Registration Dossier
Registration Dossier
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EC number: 500-382-3 | CAS number: 157707-73-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: combined repeated dose toxicity with reproduction/developmental toxicity screening test
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 12 June 2012 to 01 October 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to relevant testing guidelines. A Klimisch score of 2 is assigned, as analytical verification of test concentrations was not possible due to low recoveries.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- analytical verification of test concentrations was not possible due to low recoveries.
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Details on species / strain selection:
- The animals were healthy male and female Crl:WI(Han) rats, obtained from Charles River (UK) Ltd., Margate, UK.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were healthy male and female Crl:WI(Han) rats, obtained from Charles River (UK) Ltd., Margate, UK. The range-finding animals were approximately 10-12 weeks of ages and weighed 293.3 to 361.1 g (males) and 189.9 to 206.4 g (females) at the start of dosing. The main study animals were approximately 10-12 weeks of age and weighed 293.5 to 348.0 g (males) and 175.7 to 219.5 g (females) at the start of dosing.The animals were housed in a single, exclusive room, air-conditioned to provide 15 to 20 air changes/hour and maintained at a temperature of 20 to 24°C and a relative humidity of 45 to 65%. Fluorescent lighting was controlled automatically to give a cycle of 12 hours light and 12 hours darkness. The animals were housed in groups of three during the range-finding phase. Main study animals were housed in groups of up to four (pre-pairing and post pairing), one female with one male (pairing) and the females were housed individually once mated. In addition, relevant animals were housed individually for approximately 24 hours prior to FOB assessment.SQC Rat and Mouse Breeder Diet No 3, Expanded, (Special Diets Services Ltd, Witham) and mains water was provided ad libitum.All animals were given an inspection for ill health on arrival, and acclimatised for 15 days.
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Formulations were prepared daily as a suspension in corn oil, and administered by gavage. Dose volumes were 5 mL/kg; individual dose volumes were based on individual body weights. Formulations were stored at room temperature in a sealed container, and were stirred continuously before and throughout dosing.
- Details on mating procedure:
- One male was paired with one female of the same treatment group for up to 10 days. One control female did not show signs of pairing after 10 days and was re-paired with a proven male of the same treatment group. Mating was confirmed by the presence of sperm in a vaginal smear or retained vagnal plug. The day of confirmation of mating was designated as Day 0 of gestation.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- On Days 1 and 8 of dosing in the range-finding study, two aliquots were taken at random from the control/vehicle formulations and three aliquots were taken from the top and bottom of the test material formulation. Samples were stored at <-10°C pending possible analysis. On Days 1, 22 and 42 of the main study, two aliquots were taken at random from the control/vehicle formulations and three aliquots were taken from the top and bottom of the test material formulation. Samples were stored at <-10°C and dispatched to Covance Laboratories Inc., Madison, Wisconsin for analysis.
- Duration of treatment / exposure:
- Range-finding: 14 daysMain study: Males were dosed daily for 2 weeks prior to pairing, during the pairing period and a further 2 weeks before necropsy; a total of 6 weeks treatment prior to necropsy. Females were dosed once daily for 2 weeks prior to pairing, during the pairing period and until Day 4 post-partum inclusive (7 weeks prior to necropsy). The females were allowed to litter and rear their offspring to Day 4 post-partum. Dosing was deferred or omitted if the dam was in or near parturition.
- Frequency of treatment:
- Once daily.
- Details on study schedule:
- Animals were administered the test material for 2 weeks prior to mating. They were allowed up to 10 days for mating. All parental females were allowed to litter and rear offspring to Day 4 post-partum. The day pups were first observed was designated Day 0 post-partum. The date of parturition was recorded and the duration of gestation was calculated.
- Remarks:
- Doses / Concentrations:0, 100, 300, 1000 mg/kg bw/dBasis:other: nominal, range-finding study
- Remarks:
- Doses / Concentrations:0, 100, 300, 1000 mg/kg bw/dBasis:other: nominal, main study
- No. of animals per sex per dose:
- Range-finding: 3/sex/doseMain study: 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Animals were assigned to treatment groups on arrival using a total randomisation procedure. Dose levels for the range-finding study were based on the results of the acute oral toxicity study in female rats, in which there were no deaths or clinical signs of toxicity following a single oral dose of 2000 mg/kg bw. During the range-finding study, daily administration was generally well-tolerated with no remarkable clinical signs at any dose level. Mean body weight gain and food consumption were reduced at 300 and 1000 mg/kg bw/d. There were no remarkable findings at necropsy and no adverse effects on haematology or clinical chemistry. Based on these findings, the same dose levels were considered suitable for the main phase.
- Positive control:
- Not required.
- Parental animals: Observations and examinations:
- Observations were made of mortality and clinical signs throughout the study. Body weight and food consumption were recorded and functional observation battery, urinalysis, haematology and clinical chemistry analyses were performed. These investigations are presented in Section 7.5.1.
- Oestrous cyclicity (parental animals):
- Not determined.
- Sperm parameters (parental animals):
- Qualitative testis staging was performed.
- Litter observations:
- The following data were recorded for each litter: number of pups born (live and dead), daily live litter size and sex (reported on Days 1 and 4), daily clinical observations, individual pup weights on Day 1 and 4 post-partum. In addition, daily records of mortality and changes in litter size were maintained.
- Postmortem examinations (parental animals):
- Gross necropsy and histopathology were performed on adult animals, these investigations are presented in Section 7.5.1. The number of implantation sites were recorded for each female.
- Postmortem examinations (offspring):
- Gross necropsy was performed at study termination, and where possible, pups found dead or moribund were given a gross necropsy.
- Statistics:
- Gestation, mating, fertility and fecundity indices were analysed using the Cochran-Armitage test for dose-response and Fisher’s exact test for pairwise comparisons. The tests were interpreted with one-sided risk for decreased incidence with increasing dose. A significant trend (P<0.05) was only reported where none of the pairwise comparisons was significant. The number of implantation sites, number of pups born, percentage of male pups Day 1, pup weights, post implantation survival indices, live birth indices and viability 1 indices were analysed using non-parametric methods. The non-parametric methods employed were the Kruskal-Wallis ANOVA, the Terpstra-Jonckheere test for a dose related trend and the Wilcoxon rank sum test for pairwise comparisons. Where the Kruskal-Wallis ANOVA was not significant, the pairwise comparisons were not reported in order to protect the Type I error.
- Reproductive indices:
- The following indices were used to evaluate reproductive function: Mating index (no. females with determined copulations/no. oestrus cycles required for their insemination x 100); Female fecundity index (no. pregnant females/no. females mated x 100);Male fecundity index (no. males siring one or more pregnancies/no. males with one or more confirmed matings x 100);Female fertility index (no. pregnant females/no. females paired x 100);Male fertility index (no. males siring one or more pregnancies/no. males paired x 100)Median pre-coital time (time (day) by which half the females in the group had shown evidence of mating)% pre-implantation loss (no. corpora lutea - no. implantations/no. corpora lutea x 100);% post-implantation loss (no. implantations - no. live embryos/no. implantations x 100);% male foetuses (no. male foetuses/no. foetuses of determined sex x 100);Gestation index (no. females with live pups/no. pregnant females x 100);% post implantation survival index (no. pups born/no. implantation sites x 100);% live birth index (no. pups alive Day 1/no. pups born x 100).
- Offspring viability indices:
- Viability index 1 (no. pups alive Day 4/no. pups alive Day 1 x 100).
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs related to adverse taste of test material
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reductions in 1000 mg/kg bw/d males and females
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reductions in 1000 mg/kg bw/d males and females
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- mesenteric lymph node; 1000 mg/kg bw/d males and females
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed at the highest dose level
- Remarks on result:
- other: No adverse effects observed at the highest dose level
- Remarks:
- No adverse effects observed at the highest dose level
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- Not appliacble
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- body weight and weight gain
- food consumption and compound intake
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Critical effects observed:
- not specified
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Critical effects observed:
- not specified
- Key result
- Reproductive effects observed:
- not specified
- Conclusions:
- There were no effects of treatment on reproductive function or pup viability, therefore the NOAEL is considered to be 1000 mg/kg bw/d.
- Executive summary:
A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was conducted in male and female Crl:WI(Han) rats, according to OECD Test Guideline 422. The test material, TOFA_DimerFA_TETA_PAA, was administered orally by gavage. A range-finding study was conducted with groups of 3 rats/sex. The test material was administered daily by gavage for 14 days at dose levels on 0, 100, 300 and 1000 mg/kg bw/d. Based on the findings, dose levels of 100, 300 and 1000 mg/kg bw/d were selected for the main study.
In the main study, groups of 10 male rats were dosed once daily for two weeks prior to pairing, during the pairing period and a further two weeks before necropsy. Males were treated for a minimum of 6 weeks prior to necropsy. Groups of 10 female rats were dosed for two weeks prior to pairing, during pairing and until Day 4 post-partum, inclusive at total of approximately 7 weeks. The females were allowed to litter and rear their offspring to Day 4 post-partum.
There was no effect of test article administration on mating, fertility or fecundity indices; the majority of animals mated within one oestrus cycle. There was no adverse effect of treatment with TOFA_DimerFA_TETA_PAA on gestational length, number of implantation sites or pups born, pup survival or body weight gain. Pup necropsy data were unremarkable. The no-observed-adverse-effect-level (NOAEL) for reproductive and developmental toxicity was considered to be 1000 mg/kg bw/d in males and females.
Reference
Table 1. Group mean litter data
| Treatment Group | |||
0 mg/kg bw/d | 100 mg/kg bw/d | 300 mg/kg bw/d | 1000 mg/kg bw/d | |
Number females with live pups at Day 4 post-partum | 10 | 10 | 10 | 9 |
Mean duration gestation (days) | 22.4 | 22.6 | 22.5 | 22.4 |
Mean number implantation sites | 12.8 | 11.5 | 12.0 | 10.6 |
Mean number pups born | 12.3 | 10.2* | 11.4 | 9.2* |
Mean number pups alive Day 1 | 12.3 | 9.9 | 11.4 | 9.2 |
Mean % male pups Day 1 | 50.6 | 50.7 | 44.2 | 47.2 |
Mean number of pups alive Day 4 | 12.0 | 9.9 | 11.2 | 9.2 |
Post-implantation survival index % | 96.2 | 89.0 | 94.4 | 84.9 |
Live birth index % | 100 | 97.5 | 100.0 | 100.0 |
Viability index % | 97.0 | 100.0 | 98.3 | 100.0 |
* p<0.05
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Reliable screening study providing multiple endpoints.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No studies are available on the reproductive toxicity of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine. Read-across from the substance to a repeated dose toxicity study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing in accordance with EU Directive 86/609/EEC.
The effects of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine on fertility have been investigated in a combined repeated dose/reproductive screening toxicity study conducted according to OECD Test Guideline 422 (Perks, 2013). In the study groups of male and female Crl:WI(Han) rats (10 animals/group) were administered with the test substance orally by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day. Dose levels were selected based on the results of a 14-day range finding study. Male rats were dosed once daily for two weeks prior to pairing, during the pairing period and a further two weeks before necropsy. Males were treated for a minimum of 6 weeks prior to necropsy. Female rats were dosed for two weeks prior to pairing, during pairing and until Day 4 post-partum, inclusive at total of approximately 7 weeks. The females were allowed to litter and rear their offspring to Day 4 post-partum.
There were no treatment related deaths during the study. No treatment-related clinical signs, changes in bodyweight gains, histopathological changes or functional changes were observed in the study. The No-Observed-Adverse-Effect-Level (NOAEL) for the general or systemic toxicity in male and female rats was considered to be 1000 mg/kg bw/day (i.e. the highest dose tested).
No developmental effects, effects on reproductive parameters or treatment-related signs of systemic toxicity were observed in the study. No treatment-related effects were observed on mating, fertility or fecundity indices; the majority of animals mated within one oestrous cycle. No treatment-related adverse effects were observed on gestational length, the number of implantation sites or pups born, pup survival or body weight gain. Pup necropsy data were unremarkable. Based on this study, The No-Observed-Adverse-Effect-Level (NOAEL) for the effects of the substance on fertility in male and in female rats and for developmental toxicity was considered to be 1000 mg/kg bw/day (i.e. the highest dose tested).
Based on read-across to the findings of this study, Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine is not predicted to be a reproductive toxicant.
Read-across to the findings from a proposed 90-day repeated dose oral toxicity study and a pre-natal developmental toxicity study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine will provide a further characterisation of the reproductive hazard potential of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine.
Short description of key information:
Based on existing datasets and structural ad chemical considerations, read-across from Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine to an available study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. In a combined repeated dose and reproduction/developmental toxicity screening test conducted in the rat according to OECD Test Guideline 422, no effects on reproductive paramaters were observed at doses upto 1000 mg/kg bw/day (i.e. the highest dose tested). The reproductive toxicity of the substance will be characterised further based on read-across to a proposed 90-day oral repeated dose toxicity study (OECD Test Guideline 408) and a prenatal developmental toxicity study (OECD 414) conducted using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine.
Justification for selection of Effect on fertility via oral route:
Based on existing datasets and structural and chemical considerations, read-across from Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine to an available study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. No evidence of an effect on reproductive parameters was seen in a combined repeated dose and reproductive/developmental screening study (OECD 422) in rats after repeated oral doses upto 1000 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
Read-across to the findings of a proposed pre-natal developmental toxicity study (OECD Test Guideline 414) using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is considered appropriate for the characterisation of the developmental toxicity hazard potential of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- subject to ECHA approval
- Justification for type of information:
- A pre-natal developmental toxicity study in the rat (OECD Test Guideline 414) is proposed on Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine and used as read-across to characterise the repeated dose toxicity of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not applicable
- Species:
- other: not applicable
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No studies on the developmental toxicity of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine are available. Based on existing datasets and structural and chemical considerations, read-across from the substance to studies using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing in accordance with EU Directive 86/609/EEC.
No effects on developmental parameters were observed in a combined repeated dose and reproductive/developmental toxicity study conducted using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine following oral doses up to 1000 mg/kg bw/day (Perks, 2013). Based on this study, the NOAEL for developmental toxicity was considered to be 1000 mg/kg bw/day (i.e. the highest dose tested)
Testing is proposed for a pre-natal developmental toxicity study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine (OECD Test Guideline 414). Read-across to the findings of this study is considered appropriate for the characterisation of the developmental toxicity of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
Justification for classification or non-classification
No classification is proposed: relevant data are not available.
Additional information
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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