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EC number: 218-542-3 | CAS number: 2177-70-0
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-03-07 to 2012-03-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks (pretests), 8-9 weeks (main study)
- Housing: all animals of the same group were kept in one cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, 25%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
Treatment of 2 mice with 50 and 100% test item lead to erythema scores of 2-3 and enlarged lymph nodes. In a second pretest, animals treated with 12.5 and 25% test item showed erythema scores of 1.
MAIN STUDY
TREATMENT PREPARATION AND ADMINISTRATION:
The preparations were made freshly for each treatment.
Each test group was treated by topical application to the dorsal surface of each ear with 25 µL/ear/day test item at concentrations of 0, 5, 10 and 25% (w/v) in acetone:olive oil (4+1 v/v) once daily for 3 consecutive days.
5 days after the first topical application (day 6) 250 µL of phosphate-buffered saline containing 19.8 µCi 3-HTdR were injected into each test and control mouse via the tail vein. App. 5 h after injection mice were euthanised. The draining lymph nodes were excised and pooled per group (8 nodes/group). Single cell suspensions were prepared by mechanical disaggregation. Finally, the levels of 3-HTdR incorporation were measured in a beta-scintillation counter.
- Criteria used to consider a positive response:
At least one concentration results in a 3-fold greater 3-HTdR incorporation than in control mice.
The data are compatible with a conventional dose response. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- EC3 values were calculated as follows:
EC3 = (a-c) [(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; with (a,b) and (c,d) being the pairs of coordinates lying immediately above and below the S.I. value of 3 on the dose response plot. - Positive control results:
- experimental result from December 2011:
EC3 = 14.4%; S.I. for 25% = 5.9
The result was in the historical range - Key result
- Parameter:
- SI
- Value:
- 10.51
- Test group / Remarks:
- Experiment 3: 25% (w/v) test substance in acetone: olive oil (4+1 , v/v)
- Key result
- Parameter:
- SI
- Value:
- 4.63
- Test group / Remarks:
- Experiment 2: 10% (w/v) test substance in acetone: olive oil (4+1 , v/v)
- Key result
- Parameter:
- SI
- Value:
- 1.69
- Test group / Remarks:
- Experiment 1: 5% (w/v) test substance in acetone: olive oil (4+1 , v/v)
- Key result
- Parameter:
- SI
- Remarks on result:
- other: 0%: 1.00 5%: 1.69 10%: 4.63 25%: 10.51 EC3 = 7.2%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: background I: 27 dpm background II: 22 dpm 0%: 1929 5%: 3245 10%: 8842 25%: 20036
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this Local Lymph Node Assay PHMA is a dermal sensitiser.
- Executive summary:
In a dermal sensitisation study according to OECD Guideline 429 (adopted 22 July 2010) with PHMA in acetone:olive oil (4+1, v/v), groups of 4 female CBA/CaOlaHsd mice were tested using the LLNA method.
In preliminary tests, the highest concentration not leading to systemic toxicity and excessive local irritation was determined.
Stimulation indices (S.I.) of 1.69, 4.63 and 10.51 were determined with the test substance at concentrations of 5, 10, 25% (w/v) in acetone:olive oil (4+1, v/v), respectively.
The positive control substance was α-Hexylcinnamaldehyde, which resulted in an EC3 of 14.4% (w/v).
A result is regarded as positive when the S.I. is ≥ 3.
Based on these criteria, the test substance was found to be a sensitiser. The EC3 was 7.2%.
In this Local Lymph Node Assay, PHMA is a moderate dermal sensitiser.
Reference
- No deaths occurred during the study.
- No systemic toxicity was observed during the study period. From day 2 to 6, the animals showed erythema of the ear skin (see table below). The animals had the expected gains in body weight during the study period.
Dose group [%], all animals |
Erythema score, day 2/3/4/5/6 (max. score: 4) |
5 |
0/1/1/0/0 |
10 |
0/1/1/1/0 |
25 |
1/1/2/1/1 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
One relevant, reliable (RL=1) study is available for assessment of the sensitising potential of PHMA:
In a dermal sensitisation study according to OECD Guideline 429 (adopted 22 July 2010) with PHMA in acetone:olive oil (4+1, v/v), groups of 4 female CBA/CaOlaHsd mice were tested using the LLNA method.
In preliminary tests, the highest concentration not leading to systemic toxicity and excessive local irritation was determined.
Stimulation indices (S.I.) of 1.69, 4.63 and 10.51 were determined with the test substance at concentrations of 5, 10, 25% (w/v) in acetone:olive oil (4+1, v/v), respectively.
The positive control substance was α-Hexylcinnamaldehyde, which resulted in an EC3 of 14.4% (w/v).
A result is regarded as positive when the S.I. is ≥ 3.
Based on these criteria, the test substance was found to be a sensitiser. The EC3 was 7.2%.
In this Local Lymph Node Assay, PHMA is a moderate dermal sensitiser.
No human information is available for skin sensitisation. However, there is no reason to believe that these results would not be applicable to humans.
There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot be fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerges, this will be taken into account.
Migrated from Short description of key information:
LLNA: sensitising; OECD guideline 429, GLP; Stimulation indices of 1.69, 4.63 and 10.51 at concentrations of 5, 10, 25% in acetone:olive oil (4+1); EC3 = 7.2%
Justification for selection of skin sensitisation endpoint:
OECD guideline study; GLP
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to regulation (EC) 1272/2008, PHMA is classified as moderate skin sensitiser (Category 1 B) and labelled with H317.
According to the former European directive on classification and labelling 67/548/EEC, PHMA is classified as Xi (irritant), R43 (May cause sensitisation by skin contact).
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