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EC number: 701-333-0 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- It is tested in a GLP laboratory.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (24th February 1987)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane
- EC Number:
- 701-333-0
- Molecular formula:
- C11H20O4
- IUPAC Name:
- Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane
- Details on test material:
- It is a UVCB substance.
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species / Strain: Wistar rats (Crl:WI)
Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
Hygienic level: SPF at arrival and kept in a good conventional environment during the study
Number of animals:
(preliminary study) 2 female animals/dose
Number of animals:
(main study) 5 animals/dose
Age of animals: Young adult rats, females are nulliparous and non-pregnant
Sex: full test: 5 female animals/dose followed by 5 male animals/dose (at least one group), limit test: female and male animals
Planned body weight
range at starting: between 200 g and 300 g
Acclimatisation time: at least 5 days
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- not specified
- Details on dermal exposure:
- The back of animals was shaven (approximately 10 % area of the total body surface) 24 hours prior to the treatment. The test item was applied in a single 2000 mg/kg bw dose uniformly over the shaved skin and kept in contact throughout a 24- hour exposure period. Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi occlusive plastic wrap for 24 hours. At the end of the exposure period, residual test item was removed, using an appropriate vehicle at body temperature.
- Duration of exposure:
- A single administration was performed by dermal route and was followed by a 7-day observation period in preliminary study and 14-day observation period in main study.
- Doses:
- The test item was not expected to be lethal at 2000 mg/kg bw on the basis of the results obtained in the preliminary study (no deaths were observed in the preliminary study at 50, 200, 1000 and 2000 mg/kg bw dose levels). Thus, a limit test was performed.
- No. of animals per sex per dose:
- 2000 mg/kg: 2 female animals, 1000 mg/kg: 2female animals, 200 mg/kg: 2female animals, 50 mg/kg: 2 female animals, 2000 mg/kgbw : 5 male and 5 female animals
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred after the 24-hour dermal exposure to Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane in male and female rats during the study.
- Clinical signs:
- other: No behavioural changes or signs of systemic toxicity were noted during the study. Dermal irritation symptom as erythema and other sign as wound and crusting were observed on the treatment site. Slight to well defined erythema (score 1, 2) appeared in thr
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 15. Internal necropsy finding as hydronephrosis on the right side was observed in two male animals (No.: 6729, 6730). This alteration could not be related to the test item toxic effect, but was regarded an individual variation. Severe hydrometra was recorded in three females (No.: 6718, 6720, 6721). The hydrometra is a physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.
- Other findings:
- No death occurred after a single 2000 mg/kg bw dermal dose of Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane. There were no systemic toxic clinical signs and any test item related effect found in body weights and body weight gains during the study. The dermal irritation symptoms observed could be connected with the test item effect. Autopsy revealed no treatment related pathological changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions applied, the acute dermal LD50 value of the test item Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane was estimated to be greater than 2000 mg/kg bw in male and female Crl:WI rats.
- Executive summary:
It is not classified as acute toxicity dermal. No lethality was noted at single dermal dose of 2000 mg/kg bw
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