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EC number: 230-566-6 | CAS number: 7195-45-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Bis(2,3-epoxypropyl) phthalate
- EC Number:
- 230-566-6
- EC Name:
- Bis(2,3-epoxypropyl) phthalate
- Cas Number:
- 7195-45-1
- Molecular formula:
- C14H14O6
- IUPAC Name:
- bis(oxiran-2-ylmethyl) phthalate
- Test material form:
- liquid
- Details on test material:
- As defined in Section 1.2 and 1.4.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- A total of five animals were therefore treated at a dose level of300 mg/kg in the study. All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
- Doses:
- 2000 mg/kg bw
300 mg/kg bw - No. of animals per sex per dose:
- 2000 mg/kg bw: 1 female
300 mg/kg bwL 5 females - Control animals:
- no
- Details on study design:
- Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. Due to a technician error the body weight at death was not performed on the animal treated at a dose level of 2000 mg/kg that was humanely killed 4 hours after dosing. At the end ofthe observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Statistics:
- The following computerized system was used in the study:
Delta Controls - ORCA view
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The animal treated at 2000 mg/kg bw was killed for humane reasons, 4 hours after dosing, due to the occurrence of clinical signs of toxicity that approached the severity limit set forth in the UK Home Office
Project Licence. There were no deaths at the 300 mg/kg dose level. - Clinical signs:
- other: At the 2000 mg/kg dose level signs of systemic toxicity noted were hunched posture, pilo-erection, ataxia, ptosis, labored respiration, cyanosis, hypothermia, dehydration and prostration. No signs of systemic toxicity were noted during the observation per
- Gross pathology:
- At the 2000 mg/kg dose level, abnormalities noted at necropsy were dark liver, brown colored lumpy substance (feces) in the stomach and epithelial sloughing of the gastric mucosa and non-glandular epithelium of the stomach. No abnonnalities were noted at necropsy at the 300 mg/kg bw dose level.
Any other information on results incl. tables
Body weight
Dose Level mglkg | Animal Number and Sex | Body Weight (g) at Day | Body Weight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 |
||
300
|
1-0 Female |
152 |
165 |
179 |
13 |
14 |
3-0 Female |
147 |
160 |
179 |
13 |
19 |
|
3-1 Female |
145 |
170 |
181 |
25 |
11 |
|
3-2 Female |
153 |
173 |
187 |
20 |
14 |
|
3-3 Female |
162 |
180 |
193 |
18 |
13 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LDso) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a solution in dimethyl sulphoxide, at a dose level of 300 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. The animal treated at a dose level of 2000 mg/kg was killed for humane reasons, 4 hours after dosing, due to the occurrence of clinical signs of toxicity that approached the severity limit set forth in the UK Home Office Project Licence. There were no deaths at a dose level of 300 mg/kg.
Clinical Observations. Signs of systemic toxicity noted in the animal treated at a dose level of 2000 mg/kg were hunched posture, pilo-erection, ataxia, ptosis, labored respiration, cyanosis, hypothermia, dehydration and prostration. There were no signs of systemic toxicity at a dose level of 300 mg/kg.
Body Weight. Surviving animals showed expected gains in body weight.
Necropsy. Abnormalities noted at necropsy of the animal treated at a dose level of 2000 mg/kg were dark liver, brown colored lumpy substance (feces) in the stomach and epithelial sloughing of the gastric mucosa and non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).
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