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EC number: 700-184-9 | CAS number: 1000172-11-1
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study to OECD Guidelines with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- not available. UVCB substance
- EC Number:
- 700-184-9
- Cas Number:
- 1000172-11-1
- Molecular formula:
- C28-80.H58-162
- IUPAC Name:
- not available. UVCB substance
- Test material form:
- other: colourless liquid
- Details on test material:
- Name of test material (as cited in study report): Hydrogenated oligomerisation product, including dimers and trimers, of tetradec-1-ene and alkene
- Molecular formula (if other than submission substance): C10 polyalphaolefin (trimer to hexamer oligomer mixture; C30-60.H62-122)
- Molecular weight (if other than submission substance): 552 (weight average), 528 (number average)
- Smiles notation (if other than submission substance): (CCCCCCCCCC) x 3.8 average
- Substance type: hydrogenated polyalphaolefin oligomer
- Trade name: Durasyn (R) 164 X
- Lot/batch No.: 1000172-11-1
- Physical state: clear colourless liquid
- Storage condition of test material: room temperature in a metal container with lid. Room temperature in the dark under nitrogen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Age at study initiation: Approximately 10-12 weeks old - timed-mated day 3 gestation.
- Weight at study initiation: At the start of treatment females weighed 186 to 291g.
- Fasting period before study: None
- Housing: The animals were housed in a single air-conditioned room. Environmental conditions were continuously monitored.
- Diet ad libitum
- Water ad libitum
- Acclimation period: None
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Target values of 21±2ºC.
- Humidity (%): Target values 55 ±15% respectively.
- Air changes (per hr): The rate of air exchange was at least fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): 12:12 Low intensity fluorescent light.
IN-LIFE DATES: From: 29 January 2012 To: 16 February 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): Vehicle dissolved test substance completely, was inert and formed stable solutions.
- Amount of vehicle (if gavage): 4 ml/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of test article in the formulations was determined by gas chromatography (GC) using an external standard technique. Doses tested weekly were within the range 95 to 105% of nominal value throughout treatment.
The stability and homogeneity of the test item formulations were previously determined by Harlan Laboratories Ltd., Shardlow, UK Analytical
Services (Harlan Laboratories Ltd., Project No. 41101033); See 7.8.1.
Results show the formulations to be stable for at least twenty one days.
Formulations were therefore prepared once and stored at approximately +4°C in the dark. Samples were taken of each test item formulation and were analysed for concentration of Hydrogenated oligomerisation product, including dimers and trimers,of tetradec-1-ene and alkene at Harlan Analytical Laboratory, Shardlow. The results indicate that the prepared formulations were within ± 3% of the nominal concentration. - Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant.
- Duration of treatment / exposure:
- Between GD 5 and GD 19.
- Frequency of treatment:
- Daily.
- Duration of test:
- Test terminated on GD20.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 100, 1000mg/kgbw/day
Basis:
actual ingested
measured dose by gavage
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: historical toxicology data. The oral route was selected as the most appropriate route of exposure, based on the physical properties of the test item, and the results of the study are believed to be of value in predicting the likely toxicity of the test item to man.
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS
Once daily during the gestation period. Additionally, during the dosing period observations were recorded immediately before and soon after dosing and one hour post dosing. An additional observation was also performed five hours after dosing during the normal working week. All observations were recorded.
BODYWEIGHT
Individual body weights were recorded on Day 3 (before the start of treatment) and on Days 5, 6, 7, 8, 11, 14 and 17 of gestation. Body weights were also recorded for surviving animals at terminal kill (Day 20).
FOOD CONSUMPTION
Food consumption was recorded for each surviving individual animal at Days 3, 5, 8, 11, 14, 17 and 20 of gestation.
POST MORTEM
All surviving animals were killed by carbon dioxide asphyxiation followed by cervical dislocation on Day 20 of gestation. All animals were subjected to a full external and internal examination and any macroscopic abnormalities were recorded. - Ovaries and uterine content:
- The ovaries and uteri of pregnant females were removed, examined and the following data recorded:
i) Number of corpora lutea
ii) Number, position and type of intrauterine implantation
iii) Foetal sex
iv) External foetal appearance
v) Foetal weight
vi) Placental weight
vii) Gravid uterus weight
Implantation types were divided into:
Early Death: No visible distinction between placental/decidual tissue and embryonic tissue
Late Death: Separate embryonic/foetal and placental tissue visible
Dead Foetus: A foetus that had died shortly before necropsy. These were included as late deaths for reporting purposes
All implantations and viable foetuses were numbered according to their intrauterine position - Fetal examinations:
- Foetuses from each litter were divided into two groups and examined for skeletal alterations and soft tissue alterations. Alternate foetuses were identified using an indelible marker and placed in Bouin’s fixative. Foetuses were transferred to 90% industrial methylated spirits (IMS) in distilled water and examined for visceral anomalies under a low power binocular microscope. The remaining foetuses were identified using colour coded wires and placed in 70% IMS in distilled water. The foetuses were eviscerated, processed and the skeletons stained with alizarin red. The foetuses were
examined for skeletal development and anomalies. Following examination foetuses that were examined for skeletal development were placed in 100% glycerol. - Statistics:
- The following parameters were analysed statistically, where appropriate, using the test methods outlined below:
Female body weight change, food consumption and gravid uterus weight: Bartlett’s test for homogeneity of variance and one way analysis of variance, followed by Dunnett’s multiple comparison test or, if unequal variances were observed, an alternative multiple comparison test.
All caesarean necropsy parameters and foetal parameters: Kruskal-Wallis nonparametric analysis of variance; and a subsequent pairwise analysis of control values against treated values using the Mann-Whitney ‘U’ test, where significance was seen.
Foetal evaluation parameters, including skeletal or visceral findings: Kruskal-Wallis nonparametric analysis of variance and Mann-Whitney ‘U’ test. - Indices:
- Pre- and post-implantation losses and sex ratio calculated by standard formulae.
- Historical control data:
- Not required - no observed effects to refer to.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
CLINICAL OBSERVATIONS AND MORTALITY
There were no toxicologically significant clinical observations detected in any treated females. There were no unscheduled deaths.
BODY WEIGHT
No treatment-related effects in body weight development were detected.
FOOD CONSUMPTION
No adverse effects were detected in food consumption.
POST MORTEM
No toxicologically significant macroscopic abnormalities were detected in treated females.
One female treated with 1000 mg/kg bw/day had generalised fur loss at necropsy. This was an isolated incident and is considered not to be of toxicological significance. One female treated with 300 mg/kg bw/day had a mass in the left mammary gland. As similar observations were not apparent in animals treated with 1000 mg/kg bw/day, this was considered to be an isolated finding and is considered not to be of toxicological significance.
No treatment-related effects were detected in the uterine parameters examined, in foetal viability or in growth and development.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- 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 was no adverse effect on in-utero offspring survival, as assessed by the mean numbers of early or late resorptions, live litter size and pre and post-implantation losses.
Animals treated with 300 mg/kg bw/day showed a statistically significant (p<0.01) increase in total corpora lutea when compared to control animals. In the absence of a true dose related response or any associated effects in the uterine parameters examined the intergroup difference is considered not to be of toxicological significance.
For all dose groups, there were no significant treatment-related trends in the proportion of foetuses (or litters) with evidence of visceral or skeletal anomalies. The type of visceral and skeletal anomalies were those commonly observed for this type of study.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL is considered to be 1000 mg/kg bw/day as no toxicologically significant changes were detected in the offspring parameters measured.
- Executive summary:
In a guideline (OECD414) GLP study, oral administration of "Hydrogenated oligomerisation product, including dimers and trimers, of tetradec-1-ene and alkene" to pregnant rats by oral gavage during organogenesis at dose levels of 100, 300 and 1000 mg/kg bw/day did not result in any toxicologically significant effects at any dose level. The `No Observed Adverse Effect Level' (NOAEL) was therefore, considered to be 1000 mg/kg bw/day. No toxicologically significant changes were detected in the offspring parameters measured. The `No Observed Adverse Effect Level' (NOAEL) for reproductive and developmental toxicity was therefore considered to be 1000 mg/kg bw/day.
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