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EC number: 695-619-1 | CAS number: 623-72-3
- 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, other
- Remarks:
- Skin sensitization study of mouse(BrdU-ELISA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022-03-21 ~ 2022-05-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline for Testing of Chemicals: TG 442B Skin Sensitization: Local Lymph Node (Adopted: 25 June 2018)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: This study was performed to investigate skin sensitization of Ethyl 3-hydroxy propanoate in mouse(BrdU-ELISA).
Test material
- Reference substance name:
- ethyl 3-hydroxypropanoate
- Cas Number:
- 623-72-3
- Molecular formula:
- C5H10O3
- IUPAC Name:
- ethyl 3-hydroxypropanoate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Remarks:
- CBA/JCrHsd, Mouse, SPF
- Sex:
- female
- Details on test animals and environmental conditions:
- - Species/strain/sex : CBA/JCrHsd, Mouse, SPF, Female
- Supplier : KOATECH Co., Ltd.(181-21, Jinwi-ro, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, Korea)
- Number of animals : Female, 11 animals(Pre-screen test) : Female, 32 animals(Main test)
- Body weight at the time of allocation : 8 weeks old, 19.18 g – 21.15 g(Pre-screen test) 8 weeks old, 19.24 g – 21.36 g(Main test)
- Number of test animals : Female, 10 animals(Pre-screen test) Female, 30 animals(Main test)
- Body weight at the time of allocation : 9 weeks old, 21.21 g – 23.54 g(Pre-screen test)
9 weeks old, 21.44 g – 23.99 g(Main test)
Results and discussion
- Positive control results:
- The test substance(The vehicle control and the positive control) was spread over the
entire dorsal surface of the ear using a micropipette at a volume of 25 μL/ear.
The stimulation index was calculated to be 2.3 for the positive control substance.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- other: BrdU L.I. (BrdU labelling Index)
- Value:
- 100 %
- At concentration:
- 0.091 other: L.I.
- Cell viability:
- S.I. (Stimulation Index) = Mean of BrdU L.I. in test substance group / Mean of BrdU L.I. in negative
control group
0.5 S.I. - Vehicle controls validity:
- not valid
- Negative controls validity:
- not valid
- Positive controls validity:
- not valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- other: BrdU L.I. (BrdU labelling Index)
- Value:
- 50 %
- At concentration:
- 0.119 other: L.I.
- Cell viability:
- S.I. (Stimulation Index) = Mean of BrdU L.I. in test substance group / Mean of BrdU L.I. in negative
control group
0.7 S.I. - Vehicle controls validity:
- not valid
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- other: BrdU L.I. (BrdU labelling Index)
- Value:
- 25 %
- At concentration:
- 0.129 other: L.I.
- Cell viability:
- S.I. (Stimulation Index) = Mean of BrdU L.I. in test substance group / Mean of BrdU L.I. in negative
control group
0.7 S.I. - Vehicle controls validity:
- not valid
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- 1. Clinical signs
Mice were observed for clinical signs daily.
2. Body weight
Body weights were recorded on Day 1(Immediately prior to dosing) and on Day 6.
3. Ear thickness
Ear thickness measurements were performed on Day 1 prior to dosing, on Day 3 before the test substance application and on Day 6 before sacrifice.
4. Observation of test substance application site
Skin responses at the site of test substance application were observed once each day according to “Erythema scores”.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The stimulation index(S.I.) was calculated to be 0.7, 0.7 and 0.5 for the 25 %(v/v) (G3), 50 %(v/v)(G4) and 100 %(G5) treatment groups, respectively. The positive control group(G6) has an S.I. of 2.3.
As a result of the this study, Ethyl 3-hydroxypropanoate a test substance in skin sensitization tests on mice, is considered to be a non-inducing substance for skin sensitization. - Executive summary:
This study was conducted to evaluate the skin sensitisation of Ethyl 3-hydroxy propanoate in mouse (BrdU-ELISA). Parameters measured during study period were
mortality, clinical signs, body weight changes, ear thickness and skin reactions.
No mortality was observed in the study. The body weight of the animals in the treatment groups did not deviate from the solvent control.
As a result of observing the local region treated with the test substance, no skin irritation was observed and no significant increase of ear thickness was induced by
the test substance.
The stimulation index(S.I.) was calculated to be 0.7, 0.7 and 0.5 for the 25 %(v/v) (G3), 50 %(v/v)(G4) and 100 %(G5) treatment groups, respectively. The positive control
group(G6) has an S.I. of 2.3.
As a result of the this study, Ethyl 3-hydroxypropanoate a test substance in skin sensitization tests on mice, is considered to be a non-inducing substance for skin
sensitization.
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