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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
Endpoint summary
Administrative data
Description of key information
The test substance was subjected to an acute oral toxicity study, performed in accordance with OECD Guideline 401 (no GLP). The study showed a LD50 of >2000 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- Use of 2000 mg/kg bw as limit dose. Use of 2 animals per sex.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Chemical name: 2-Ethylhexyl-Epoxystearate
- Physical state: liquid, light yellow - Species:
- rat
- Strain:
- Wistar
- Remarks:
- TNO
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen (district Paderborn)
- Age at study initiation: 152 g (females), 174 g (males)
- Weight at study initiation: at least 6 weeks
- Fasting period before study: 15 hours before treatment until 3 hours post-treatment
- Housing: 2 rats per Makrolon cage (type III)
- Diet: Altromin 1324 pellets, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50-70
- Photoperiod: 12 hrs dark / 12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED:
10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations for mortality and symptoms: Several times at the day of application, twice daily afterwards.
- Frequency of weighing: Day -1 before fasting, day of application as well as 48 hours, 1 week, and 2 weeks after application.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Directly after application: piloerection, lethargy Day 2-3: lethargy
- Gross pathology:
- No findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality occurred and no gross pathology findings were observed.
- Executive summary:
In an acute oral toxicity study equivalent to OECD TG 401 (adopted 1981, no GLP), the test substance was administered by oral gavage to two Wistar rats of each sex at 2000 mg/kg bw as a limit dose. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 15 days. Clinical signs of toxicity, body weights as well as gross pathological findings were recorded. Directly after application piloerection and lethargy were observed as clinical signs. Lethargy was present at day 2 and 3 after administration. No animals died on account of the treatment nor did they show severe signs of toxicosis in the 14 observation period. The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg bw.
Reference
Table 1: Development of body weights of rats during the acute oral toxicity study.
Animal No. |
Sex |
Day -1 |
Day of application |
Day 2 |
Day 7 |
Day 14 |
1 |
Male |
182 |
173 |
184 |
203 |
236 |
2 |
Male |
190 |
175 |
186 |
208 |
228 |
1 |
Female |
155 |
149 |
157 |
164 |
166 |
2 |
Female |
164 |
154 |
160 |
156 |
169 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Comparable to guideline study with acceptable restrictions
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- In accordance with column 2 of REACH Annex VIII, testing of the acute toxicity by inhalation is not appropriate as the substance is a liquid with a low vapour pressure (<= 3.6*10-8 atm ( <= 3.7*10-3 Pa; <= 3. 7*10-5 mbar) at 20°C) and inhalation of the substance is unlikely.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (see chapter 7.3.1 Skin irritation and 7.4.1 Skin sensitation).
Additional information
Acute toxicity, oral
In an acute oral toxicity study equivalent to OECD TG 401 (adopted 1981, no GLP), the test substance was administered by oral gavage to two Wistar rats of each sex at 2000 mg/kg bw as a limit dose. All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 15 days. Clinical signs of toxicity, body weights as well as gross pathological findings were recorded. Directly after application piloerection and lethargy were observed as clinical signs. Lethargy was present at day 2 and 3 after administration. No animals died on account of the treatment nor did they show severe signs of toxicosis in the 14 observation period. The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg bw (Henkel 1983).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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.
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