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EC number: 287-484-9 | CAS number: 85536-04-5
- 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
Description of key information
Oral (OECD 422, read across): NOAEL rat, fertility≥1000 mg/kg bw/day
Oral (OECD 422, read across): NOAEL rat, systemic toxicity≥1000 mg/kg bw/day
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- refer to the analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed in the study
- Remarks on result:
- other:
- Remarks:
- Source: CAS 22393-85-7
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed in the study
- Remarks on result:
- other:
- Remarks:
- Source: CAS 22393-85-7
- Key result
- Critical effects observed:
- no
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their reproduction toxicity potential. Combined repeated dose toxicity studies with reproduction/developmental toxicity screening were performed with the two source substances Tetradecyl oleate (CAS 22393-85-7) and Docosyl docosanoate (CAS 17671-27-1) via the oral route of administration. In both studies the NOAEL for parental fertility and the developmental NOAEL was found to be ≥1000 mg/kg bw/day. Therefore, no hazard with regard to reproduction toxicity is expected for target substance Fatty acids, C16-18 (even numbered), stearyl esters (CAS 85536-04-5).
Reference
A combined repeated dose toxicity study with reproduction/developmental toxicity study with the source substance tetradecyl oleate (CAS 22393-85-7) was selected as key result for reasons of structural similarity and data reliability.
Additionally, a combined repeated dose toxicity study with reproduction/developmental toxicity study with the source substance Docosyl docosanoate (CAS 17671-27-1) is given. Rats were administered with doses up to 1000 mg/kg bw/day via gavage. Males were exposed for 28-29 days, from two weeks before mating on test day one until after mating. Females were exposed for 54 days (during 2 weeks prior to mating, during mating, during post-coitum, and during 3 days of lactation). Based on the absence of toxicologically relevant effects, both the NOAEL for parental fertility and the developmental NOAEL for offspring was ≥1000 mg/kg bw/day.
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:
- The available information comprises adequate and reliable (Klimisch score 1) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, eco-toxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There are no data on the reproduction toxicity of the target substance Fatty acids, C16-18 (even numbered), stearyl esters (CAS 85536-04-5). The assessment was therefore based on studies conducted with analogue source substances as part of a read-across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).
Toxicity to reproduction
CAS 22393-85-7
A combined repeated dose toxicity study with a reproduction/developmental toxicity screening test was performed according to OECD Guideline 422 under GLP conditions (key study, 2014). 10 rats/sex/dose were administered 0, 100, 300 and 1000 mg/kg bw/day Tetradecyl oleate (CAS 22393-85-7) once daily, via oral gavage. Males were exposed for 28-29 days, from two weeks before mating on test day one until after mating. Females were exposed for 54 days (during 2 weeks prior to mating, during mating, during post-coitum, and during 3 days of lactation).
No treatment-related parental effects were seen on viability, clinical signs, body weight (gain), food consumption, haematological parameters, clinical chemistry parameters, during observational and neurological screening, and during macroscopic and microscopic examinations. Therefore the NOAEL for parental systemic toxicity was ≥ 1000 mg/kg bw/day.
In parental animals, no effects on reproductive function (qualitative sperm staging, oestrus cycle) or performance (male and female mating and fertility indices, conception index, pre-coital interval, and number of corpora luteae and implantation sites, gestation length) were observed, compared with the control animals. The testis weight, epididymis weight, and histological examination of the testes in males as well as the weight and histological examination of the uterus and ovaries in females did not reveal any substance-related effects in the parental animals. All the pregnant females gave birth to live pups with the exception of one high dose female which had a total litter loss on day 3 post-partum. This female and two females in the control group had unilateral implantation, which is not considered to be treatment-related.
Therefore, a NOAEL for parental fertility of≥ 1000 mg/kg bw/day was derived for male and female rats.
CAS 17671-27-1
A combined repeated dose toxicity study with a reproduction/developmental toxicity screening test was performed according to OECD guideline 422 under GLP conditions (supporting study, 2014). 10 rats/ sex/dose were administered 0, 100, 300 and 1000 mg/kg bw/day Docosyl docosanoate once daily, via gavage. Males were exposed for 28-29 days, from two weeks before mating on test day one until after mating. Females were exposed for 54 days (during 2 weeks prior to mating, during mating, during post-coitum, and during 3 days of lactation).
No treatment-related parental effects were seen on viability, clinical signs, body weight (gain), food consumption, clinical chemistry parameters, during observational screening, and during macroscopic and microscopic examinations. In females, an increase in bilirubin, cholesterol and triglyceride levels was recorded at 300 and 1000 mg/kg. As this was only observed in one sex and no other hepatic changes were observed, this is not considered to be toxicologically relevant. Lower locomotor activity was recorded in males at 100 mg/kg and in females at 300 and 1000 mg/kg. As no effects were noted on other neurological parameters, this is not considered to be toxicologically relevant. Therefore, the NOAEL for parental systemic toxicity was ≥ 1000 mg/kg bw/day.
In parental animals, no effects on reproductive function (qualitative sperm staging, oestrus cycle) or performance (male and female mating and fertility indices, conception index, precoital interval, and number of corpora lutea and implantation sites, gestation length) were observed, compared with the control animals. One female from the control group had a 100% postimplantation loss, which is considered to be incidental. The testis weight, epididymis weight, and histological examination of the testes in males as well as the weight and histological examination of the uterus and ovaries in females did not reveal any substance-related effects in the parental animals. Therefore, a NOAEL for parental fertility of ≥1000 mg/kg bw/day was derived for male and female rats.
Overall conclusion for effects on fertility
Analogue read-across from source substances was applied for reproduction toxicity. No effects on reproductive parameters/organs were observed in the available screening study. The NOAEL for reproduction toxicity was at the limit dose of 1000 mg/kg bw/day. Based on the available data and following the analogue approach, absence of adverse effects on fertility can be anticipated for the target substance Fatty acids, C16-18 (even numbered), stearyl esters (CAS 85536-04-5).
Effects on developmental toxicity
Description of key information
Oral (OECD 422, read across): NOAEL rat, developmental≥ 1000 mg/kg bw/day
Effect on developmental toxicity: 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:
- The available information comprises adequate and reliable (Klimisch score 1) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, eco-toxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
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
There are no data on the developmental toxicity of the target substance Fatty acids, C16-18 (even numbered), stearyl esters (CAS 85536-04-5). The assessment was therefore based on studies conducted with analogue source substances as part of a read-across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).
CAS 22393-85-7
A combined repeated dose toxicity study with a reproduction/developmental toxicity screening test was performed according to OECD Guideline 422 under GLP conditions (key study, 2014) with Tetradecyl oleate (CAS 22393-85-7). No toxicologically relevant treatment related adverse effects were seen on viability, clinical signs, body weight, sex ratio, and gross pathology of F1 offspring. Based on these results, a developmental NOAEL of ≥ 1000 mg/kg was determined.
CAS 17671-27-1
A combined repeated dose toxicity study with a reproduction/developmental toxicity screening test was performed according to OECD guideline 422 under GLP conditions (supporting study, 2014) with Docosyl docosanoate (CAS 17671-27-1). No toxicologically relevant treatment related adverse effects were seen regarding viability, body weight, gross pathology, sex ratio, feeding, morphological examinations including behaviour observations of F1 offspring.Postural reflexes were determined on Day 1 postpartum in the pups. A significantly lower percentage of foetuses with positive response in the surface-righting reflex (righting reflex) at 1000 mg/kg bw was recorded compared to the control group. There were no treatment-related differences compared to the control animals at 100 or 300 mg/kg bw. The clinical relevance of this parameter remained unclear. Righting reflex was only assessed on Day 1 postpartum. The study report did not contain exact age matching of pups, nor considered biologically possible range of gestation length. No follow up behavioural testing at later time points during development of pups was done. Testing of righting reflex is not required following OECD GL 422.Therefore, a developmental NOAEL of ≥ 1000 mg/kg was determined based on the absence of toxicologically relevant effects.
Overall conclusion for effects on developmental toxicity
Analogue read-across from source substances was applied fordevelopmental toxicity.No toxicologically relevant effects on F1 offspring were observed in the available screening studies. The NOAEL for developmental toxicity was 1000 mg/kg bw/day.Based on the available data and following the analogue approach, absence of adverse effects on developmental toxicity can be expected for the target substance Fatty acids, C16-18 (even numbered), stearyl esters (CAS 85536-04-5).
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids, C16-18 (even numbered), stearyl esters (CAS 85536-04-5), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the analogue read-across approach the same results (no toxicity to reproduction and development) are expected for Fatty acids, C16-18 (even numbered), stearyl esters (CAS 85536-04-5). However, no final decision on classification for reproductive toxicity according to Regulation (EC) 1272/2008 can be made, as only information from a screening study is 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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