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EC number: 201-061-8 | CAS number: 77-83-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- A Magnusson B, Kligman AM (1970) scientifically justified allergic contact dermatitis in the guinea pig has been conducted.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Magnusson B, Kligman AM (1970) Allergic contact dermatitis in the guinea pig: Identification of contact allergens. CC Thomas, Springfield, IL
- Deviations:
- not specified
- Principles of method if other than guideline:
- Guinea pig maximisation test; induction via intradermal and occluded patch; 4 challenge exposures at different concentrations on different days.
- GLP compliance:
- no
- Remarks:
- Not fully compliant with GLP because the test substance was not subjected to characterisation, homogeneity and stability studies.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A Magnusson B, Kligman AM (1970) scientifically justified allergic contact dermatitis in the guinea pig has been conducted.
Test material
- Reference substance name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- EC Number:
- 201-061-8
- EC Name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- Cas Number:
- 77-83-8
- Molecular formula:
- C₁₂H₁₄O₃
- IUPAC Name:
- ethyl 3-methyl-3-phenyloxirane-2-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): Ethyl methyl phenyl glycidate
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: Sample reference: S14417T1
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Intradermal injections - 0.1 % dodecylbenzene sulphonate (DOBS) in 0.9 % physiological saline; occluded patch applications - none
- Concentration / amount:
- Intradermal injection induction - 2.0 %; occluded patch induction application - 100 %; occluded patch first challenge application - 100 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Intradermal injections - 0.1 % dodecylbenzene sulphonate (DOBS) in 0.9 % physiological saline; occluded patch applications - none
- Concentration / amount:
- Intradermal injection induction - 2.0 %; occluded patch induction application - 100 %; occluded patch first challenge application - 100 %
- No. of animals per dose:
- Test group - 10; treated control group - 4; untreated control group - 4
- Details on study design:
- PRELIMINARY INTRADERMAL INJECTION TEST
- No. of animals: 4 female
- Exposure period: 24 hr
- Observations: skin reactions examined, reactions measured in size.
- 2 % test substance in 0.01 % DOBS/saline was selected for intradermal injection induction as it was suitably irritant.
PRELIMINARY OCCLUDED PATCH TEST
- No. of animals: 8 male in 2 groups of 4.
- Exposure period: 24 hr
- Observation period: 48 hr, observations at 24 hr and 48 hr.
- Concentrations: Group 1 - 5.0 %, 10.0 %, 25.0 %. Group 2 - 50.0 %, 100.0 %
- 100 % test substance was selected for both the induction and challenge applications.
MAIN STUDY
- No. of animals: 10 (6 male, 4 female).
- Weight at study initiation: 284 g to 370 g.
A. INTRADERMAL INJECTION INDUCTION
- No. of exposures: 1
- Site: Hair clipped from 2 cm × 4 cm region of dorsal shoulder.
- Injections into the prepared site as follows:
-- 2 × 0.1 mL injections of 50 % Freund's Complete Adjuvant (FCA) in 0.9 % saline
-- 2 × 0.1 mL injections of 2 % test substance in 0.01 % DOBS/saline
-- 2 × 0.1 mL injections of 4 % test substance in 0.01 % DOBS/saline mixed 50:50 with FCA so that concentration of test substance was 2 %.
B. OCCLUDED PATCH INDUCTION
- Period: 1 week after Intradermal Injection Induction
- Site: same site clipped and shaved
- 2 cm × 4 cm filter paper patch, attached to a 4 cm × 6 cm piece of polythene, was saturated with neat test substance and patch applied to site.
- Exposure period: 48 hr
C. CHALLENGE EXPOSURES
- No. of challenge exposures: 4
- Days of challenges:
-- 1: day 0 (14 days after the occluded patch induction)
-- 2: day 7
-- 3: day 15
-- 4: day 22
- Concentrations:
-- 1: 100 % test substance
-- 2: 10.0 % and 1.0 % test substance in acetone/PEG 400
-- 3: 0.1 % and 0.001 % test substance in acetone/PEG 400
-- 4: 1.0 % and 0.1 % test substance in acetone/PEG 400
- Site: same site clipped and shaved
- 8 mm diameter filter paper patch in an 11 mm aluminium patch test cup was saturated with challenge material and patch applied to site.
- Exposure period: 24 hr
- Evaluations: 24 hrs and 48 hrs after challenge.
- Scoring system:
-- 0: No reaction
-- 0.5: Very feint erythema (usually non-confluent)
-- 1: Faint erythema (usually confluent)
-- 2: Moderate erythema
-- 3: Marked erythema (with or without oedema)
-- sp: Small spots of erythema
-- n: Necrosis
-- w: White centre or spots - Challenge controls:
- - No. of animals: 16
-- 4 treated controls for 1st challenge
-- 4 treated controls for 2nd challenge.
-- 4 untreated controls for 3rd challenge.
-- 4 untreated controls for 4th challenge.
- Treated animals received four intradermal injections of 50 % Freunds Complete Adjuvant in 0.01 % DOBS/saline followed 7 days later by a 48 hour occluded patch of the test solvent over the injection sites.
- Each group of 4 animals was treated to 1st, 2nd, 3rd and 4th challenge exposures as per the test animals. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: 1st challenge (day 0)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 1st challenge (day 0). . Hours after challenge: 24.0. Group: test group. Dose level: 100.0 %. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 1st challenge (day 0)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 1st challenge (day 0). . Hours after challenge: 48.0. Group: test group. Dose level: 100.0 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 2nd challenge (day 7)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10.0 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 2nd challenge (day 7). . Hours after challenge: 24.0. Group: test group. Dose level: 10.0 %. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 2nd challenge (day 7)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10.0 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 2nd challenge (day 7). . Hours after challenge: 48.0. Group: test group. Dose level: 10.0 %. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 2nd challenge (day 7)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 2nd challenge (day 7). . Hours after challenge: 24.0. Group: test group. Dose level: 1.0 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 2nd challenge (day 7)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 2nd challenge (day 7). . Hours after challenge: 48.0. Group: test group. Dose level: 1.0 %. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 3rd challenge (day 15)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd challenge (day 15). . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 3rd challenge (day 15)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd challenge (day 15). . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 3rd challenge (day 15)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.001 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd challenge (day 15). . Hours after challenge: 24.0. Group: test group. Dose level: 0.001 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 3rd challenge (day 15)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.001 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd challenge (day 15). . Hours after challenge: 48.0. Group: test group. Dose level: 0.001 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 4th challenge (day 22)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 4th challenge (day 22). . Hours after challenge: 24.0. Group: test group. Dose level: 1.0 %. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 4th challenge (day 22)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- 1 additional questionable reaction
- Remarks on result:
- other: Reading: other: 4th challenge (day 22). . Hours after challenge: 48.0. Group: test group. Dose level: 1.0 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: 1 additional questionable reaction.
- Key result
- Reading:
- other: 4th challenge (day 22)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 4th challenge (day 22). . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: 4th challenge (day 22)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- 1 additional questionable reaction
- Remarks on result:
- other: Reading: other: 4th challenge (day 22). . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: 1 additional questionable reaction.
- Reading:
- other: Challenge 1
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 1
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 2
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 2
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: challenge 3
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 3
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.001%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.001%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 4
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 4
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 4
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge 4
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Strong skin sensitisation was seen with challenges of 100.0 %, 10.0 % and 1.0 % test material solution, a weak response was seen at 0.1 %, and no response was seen at 0.001 %.
There were no reactions observed in the treated control groups for challenges 1 and 2. One animal in the group for challenge 2 was killed and not scored as it suffered a broken leg. There were also no reactions observed in the untreated control group for challenges 3 and 4.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The test material was shown to be strongly sensitising in a guinea pig maximisation test.
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