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Diss Factsheets
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EC number: - | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 2017
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of adipic acid and neodecanoic acid, 2-oxiranylmethyl ester (C31H56O10)+(C32H58O10)+(C33H60O10)
- Molecular formula:
- C32H58O10
- IUPAC Name:
- Reaction product of adipic acid and neodecanoic acid, 2-oxiranylmethyl ester (C31H56O10)+(C32H58O10)+(C33H60O10)
- Reference substance name:
- not yet assigned
- Molecular formula:
- C50H88O16 C51H90O16 C52H92O16
- IUPAC Name:
- not yet assigned
- Reference substance name:
- 2,3-epoxypropyl neodecanoate
- EC Number:
- 247-979-2
- EC Name:
- 2,3-epoxypropyl neodecanoate
- Cas Number:
- 26761-45-5
- Molecular formula:
- C13H24O3
- IUPAC Name:
- (oxiran-2-yl)methyl 2,2-dimethyloctanoate
- Test material form:
- liquid: viscous
- Details on test material:
- Former EC 615-318-0 / CAS: 716336-43-5: changed to EC 825-846-5 / CAS 876528-25-5
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 9 weeks for males
- Weight at study initiation: 209-220 g
- Housing: Before and after exposure period the animals were kept in groups of 3 animals per cage. Duriing the 24-hour exposure the animals were caged individually.
- Diet and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
The intact dorsal skin of the animals was shaved free of hair with a shaver on the day before administration of the test item. The site was situated on the animal´s back between the fore and hind extremities and had an area of at least 5 cm x 6 cm (approx. 1/10 of body surface).
The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips5 on the application site for 24 hours. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw per 30.0 cm² (administration volume 1.89 mL/kg bw)
- No. of animals per sex per dose:
- one dose level with 2 females (plus 1 female for dose range finding)
- Control animals:
- no
- Details on study design:
- Dose range finding (1 female):
The dose level of 2000 mg/kg b.w. was chosen as starting dose as an oral toxicity study with a comparable product resulted in an LD50 above 2000 mg/kg b.w. as stated in the Safety Data Sheet.
Main study (2 females):
Based on the outcome in the range-finding study, the main study was conducted with 2 further animals at the dose level of 2000 mg/kg b.w. to confirm the classification outcome.
Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days.
During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on prematurely deceased animals were made at least once daily to minimize loss of animals during the study. The time of death would have been recorded as precisely as possible. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
The application sites were observed daily and scored using the Draize criteria.
- Necropsy of survivors performed: yes
The classification category for the test item was determined in accordance with the flow chart for the testing procedure given in the OECD Guideline for the Testing of Chemicals No. 402, Annex 2. - Statistics:
- No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).
Results and discussion
- Preliminary study:
- The dose range finding at 2000 mg test item/kg b.w. carried out in 1 female animal did not result in signs of toxicity or premature death.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No skin irritating effects and no pathological changes were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
An acute dermal toxicity study was performed according to OECD TG 402. For the purpose of a limit test 2000 mg/kg of the test item was applied occlusively for 24 hours to the skin of 1 female rat in the dose range finding study and additional 2 female rats in the main study. No mortalities, no clinical signs, no effects on weight development, no skin irritation and no gross pathological findings were observed during the 14-days observation period. The resulting dermal LD50 was thus determined with > 2000 mg/kg bw.
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