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EC number: 261-675-7 | CAS number: 59231-37-7
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- developmental toxicity
- Type of 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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Read-across to similar substance.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Full information on the read-across approach is provided in the attached justification document.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source and target substances are composed of the same chemical groups and are bonded together in functionally the same way. The source substance and target substances have low water solubility, high partition coefficient, and are in the physical form of a liquid with a neutral pH. Available toxicity information on the source and target substances indicates that they behave in substantially similar ways in the body. The potential for reproductive toxicity is therefore the same in all substances.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The substances are hydrophobic oils at room temperature, with no hydrophilic groups and poor water solubility (all < 0.1 mg/l). The only chemical group present in each substance is the ester group. The boiling points are > 160°C, typically with decomposition >300 °C. The substances are also lipophilic, all with partition coefficients >7.2. The relative densities are all closely related, all being approximately 0.85
All are UVCB substances – with only one part of each substance being from a UVCB source (the stearic acid component of the 2-ethylhexyl stearate, and the alcohol components of the target substances. All the carbon-carbon bonds are saturated, giving a constant ratio of one carbon to two hydrogens across all the substances.
Each substance also has a branched component, which is present from the ester due to the mono-constituent substance used to synthesise it. In the case of the 2-ethylhexyl stearate, this is the alcohol part of the substance. In the case of the target substances Isodecyl 3,5,5-trimethylhexanoate and Isotridecyl 3,5,5-trimethylhexanoate, both the acid part and the alcohol part are branched (although the alcohol is varied due to the UVCB alcohols used as an ingredient for both). The C12-15 Alkyl Ethylhexanoate has the same branched aliphatic chain that the 2-ethylhexyl stearate does, but it is from the acid component rather than the alcohol component.
A difference is that the variation for the 2-ethyl hexyl stearate is along the acid but only in increments of two carbons, which are all linear. The target substances show variation in the alcohol part of the ester, and this variation involves both linear and branched aliphatics – with the C12-15 Alkyl Ethylhexanoate showing additional variation here due to the number of carbons being between twelve and fifteen, whereas they are constant for Isodecyl 3,5,5-trimethylhexanoate (ten carbons) and Isotridecyl 3,5,5-trimethylhexanoate (thirteen carbons). The three target substances also all have a branched acid component which the source substance does not share.
The source substance also only has an even numbered amount of carbons in the acid component, whereas this is only shared in the C12-15 Alkyl Ethylhexanoate, with the Isodecyl 3,5,5-trimethylhexanoate and Isotridecyl 3,5,5-trimethylhexanoate having an odd numbered amount of carbons in the acid component.
The alcohol component of the 2-ethylhexyl stearate is both branched, which it shares with C12-15 Alkyl Ethylhexanoate, Isodecyl 3,5,5-trimethylhexanoate, and Isotridecyl 3,5,5-trimethylhexanoate. The alcohol component is also even numbered, which it only shares with C12-15 Alkyl Ethylhexanoate and Isodecyl 3,5,5-trimethylhexanoate, and not Isotridecyl 3,5,5-trimethylhexanoate. It should also be noted that due to the nature of the alcohol component of C12-15 Alkyl Ethylhexanoate, both even numbered and odd numbered amounts of carbons are present in the alcohol chain in the substance.
The substances have also been tested for toxicity (oral) and the conclusions were that neither the source substance nor target substances were classified for toxicity (LD50 > 2000 mg/kg bw). In addition, skin and irritation tests also concluded no classification under CLP 1278/2008.
These common phys-chem properties, and the similar results for toxicity and skin/eye irritation/corrosion, indicate that the substances will share similar bioavailability and toxicity.
3. ANALOGUE APPROACH JUSTIFICATION
Due to the similarities of the source and target substances with regards to branching, odd and even numbered alkyl and acid chains, the target substances are expected to behave in a substantially similar manner in vivo.
The target substances are therefore predicted to fail to induce effects of developmental toxicity in the OECD 414 study when conducted in the rat. By extension, the target substances are considered not to fulfil the criteria for reproductive toxicity under the Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
4. DATA MATRIX
Full information on the read-across approach is provided in the attached justification document. - Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat. (total fraction)
- Basis for effect level:
- body weight and weight gain
- mortality
- Abnormalities:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat. (total fraction)
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- external malformations
- skeletal malformations
- visceral malformations
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- no analytical purity given
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- adopted in 2001
- Deviations:
- yes
- Remarks:
- Exposure duration was only from day 6-15 of gestation instead of day 5-19; no analytical purity given
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexyl stearate
- EC Number:
- 244-754-0
- EC Name:
- 2-ethylhexyl stearate
- Cas Number:
- 22047-49-0
- Molecular formula:
- C26H52O2
- IUPAC Name:
- 2-ethylhexyl stearate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: mean approx. 197 g
- Housing: individually in Makrolon Type M3 cages
- Diet: Pelleted Altromin Maintenance Diet 1324 (Altromin GmbH, Lage, Germany), ad libitum (analytically controlled per batch)
- Water: tap water, ad libitum (once weekly controlled)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 40-56
- Air changes (per hr): 10-15 per hr
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Arachidis oil, DAB 10
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The dosing solutions were prepared daily before administration.
VEHICLE
- Amount of vehicle (if gavage): 5 mL/kg bw
All groups received a dose volume of 5 mL/kg body weight, adjusted to the body weight of day 6 post coitum. - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant, at day 0
- Proof of pregnancy: vaginal plug day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 up to day 15 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- until day 20 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 24 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Other:
group 1: 0 mg/kg bw/day
group 2: 100 mg/kg bw/day
group 3: 300 mg/kg bw/day
group 4: 1000 mg/kg bw/day
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: Post mortem examination, including gross macroscopic examination of all maternal organs, with emphasis on the uterus, uterine contents, position of fetuses in the uterus and number of corpora lutea, was performed and the data recorded.
BODY WEIGHT: Yes, mean body weight changes
- Time schedule for examinations: days 0, 6, 16 and 20 of gestation - 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
- Other: dead/living foetuses
Number and distribution of intrauterine implantations were classified as live or death fetuses, late intrauterine deaths (resorptions), early intrauterine (resorption sites). The fetuses were removed from the uterus. Intrauterine deaths were classified on the basis of the presence (late) or absence (early) of fetal or decidual tissue in addition to placental tissue. - Fetal examinations:
- - External examinations: Yes: half per litter
- Soft tissue examinations: Yes: half per litter: malformations oh hydrocephalus, variations of brain, adrenal gland, renal pelvis, ureter
- Skeletal examinations: Yes: half per litter: malformations of hydrops, retardations of skull bones, hyoid, sternebrae, pelvis, 13th rib
- Head examinations: Yes: half per litter
The live fetuses were sexed, weighed individually including placentae, examined for gross external abnormalities and allocated to one of the following procedures:
1) The Wilson technique was applied to half of the foetuses to evaluate potential visceral changes (Wilson and Warkany, 1965).
2) The remaining fetuses were placed non individually in a solution of potassium hydroxide for clearing and were stained with alizarin red according to Dawson, 1926. All abnormalities were recorded. - Statistics:
- The following statistical methods were used:
- If the variables could be assumed to follow a normal distribution, the Dunnett-Test, based on a pooled variance, was applied for the comparison between the treated groups and the control group.
- The Steel-Test was applied when the data could not be assumed to follow a normal distrubution.
- Fisher's Exact test for 2x2 tables was applied if the variables could be dichotomized without loss of information (Bonferroni-Holm-corrected). - Historical control data:
- Findings both on the individual foetus and an the litter basis did not differ from the historical control obtained in six developmental toxicity studies on the same species.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The dams tolerated the applied dose levels of up to 1000 mg/kg bw/day without lethality and clinical signs of systemic toxicity.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Maternal body weight gain was not affected by the treatment. Body weight profiles of the pregnant females were essentially similar in all groups. Mean corrected body weight gain of the treatment groups compared favourably with the control values.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No organ weight changes were noted in the dams of the groups 1 - 4.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No macroscopic changes were noted in the dams of the groups 1 - 4.
- Other effects:
- no effects observed
- Description (incidence and severity):
- Gross macroscopic examination of the maternal organs including ovaries and uterus revealed no alterations.
Maternal developmental toxicity
- Pre- and post-implantation loss:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No compound-related differences were noted between the mean reproduction data of the test groups in comparison to the control group. In the group 2 and 4 the post-implantation loss and total embryonic deaths were significantly decreased. These findings were considered to be incidental because of the high control values. Furthermore the number of total fetuses was increased in the group 2 and 4, which is also incidental because there was no dose-relationship.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat. (total fraction)
- Basis for effect level:
- body weight and weight gain
- changes in number of pregnant
- clinical signs
- gross pathology
- mortality
- organ weights and organ / body weight ratios
- other: maternal toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- The weights of live fetuses exibited no significant differences on a litter and individual basis e.g. mean weight between the control group and the treatment groups.
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- Apart from dose group 1000 mg/kg bw/day (one dead foetus) all females had viable foetuses. Pre- and post implantation loss and mean numbers of resorption were unaffected by treatment. All parameters were comparable with the animals of the control group. Skeletal and visceral investigations detected no treatment-related malformations.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- The sex ratio of the fetuses was not effected by the treatment with the test substance.
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No macroscopical findings were noted at external examination of fetuses which were considered to be an effect of the treatment with the test article. In the group 1 was noted a beginning hydrops and in the group 4 one fetus with paleness and one dead fetus.
- Other effects:
- no effects observed
- Description (incidence and severity):
- The weights of placentae and the whole uterus showed no significant differences between the control group and the treatment groups.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat. (total fraction)
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- changes in litter size and weights
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat. (total fraction)
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- changes in litter size and weights
- external malformations
- skeletal malformations
- visceral malformations
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Mean body weights and standard deviation
mg/kg | Mean body weight/standard deviation | |||
0 | 100 | 300 | 1000 | |
Day 0 pc | 196±13.7 | 198.6±17.4 | 197.7±18.1 | 195.9±20.4 |
Day 6 pc | 235.5±19.1 | 236.4±17.6 | 237.7±18.3 | 232.6±20.4 |
Day 16 pc | 308.3±29.8 | 309.1±25.0 | 313.5±22.4 | 309.7±27.7 |
Day 20 pc | 362.6±40.2 | 361.7±28.1 | 370.7±29.6 | 364.7±30.5 |
Summary of the reproduction data: average per group ± standard deviation
Parameter | Control | 100 mg/kg | 300 mg/kg | 1000 mg/kg |
No. of females | 24 | 24 | 24 | 24 |
Pregnant females | 22 | 22 | 23 | 23 |
Total pups | 268 | 290 | 288 | 292 |
Corpora lutea | 15.8±2.2 | 16.4±2.1 | 15.9±1.9 | 16.1±2.4 |
Implantation sites | 13.8±2.7 | 13.6±1.8 | 13.6±2.8 | 13.5±1.9 |
Pre-implantation loss in % of corpora lutea | 15.5 | 16.7 | 14.8 | 15.8 |
Post-implantation loss | 8.8 | 3.3* | 7.7 | 2.0** |
• early resporptions | 7.5 | 0.3* | 7.7 | 1.3 |
• late resorptions | 1.4 | 0 | 0.6 | 0.3 |
• dead foetuses | 0 | 0 | 0 | 0.3 |
in % of implantation sites | ||||
Living foetuses | 12.2±3.0 | 13.2±1.4 | 12.5±3.4 | 13.3±1.9 |
Sex ratio | 0.474 | 0.479 | 0.497 | 0.544 |
Foetal weight | ||||
• male | 4.3±0.7 | 4.1±0.5 | 4.5±0.9 | 4.3±0.9 |
• female | 4.1±0.6 | 3.8±0.4 | 4.2±0.9 | 4.1±0.8 |
• runts (male and female1) | 1.0±0.0 | 1.0±0.0 | 0.0±0.0 | 1.7±1.2 |
Placental weight | 0.6±0.0 | 0.6±0.1 | 0.6±0.1 | 0.6±0.1 |
1Runts are small living foetuses exhibiting a body weight less than 75% of the mean litter weight.
*Signicantly different from control at P E0.05.
**Signicantly different from control at P E0.01.
Visceral examination - foetal incidence (f) / litter (l)
Historical data (total) n=6 studies | Historical data (A. oil) n=4 studies | 2-Ethylhexyl stearate, dose level (mg/kg/day) | ||||||||||
0 | 100 | 300 | 100 | |||||||||
f | l | f | l | f | l | f | l | |||||
No. of foetuses examined | 858 | 142 | 595 | 97 | 127 | 22 | 138 | 22 | 138 | 23 | 140 | 22 |
Malformations | ||||||||||||
Hydrocephalus internus | 3 | 3 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Variations | ||||||||||||
Brain lateral sinus dilation | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
Adrenal gland cyst | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Hydronephrosis (renal pelvis dilated) | 163 | 69 | 119 | 52 | 28 | 15 | 34 | 13 | 26 | 15 | 24 | 13 |
Ureter dilated | 44 | 27 | 30 | 18 | 9 | 6 | 12 | 8 | 5 | 5 | 10 | 5 |
Ureter waved | 32 | 22 | 32 | 22 | 5 | 4 | 3 | 3 | 6 | 4 | 8 | 6 |
Historical vehicle data (total): 2 studies treated with water and four studies treated with arachidis oil.
Historical vehicle data (A. oil): Treated with arachidis oil.
Skeletal examination - foetal incidence (f) / litter incidence (l)
Historical data (total) n=6 studies | Historical data (A. oil) n=4 studies | 2-Ethylhexyl stearate, dose level (mg/kg/day) | ||||||||||
0 | 100 | 300 | 100 | |||||||||
f | l | f | l | f | l | f | l | |||||
No. of foetuses examined | 935 | 142 | 650 | 97 | 141 | 22 | 152 | 22 | 150 | 23 | 152 | 22 |
Malformations | ||||||||||||
Hydrops | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Retardations | ||||||||||||
Skull bones: incompl. oss. | 37 | 27 | 22 | 14 | 3 | 3 | 4 | 4 | 2 | 1 | 3 | 3 |
Hyoid: incompl. oss. | 16 | 12 | 10 | 8 | 2 | 2 | 5 | 4 | 4 | 3 | 2 | 2 |
Hyoid: non-ossified | 36 | 22 | 24 | 12 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 |
Single sternebrae: incompl. oss. | 343 | 118 | 242 | 82 | 52 | 18 | 61 | 22 | 44 | 17 | 38 | 15 |
Two sternebrae: incompl. oss. | 103 | 59 | 84 | 45 | 11 | 8 | 34** | 15 | 24 | 11 | 29* | 13 |
Two sternebrae: non-oss. | 46 | 24 | 24 | 16 | 4 | 2 | 4 | 4 | 7 | 5 | 21** | 10 |
Several sternebrae: incompl. oss. | 9 | 8 | 8 | 7 | 2 | 2 | 0 | 0 | 1 | 1 | 1 | 1 |
Several sternebrae: non-oss. | 17 | 5 | 3 | 3 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
Pelvis: incompl. oss. | 6 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
13th rib: incompl. oss./absent ul | 9 | 8 | 7 | 6 | 0 | 0 | 2 | 2 | 3 | 3 | 2 | 1 |
Variations | ||||||||||||
Ribs additional: rudim./short ul | 15 | 13 | 14 | 12 | 3 | 2 | 3 | 3 | 8 | 6 | 10 | 9 |
Ribs additional: rudim./short bl | 19 | 15 | 19 | 15 | 7 | 6 | 2 | 2 | 5 | 4 | 7 | 5 |
Vertebrae: dumbbell shaped | 244 | 97 | 202 | 74 | 53 | 19 | 62 | 20 | 52 | 17 | 57 | 20 |
Vertebrae: bipartited | 21 | 20 | 18 | 17 | 6 | 6 | 4 | 4 | 4 | 4 | 3 | 3 |
Fisher's exact test (two-sided) signicant at level greater than P = 0.05 * or 0.01 ** (performed at foetal incidences only) (Bonferroni-Holm corrected).
Applicant's summary and conclusion
- Conclusions:
- The developmental NOAEL of the test material was considered to be 1000 mg/kg bw/day under the conditions of the test.
- Executive summary:
2-Ethylhexyl stearate was investigated in an embryo-/foetotoxicity and teratogenicity study on rats according to OECD guidelines for the testing of chemicals (No. 414). Dose levels of 0 (arachidis oil), 100, 300 and 1000 mg/kg body weight/day were administered by gavage. Dams tolerated the applied dose levels without any toxic effects. Pre- and post-implantation loss and mean numbers of resorptions were unaffected by treatment. All parameters were comparable with the animals of the control group. Skeletal and visceral investigations revealed no treatment-related malformations. For embryo-/foetotoxicity, teratogenicity and maternal toxicity a NOAEL of 1000 mg/kg was deduced.
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.