variance was significant (p>0.05), Dunnett´s Test was used to identify the statistical significance of the individual groups. If the Analysis of Variance was not appropriate, the Kruskal-Wallis Test was used when >75% ties were present. In case of significance (p>0.05), Dunn´s Method of Multiple Comparisons was used for identification of statistical significance of the individual groups.
- Historical control data:
- No details.
One dam having a litter consisting of seven early resorptions was pointed out as single non-dosage dependent event and to be within the ranges observed historically at the test facility.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
The two highest dose levels caused some local irritation at the site of application, but no decreases in maternal weight gain or feed consumption. Three dead animals in the control group and one dead animal in the high dosage group occurring within 6 h after first application were not considered to be treatment related and were replaced. One dam having a litter consisting of seven early resorptions was pointed out as single non-dosage dependent event and to be within the ranges observed historically at the test facility.
Necropsy findings were limited to skin flaking and scabbing first identified in life and observations related to wearing the Elizabethan collar (local alopecia, chromorhinorrhea, and neck lesions).
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no differences from control in any of the developmental parameters measured, including embryo/fetal viability, fetal weight, malformations, or variations.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Skin reaction observations
|
0 mg/kg/d |
200 mg/kg/d |
600 mg/kg/d |
2000 mg/kg/d |
Maximum possible incidencesa |
375/25 |
375/25 |
375/25 |
375/25 |
Erythema |
||||
Total |
0/0 |
2/1 |
22/4 |
91/13b |
Grade 1 |
0/0 |
2/1 |
10/4 |
81/13b |
Grade 2 |
0/0 |
0/0 |
4/1 |
10/4b |
Flaking |
||||
Total |
11/3 |
15/2 |
55/6 |
170/17 b |
Grade 1 |
11/3 |
9/2 |
27/5 |
61/14 b |
Grade 2 |
0/0 |
6/1 |
19/4 |
71/14b |
Grade 3 |
0/0 |
0/0 |
9/1 |
38/7 b |
Edema |
||||
Total |
0/0 |
0/0 |
23/4 |
83/11b |
Grade 1 |
0/0 |
0/0 |
18/4 |
59/11b |
Grade 2 |
0/0 |
0/0 |
5/1 |
24/6b |
Scab |
0/0 |
0/0 |
6/2 |
19/4 |
a: Maximum incidence : Days x rats from first treatment on GD 6 through sacrifice on GD 20 divided by the number of rats examined per group on GD 6-20
b: Significantly different from vehicle control group value (p≤0.01)
Maternal reproductive, litter, and fetal alteration observations: Caesarian-Section results on GD 20
|
0 mg/kg/d |
200 mg/kg/d |
600 mg/kg/d |
2000 mg/kg/d |
Rats pregnant and sectioned on day 20 of gestation (n) |
25 |
23 |
22b |
24 |
Corpora lutea/dam |
16.4 |
16.6 |
16.9 |
16.5 |
Implantation sites/litter |
15.0 |
15.4 |
14.9 |
14.2 |
Litter size |
||||
Live fetuses/litter |
14.6 |
14.6 |
14.0 |
13.3 |
Live fetuses (n) |
364 |
335 |
308 |
320 |
Dead fetuses (n) |
0 |
0 |
0 |
0 |
Resorptions |
0.4 |
0.9 |
0.9 |
0.9 |
Early (n) |
10 |
20 |
19 |
21 |
Late (n) |
1 |
0 |
0 |
0 |
Dams with any resorptions n(%) |
9 (36) |
11 (48) |
15 (68) |
11 (46) |
% resorbed/litter |
2.9 |
5.4 |
5.8 |
5.0 |
% male/litter |
51.3 |
50.8 |
48.1 |
47.7 |
Live fetal body weight (g/litter) |
3.68 |
3.62 |
3.69 |
3.75 |
Male |
3.77 |
3.68 |
3.82 |
3.85 |
Female |
3.58 |
3.56 |
3.58 |
3.65 |
Fetuses evaluated (n) |
364 |
335 |
308 |
320 |
Litters with any alterations observed n(%) |
10 (40) |
8 (35) |
14 (64) |
7 (25) |
Fetuses with any alterations observed n(%) |
13 (3.5) |
10 (3.0) |
20 (6.5) |
9 (2.0) |
% fetuses/litter with any alterations observed |
3.5 |
2.9 |
6.8c |
2.7 |
a: Mean-values unless otherwise indicated
b: Excludes values for dam 16854, which had a litter consisting of seven resorbed conceptuses
c: Significantly different from vehicle control group value (p≤0.05)
Fetal evaluations
|
0 mg/kg/d |
200 mg/kg/d |
600 mg/kg/d |
2000 mg/kg/d |
Litters evaluated |
25 |
23 |
22b |
24 |
Fetuses evaluated |
364 |
335 |
308 |
320 |
Live |
364 |
335 |
308 |
320 |
Fetal gross external alterations |
364 |
335 |
308 |
320 |
Tail: kinked |
||||
Litter incidence, n (%) |
0(0) |
1 (4.3) |
0(0) |
0(0) |
Fetal incidence, n (%) |
0(0) |
1(0.3) |
0(0) |
0(0) |
Body: hematoma |
||||
Litter incidence, n (%) |
1(4.0) |
0(0) |
0(0) |
0(0) |
Fetal incidence, n (%) |
1 (0.3) |
0(0) |
0(0) |
0(0) |
Fetal soft tissue alterations, evaluations |
174 |
162 |
149 |
155 |
Vessels: umbilical artery descended to the left of urinary bladder |
||||
Litter incidence, n (%) |
2(8.0) |
3(13.0) |
2(9.1) |
2(8.3) |
Fetal incidence, n (%) |
2(1.1) |
3(1.8) |
3(2.0) |
2(1.3) |
Vessels: apparent additional umbilical artery descended left of the bladder |
||||
Litter incidence, n (%) |
0(0) |
0(0) |
1(4.5) |
0(0) |
Fetal incidence, n (%) |
0(0) |
0(0) |
1(0.7) |
0(0) |
Fetal skeletal alterations, evaluations |
190 |
173 |
159 |
165 |
Cervical vertebrae: cervical rib present at 7thcervical vertebrae |
||||
Litter incidence, n (%) |
2(8.0) |
1(4.3) |
1(4.8) |
0(0) |
Fetal incidence, n (%) |
2(1.0) |
2(1.2) |
1(1.2) |
0(0) |
Thoracic vertebrae: centrum, bifid |
||||
Litter incidence, n (%) |
1(4.0) |
1(4.3) |
5(22.7) |
0(0) |
Fetal incidence, n (%) |
1(0.5) |
1(0.6) |
5(3.1)a |
0(0) |
Lumbar vertebrae: centrum, bifid |
||||
Litter incidence, n (%) |
0(0) |
1(4.3) |
0(0) |
0(0) |
Fetal incidence, n (%) |
0(0) |
1(0.6) |
0(0) |
0(0) |
Ribs: wavy |
||||
Litter incidence, n (%) |
0(0) |
0(0) |
2(9.1) |
1(4.2) |
Fetal incidence, n (%) |
0(0) |
0(0) |
2(1.2) |
1(0.5 |
Sternal centra: 1st, not ossified |
||||
Litter incidence, n (%) |
1(4.0) |
0(0) |
0(0) |
2(8.3) |
Fetal incidence, n (%) |
1(0.5) |
0(0) |
0(0) |
2(1.3) |
Sternal centra: 1st, incompletely ossified |
||||
Litter incidence, n (%) |
3(12.0) |
3(13.0) |
2(5.1) |
1(4.2) |
Fetal incidence, n (%) |
4(2.1) |
4(2.3) |
2(1.2) |
1(0.6) |
Pelvis: pubis, incompletely ossified |
||||
Litter incidence, n (%) |
3(12.0) |
0(0) |
4(18.2) |
3(12.5) |
Fetal incidence, n (%) |
3(1.6) |
0(0) |
5(3.1) |
3(1.8) |
Pelvis: ischium, incompletely ossified |
||||
Litter incidence, n (%) |
0(0) |
0(0) |
2(9.1) |
0(0) |
Fetal incidence, n (%) |
0(0) |
0(0) |
2(1.2) |
0(0) |
a: Significantly different from vehicle control group (p≤0.01)
There were no differences from control in any of the developmental parameters measured, including embryo/fetal viability, fetal weight, malformations, or variations. The test substance did not cause any developmental toxicity in the Sprague-Dawley rat at dermal dosages up to 2,000 mg/kg/day.
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.
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.
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