Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-688-3 | CAS number: 27841-06-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Item 8.7.1, Column 2, a screening study for reproductive / developmental toxicity does not need to be conducted if either a pre-natal developmental toxicity study or an extended one-generation reproductive toxicity study is available. Thus, in accordance with the information provided in Column 2, no reproductive toxicity data are required for the target substance neopentyl glycol dicaprate (CAS 27841-06-1) as a pre-natal developmental toxicity study is available for the analogue source substance decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6). Based on read-across, these data are considered for the assessment of reproductive and developmental toxicity of the target substance.
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
Additional information
There are no studies available for the target substance neopentyl glycol dicaprate (CAS 27841-06-1) assessing its potential to induce effects on reproduction.
Suitable data was read across from a source substance. A short-term (28-day) oral repeated dose toxicity study with the source substance fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7) was performed according to OECD guideline 407 and under GLP conditions (Exxon, 2000). Groups of five male and five female Cr:CD BR rats were exposed to the substance at 100, 300 and 1000 mg/kg bw/day by gavage, 7 days/week for 28 days. The only systemic effect observed was an increased amount of hyaline droplets (the main constituent of which is alpha-2µ-globulin) in the proximal cortical tubular epithelium in male rats treated with 300 and 1000 mg/kg bw/day. This effect is widely accepted to be specific to the male rat and as such is considered to have no relevance to the human. With special regard to reproductive tissues (ovaries, epididymides, prostate, testes and uterus), the examination of organ weights as well as gross pathology and histopathology showed no substance-related findings. Based on the absence of effects up to the highest dose tested, the NOAEL was found to be 1000 mg/kg bw/day.
The available data do not indicate any effect related to reproductive toxicity for the source substance. Therefore, no hazard for toxicity to reproduction is expected for the target substance.
Effects on developmental toxicity
Description of key information
Pre-natal developmental toxicity: dermal (read-across, equivalent/similar to OECD 414): NOAEL (systemic, rat, m/f) = 2000 mg/kg bw/day; NOAEL (development, rat) = 2000 mg/kg bw/day
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: Source: CAS 11138-60-6, Azuka and Daston, 2004
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- local
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- development
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Remarks on result:
- other: Source: CAS 11138-60-6, Azuka and Daston, 2004
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- No potential for developmental toxicity was observed in a study performed with a source substance. As explained in the analogue justification, this result is considered to be valid also for the target substance.
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 adverse effect observed
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- The available information comprises an adequate and reliable (Klimisch score 2) study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profiles. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, Item 8.7, in accordance with Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006 (REACH).
Additional information
No data regarding developmental toxicity / teratogenicity for the target substance neopentyl glycol dicaprate (CAS 27841-06-1) are available. Therefore, the developmental toxicity / teratogenicity endpoint was assessed based on data from the analogue source substance decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6).
Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) was tested in a pre-natal developmental toxicity study equivalent or similar to OECD guideline 414 (Azuka and Daston, 2004). The GLP status was not specified. The test substance was percutaneously applied to Sprague-Dawley rats for 6 h/day under occlusive conditions. 25 animals per sex per dose were treated with 200, 600 or 2000 mg/kg bw/day in corn oil on Days 6 - 15 of gestation. Control animals (25 per sex per dose) received the vehicle. The middle and the high dose levels caused some local irritation at the site of application, but no decreases in maternal weight gain or food consumption. There were no differences from control in any of the developmental parameters measured, including embryo/fetal viability, fetal weight, malformations, or variations. Therefore, a NOAEL of 2000 mg/kg bw/day was derived for pre-natal development and for systemic maternal toxicity. Due to the irritation effects on skin, the local maternal NOAEL was found to be 200 mg/kg bw/day.
The available data do not indicate a developmental toxicity / teratogenic potential after dermal application for the source substance. Therefore, no hazard for developmental toxicity / teratogenicity is expected for the target substance.
Justification for classification or non-classification
The available data on developmental toxicity and teratogenicity of the analogue source substance decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) do not meet the classification criteria according to the CLP Regulation (EC) No. 1272/2008. Based on read-across, also no classification is warranted for the target substance neopentyl glycol dicaprate (CAS 27841-06-1). Data are, therefore, conclusive but not sufficient for classification.
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.