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EC number: 277-288-1 | CAS number: 73138-39-3
- 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)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Developmental toxicity/teratogenicity and maternal toxicity (read-across, OECD 414) NOAEL rat: ≥1000 mg/kg bw/day
Link to relevant study records
- Endpoint:
- 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 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:
- rat
- Effect level:
- >= 900 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse toxic effects
- Remarks on result:
- other: Source: CAS 91031-31-1
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- rat
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse toxic effects
- Remarks on result:
- other: Source: CAS 853947-59-8
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- rat
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse toxic effects
- Remarks on result:
- other:
- Remarks:
- Source: CAS 853947-59-8
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental 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 repeated dose toxicity potential. In a developmental toxicity oral gavage study (OECD 414) in rats with the analogue substance C8-10, 1,3-Butandiolester (CAS 853947-59-8) the NOAEL for developmental and maternal toxicity was found to be greater than 1000 mg/kg/day (highest dose tested). For the target substance Fatty acids, C12-18, esters with 1,3-butanediol (CAS 73138-39-3) no reproduction/developmental toxic effects are anticipated based on common predictable ester hydrolysis breakdown products (fatty acids and butylene glycol). Therefore, a NOAEL for developmental toxicity of 1000 mg/kg bw/day is considered for the target substance.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Reference
Data from the source substance C8-10, 1,3-Butandiolester (CAS 853947-59-8) was selected as key results for reasons of structural similarity and data reliability.
Additional data a developmental study is given for the source substance Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1). In this study, the developmental NOAEL in male and female rats was found to be ≥ 900 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 2) studies from reference substances with a common mode of action. Read-across is justified based on different compounds having the same type of effect(s) as described in scenario 2 of the Read-Across Assessment Framework (Read-Across Assessment Framework (RAAF), European Chemicals Agency, Helsinki, Finland, 2017), (please refer to the Analogue Justification for further details provided in IUCLID section 13).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 developmental toxicity of Fatty acids, coco, esters with 1,3 -butanediol (CAS 73138 -39 -3). The assessment was therefore based on studies conducted with analogue 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. Read-across is justified based on different compounds having the same type of effect(s) as described in scenario 2 of the Read-Across Assessment Framework (Read-Across Assessment Framework (RAAF), European Chemicals Agency, Helsinki, Finland, 2017. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
CAS 853947-59-8
A developmental toxicity study was performed according to OECD Guideline 414 under GLP conditions (key study, 2007). 24 female Sprague-Dawley rats were administered the limit dose of 1000 mg/kg bw/day C8-C10-fatty acid-1,3 -butandiolester (CAS 853947-59-8) once daily from day 6 up to day 19 post mating via oral gavage in corn oil as vehicle. No adverse effects on maternal toxicity, developmental toxicity/teratogenicity were observable at the limit dose of 1000 mg/kg/day. The NOAEL for developmental toxicity/teratogenicity and maternal toxicity was found to be ≥1000 mg/kg bw/day.
CAS 91031-31-1
A developmental toxicity study was performed according to OECD Guideline 414 under GLP conditions (supporting study, 1997). 24 female Sprague-Dawley rats per dose were administered 100, 300, or 900 mg/kg bw/day Fatty acids, C16-18; ester with ethylenglycol (CAS 91031-31-1) once daily from gestational day 6 to 15 via oral gavage in 0.5% sodium carboxymethylcellulose and 0.25% Cremophor in aqua dest. as vehicle. No adverse effects on maternal toxicity, developmental toxicity/teratogenicity were observable. The NOAEL for developmental toxicity/teratogenicity and maternal toxicity was found to be ≥900 mg/kg bw/day.
Overall conclusion for developmental toxicity/teratogenicity
Analogue read-across from source substances was applied for the developmental toxicity /teratogenicity endpoint. No effects on reproductive parameters/organs were observed in the available prenatal developmental toxicity studies. The NOAEL for developmental toxicity was found to be 900 mg/kg bw/day. Based on the available data and following the analogue approach, absence of adverse effects on developmental toxicity/teratogenicity is expected for the target substance Fatty acids, coco, esters with 1,3 -butanediol (CAS 73138 -39 -3).
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, coco, esters with 1,3 -butanediol (CAS 73138 -39 -3), 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. Based on the analogue read-across approach, the available data on toxicity to reproduction does not meet the classification criteria according to Regulation (EC) No. 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.
Therefore, based on the analogue read-across approach, the available data do not indicate a hazard for reproduction toxicity.
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.
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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