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EC number: 241-045-8 | CAS number: 16969-10-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August -September 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- The Guinea pig maximization test
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA study was available before the REACH registration.
Test material
- Reference substance name:
- 2-hydroxy-3-phenoxypropyl acrylate
- EC Number:
- 241-045-8
- EC Name:
- 2-hydroxy-3-phenoxypropyl acrylate
- Cas Number:
- 16969-10-1
- Molecular formula:
- C12H14O4
- IUPAC Name:
- 2-hydroxy-3-phenoxypropyl acrylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name used in the study report: Phenylglycidetheracrylat
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Randomization: yes
TEST ANIMALS
- Source: Lippische Versuchstierzucht
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 256-309 g
- Housing: Makrolon, type IV , 5/cage
- Diet (e.g. ad libitum): Kliba 341.4 mm, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: not specified
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): not specified ("fully air-conditionned rooms")
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 2%
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 10%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 5%
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 5%
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Main test: 10 females on control groups, 20 females on tested groups
- Details on study design:
- RANGE FINDING TESTS: yes.
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application: flank, respective on the same area
Number of test animals: 4 per test concentration
Readings: about 24 and 48 h after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction :
- Test groups: 6 intradermal injections
A/ Front row : 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with water in a ratio of 1:1
B/middle row: 2 injections each of 0.1 ml of the test substance formulation
C/back row: 2 injections each of 0.1 ml Freund's adjuvant/water (1:1) with the test substance
- Control groups 1 and 2: The animals were given the same injections (A, B C) but without test substance, only with the formulating agent.
- Site of application: shoulder
- Duration: not application
- Reading 24h after the beginning of application
Percutaneous induction was carried out about one week after interdermal induction
- Exposure: 2x4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing. The animals were exposed to about 0.3 g of the test substance formulation.
- Duration: 24h
- Reading 48h after the beginning of application
B. CHALLENGE EXPOSURE
- Day(s) of challenge: First challenge, 14 days after percutaneous application, Second challenge one week later.
- Site: intact clipped flank
- Concentrations: non-irritant concentration
2x2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing. The animals were exposed to about 0.15 g of the test substance formulation.
1st challenge: treatement of the test group and control group 1 with the test substance formulation. Additionally olive oil was applied as a vehicle. Control control 2 received only olive oil.
2nd challenge: treatement of the test group and control groups 1 and 2 with the test substance formulation. Additionally olive oil was applied as a vehicle.
-Duration of exposure: 24h
- Evaluation (hr after challenge): 24-48-72h after the begining of application
- Challenge controls:
- yes
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group 1
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
The number of animals with skin findings after the first challenge (20 days after intradermal induction) and after the second challenge (27 days after intradermal induction is summarized in the following table (reading at 48h after the beginning of application):
1st challenge |
1st challenge |
2nd challenge |
2nd challenge |
|
|
5% in olive oil |
olive oil |
5% in olive oil |
olive oil |
control group 1 |
0/10 |
0/10 |
6/10 |
0/10 |
control group 2 |
n/a |
0/10 |
0/10 |
0/10 |
test group |
17/20 |
0/20 |
18/20 |
0/20 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under these test conditions, Phenylglycidetheracrylat has a sensitizing effect on the skin of the guinea pigs.
- Executive summary:
The substance Phenylglycidetheracrylat was tested for its sensitizing effect an the skin of the guinea pig in the maximization test based an the method of Magnusson and Kligman. After intradermal induction distinct erythema and edema were observed at the injection sites of the control animals and the test animals, at which only Freund's adjuvant/aqua dest (1 : 1) was applied. Injection of test substance preparation in olive oil caused distinct erythema and edema in the test animals. The injection sites, which were applied with test substance preparation in Freund's adjuvant/aqua dest. (1 : 1> exhibited necrotic skin changes and distinct edema. The control animals, injected with olive oil (vehicle) showed distinct erythema.
After percutaneous induction necrotic skin changes (caused by the intradermal induction) were observed in addition to distinct edema in the test animals. The animals of control group one and two which were applied with olive oil (vehicle) exhibited incrustation, partially open (caused by the intradermal induction) in addition to distinct erythema and edema.
After the first challenge (48 hours after the beginning of application) with the 5% test substance preparation in olive oil, 4 out of 20 test animals showed severe erythema in addition to slight edema. 12 out of 20 test animals exhibited distinct erythema, 2 of them also showed edema. One out of 20 test animals showed slight erythema. Control group 1 didn't show any skin reactions.
The second challenge (48 hours after the beginning of application) with the 5% test substance preparation in olive oil caused distinct erythema in 6 out of 20 test animals, 3 of them showed scaling and one of these 3 animals also exhibited slight edema. In 12 out of these 20 test animals slight erythema could be observed. One out of 20 test animals showed scaling. 6/10 animals of control group 1 exhibited slight erythema. Control group 2 didn't show skin reactions.
Olive oil which was applied as a vehicle didn't cause any skin reactions in all animals after the first challenge (48 hours after the beginning of the application). After the second challenge olive oil caused scaling in 6/20 test animals. Control group 1 and 2 did not show any skin changes.
Under these test conditions and following the results described above, Phenylglycidetheracrylat has a sensitizing effect on the skin of the guinea pigs.
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