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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
In vivo skin and eye irritation tests are performed with the test substance. Under the conditions of these studies, the test item exhibited neither an eye- nor a skin irritation potential.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- Occlusive treatment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 2002)
- Deviations:
- yes
- Remarks:
- Occlusive treatment. Treatment of 4 animals. No data on purity of test substance.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Chemical name: Epoxystearinsaeure-2-ethylhexylester
- Physical state: colorless liquid - Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: adult
- Sex: male
- Weight at study initiation: 2.31 kg (mean)
- Housing: single housing
- Diet: Diet 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod: 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch with test substance, covered with a plastic film and fixed with adhesive plaster
REMOVAL OF TEST SUBSTANCE
- Washing: no data
SCORING SYSTEM:
Draize scheme - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Calculated from the raw data.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Calculated from the raw data.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, the test substance showed no skin irritating potential
- Executive summary:
In a study according to OECD TG 404 (adopted 1981, GLP), the skin irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. The rabbits were treated with 0.5 mL of the undiluted test substance for 4 hours under occlusive conditions. Readings were performed 1, 24, 48, and 72 hours after application. An erythema mean score of 0.5 was calculated from the results after 24, 48, and 72 hours. The findings were fully reversible within 72 h. The corresponding edema score was 0. In conclusion, the test substance showed no skin irritating potential
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
In the original assessment of the study a primary irritation index of 0.5 based on readings after 24, 48, and 72 hours was reported. (PII = Sum of all reactions/(Number of animals*Number of reading time points)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 Mar 1988 - 11 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 1987)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 2002)
- Deviations:
- yes
- Remarks:
- Use of 4 animals and no data on purity of test substance.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Chemical name: Epoxystearinsaeure-2-ethylhexylester
- Physical state: colorless liquid - Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Sex: male
- Age at study initiation: adult
- Weight at study initiation: 2.42 kg (mean)
- Housing: single housing
- Diet: Altromin diet 2023, Altromin GmbH, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod: 12 hrs dark / 12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM:
Draize scheme
READINGS:
1, 6, 24, 48, and 72 hours after application
TOOL USED TO ASSESS SCORE:
fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Conjunctivae findings were observed at 1, 6, and 24 h after treatment. 3/4 animals had a score of 1, 1/4 animals had a score of 2 after 1 hour. After 6 h 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance showed no eye irritating potential
- Executive summary:
In a study according to OECD TG 405 (adopted 1987, GLP), the eye irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. 0.1 mL of the undiluted test substance was instilled into the rabbits eye and no washing was performed. Readings were performed 1, 6, 24, 48, and 72 hours after application. Conjunctivae findings were observed at 1, 6, and 24 h after treatment, where 3/4 animals had a score of 1 and 1/4 animals had a score of 2 after 1 hour. After 6 h, 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
For the test substance in vivo data on skin and eye irritating properties are available. The concerning studies are summarized below.
Skin irritation in vivo
In a study according to OECD TG 404 (adopted 1981, GLP), the skin irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. The rabbits were treated with 0.5 mL of the undiluted test substance for 4 hours under occlusive conditions. Readings were performed 1, 24, 48, and 72 hours after application. An erythema mean score of 0.5 was calculated from the results after 24, 48, and 72 hours. The findings were fully reversible within 72 h. The corresponding edema score was 0. In conclusion, the test substance showed no skin irritating potential (Henkel 1988).
Eye irritation in vivo
In a study according to OECD TG 405 (adopted 1987, GLP), the eye irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. 0.1 mL of the undiluted test substance was instilled into the rabbits eye and no washing was performed. Readings were performed 1, 6, 24, 48, and 72 hours after application. Conjunctivae findings were observed at 1, 6, and 24 h after treatment, where 3/4 animals had a score of 1 and 1/4 animals had a score of 2 after 1 hour. After 6 h, 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours. In conclusion, the test substance showed no eye irritating potential (Henkel 1988).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A GLP-compliant OECD 404 study is available for skin irritation. A GLP-compliant OECD 405 study is available for eye irritation. In both studies, the scores for the test item treated tissues were below the thresholds for classification as an irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008,as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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