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EC number: 204-317-7 | CAS number: 119-36-8
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Studies in Animals:
Table 1 summarises the data from skin sensitisation studies on MeS in animals according to a variety of protocols. Concentrations tested ranged from those likely to be used in consumer products up to the undiluted test substance. All maximisation studies in guinea pigs reported MeS as not sensitising. According to the Substance Evaluation (SEV) Conclusion document from March 2021, the Evaluating Member State (France) has considered that the negative Maximisation studies available on MeS had methodological limitations, in particular a low number of animals tested that could decrease the sensitivity of the Maximisation tests (RIFM, 1981, cited in CIR, 2003 and in Lapczynski et al., 2007; Kimber et al., 1991; Klecak et al., 1977).
All LLNA studies at concentrations up to 20% reported MeS as not sensitising. Three studies reported that MeS is sensitising at the higher concentrations of 25% (Montelius, 1994), 50% (Montelius, 1998), or 80% (Adenuga et al., 2012). On the other hand, two studies (Ashby, 1995; Arts, 1996) reported MeS as not sensitising at 25%, while another (Basketter, 1998) reported MeS as not sensitising even at 100%.
The majority of the published LLNA studies describe testing of sets of chemicals during the validation of the LLNA as a regulatory test protocol. MeS was included in such studies as an irritant substance, rather than as a sensitiser. Although MeS is not classified as a skin irritant, it does exhibit a mild degree of skin irritancy. Skin irritancy is reported to be one possible cause of “false positive” results in the LLNA (Basketter et al, 1998; Basketter & Kimber, 2007). Some variation in test results could be due to the different solvent vehicle used in the studies, the concentrations tested and some variations in the protocols used. Overall, the animal studies indicate that MeS can be considered to have at most a weak sensitising potential.
Table 1: Skin Sensitisation studies on MeS in animals
Method
Concentration
Species
Result
Reference
Maximisation
Intradermal induction: 2.5% in DOBS/FCA
Topical induction: 100%
Challenge: 10% in acetone/PEG
Guinea pig
Not sensitising
Kimber, 1991
Basketter, 1992
Maximisation (screening)
Intradermal induction: 5% in water
Topical induction: 60% in water
Challenge: 20% in water
Guinea pig
Not sensitising
Longobardi, 2001
Maximisation
Intradermal induction: 1% in FCA
Topical induction: 40% in acetone
Challenge: 10% in acetone
Guinea pig
Not sensitising
RIFM, 1981 (Cited in CIR, 2003)
Maximisation
Intradermal induction: 5% in FCA
Topical induction: 25% in petrolatum
Challenge: sub-irritant in petrolatum
Guinea pig
Not sensitising
Klecak, 1977
Open epicutaneous
Induction: up to at least 30%
Challenge: 1%
vehicle not stated
Guinea pig
Minimum sensitising conc. 30%
Klecak, 1977
Open epicutaneous
8%
Guinea pig
Not sensitising
Klecak, 1979, 1985
Closed epicutaneous
Induction: 30%
Challenge: 1%
Guinea pig
Not sensitising
Ishihara, 1986
Draize
Induction & challenge: 0.1% in isotonic saline
Guinea pig
Not sensitising
Klecak, 1977
Freund’s Complete Adjuvant
50% in FCA
Guinea pig
Not sensitising
Klecak, 1977
Optimization
Induction: 0.1% in saline or FCA/saline
Intradermal challenge: 0.1% in saline
Topical challenge: 10% in petrolatum
Guinea pig
Intradermal challenge: 2/20 sensitisation reactions
Topical challenge: no sensitisation
Maurer, 1980
LLNA
25, 50, 100% (vehicle not specified)
Mouse
Not sensitising
Basketter, 1998
LLNA
10, 20, 25, 50, 100% in DMF or MEK
Mouse
Sensitising 50%
EC3: 28% (DMF)
Montelius, 1994
LLNA
5, 12.5, 25% in AOO
Rat
Not sensitising
Arts, 1996
LLNA
1, 10, 25% in DMF or MEK
Mouse
Sensitising 25%
SI 3.0 with DMF
SI 7.5 with MEK
Montelius, 1994
LLNA
5, 10, 25% in AOO
Mouse
Not sensitising
Ashby, 1995
LLNA
20% in AOO
Mouse
Not sensitising
Kimber,1998
LLNA
10%
Mouse
Not sensitising
Maurer, 1980
LLNA
5%
Mouse
Not sensitising
Gerberick, 1992
LLNA
20, 40, 80% in 4:1 mixture of acetone and olive oil
Mouse
Sensitising 80%
SI > 3
EC3: 48.15
Adenuga, 2012
Studies in Humans:
Volunteer Induction Studies
Results of human volunteer induction studies conducted by RIFM and summarised in Lapczynski et al. (2007) are shown in Table 2. No instances of positive reactions were reported.
Table 2: Human Volunteer Sensitisation Studies on MeS
Method
Concentration
Result
Reference
Maximisation
12% in petrolatum
0/25
RIFM, 1976
Maximisation
8% in petrolatum
0/27
RIFM, 1973
HRIPT
1.25% (vehicle not stated)
0/39
RIFM, 1964
Diagnostic Studies
Consumer use of preparations containing low concentrations of MeS has been widespread over many years. A number of diagnostic studies in patients with skin conditions have been reported and summarised in Lapczynski et al. (2007). The results are shown in Table 3. Only very low percentages of positive reactions to MeS were reported in patients with pre-existing dermatitis/eczema. In contrast, the SEV has concluded that 7 out of the 8 diagnostic studies demonstrated positive reactions after patch testing (Romaguera, 1980; de Groot et al., 2000; Rudner, 1977; Ferguson, 1984; Mitchell et al., 1982; Nethercott et al., 1989; Addo et al., 1982; Stingeni et al., 1995). In addition, two individual cases of skin sensitisation to MeS are reported in the literature (Oiso et al., 2004; Hindson, 1977).
Table 3: Human Diagnostic Studies on MeS
Number of patients
Tests
MeS Concentration
No. +ve reaction
% +ve reaction
Ref.
4600: (2784 contact dermatitis; 189 dermatitis of hands; 135 photoallergy; 1491 healthy
Patch tests in which ICDRG series were included
2% in petrolatum
6
0.13
(0.19 excluding healthy subjects)
Romaguera, 1980
183
A1 Test® strips or Finn Chambers®
2%
1.6
Rudner, 1977, 1978
241
Finn Chambers®
2% in yellow soft paraffin
3
1.2
Ferguson, 1984
585 eczema patients
Not specified
2% in petrolatum,
3
Mitchell, 1982
19 with eyelid dermatitis
A1 Test® strips or Finn Chambers®
1% in petrolatum
0
Nethercott, 1989
70 with dermatitis other sites
A1 Test® strips or Finn Chambers®
1% in petrolatum
1.4
Nethercott, 1989
197
Closed patch tests
0.05-0.5% in base cream or 99% ethanol
4
2
Takenaka, 1986
1825
“Internationally accepted criteria”
2% in petrolatum
7
0.4
De Groot, 2000
50 with photosensitivity dermatitis with actinic reticuloid syndrome
Closed patch test
2% in paraffin
1
2
Addo, 1982
32 with polymorphic eruption
Closed patch test
2% in paraffin
0
0
Addo, 1982
457 with contact dermatitis
Closed patch test
2% in paraffin
0
0
Addo, 1982
267 health care employees with contact dermatitis
Patch test
2% in petrolatum
0
0
Stingeni, 1995
4
Patch test
2% in olive oil or arachis oil
1
25
Hindson, 1977
1
Closed patch test
2% in olive oil
1
100
Oiso, 2004
Conclusion:
Overall, the weight of evidence from both animal tests and human data suggests that MeS may have, at most, weak skin sensitisation potential. However, the evaluating Member State Competent Authority (MSCA) has considered MeS as a skin sensitiser. In this context, a C&L proposal to classify methyl salicylate as Skin Sens. 1B based on animal and human data was submitted, and then agreed by the Risk Assessment Committee (RAC). Therefore, the substance MeS is now subject to a harmonised classification as Skin Sens. 1B in accordance with the Commission delegated regulation (EU) 2021/849 of 11 March 2021 (i.e., the 17th adaptation to technical and scientific progress). The available studies are considered sufficient to fulfil this endpoint.
Short description of key information:
The skin sensitisation potential of MeS has been examined in many studies in several test systems. All maximisation studies in guinea pigs, the majority of studies by other protocols in guinea pigs and the majority of LLNA studies in mice give a non-sensitising result, however three LLNA studies indicated MeS as a moderate sensitiser. No key study has been chosen for this endpoint. Instead, an assessment has been made by weight of evidence, taking into account the most relevant studies in animals as well as human induction and diagnostic studies.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There have been no reports of respiratory sensitisation from either the manufacture or the use of MeS over many years of human experience. No experimental information is available or required for this endpoint
Short description of key information:
There are no data which indicate that MeS has respiratory sensitisation potential.
Justification for classification or non-classification
Skin sensitisation:
All studies in guinea pigs and all LLNA studies at concentrations up to 20% reported MeS as not sensitising. Three LLNA studies reported MeS as sensitising at higher concentrations of 25, 50 or 80%. On the other hand, two studies reported MeS as not sensitizing at 25%, and another reported MeS as not sensitising even at 100%.
Human volunteer induction studies reported no instances of positive reactions. Consumer use of preparations containing low concentrations of MeS is widespread. In diagnostic studies on patients with skin conditions, only very low percentages of positive reactions to MeS were reported. In contrast, the SEV has concluded that 7 out of the 8 diagnostic studies demonstrated positive reactions after patch testing. In addition, two individual cases of skin sensitisation to MeS are reported in the literature.
The weight of evidence from both animal tests and human data suggests that MeS may have, at most, weak skin sensitisation potential. However, in the context of CLH proposal, the evaluating MSCA has considered MeS as a skin sensitiser.
A harmonised classification as Skin Sens. 1B (H317: may cause an allergic skin reaction) based on animal and human data was submitted, and then agreed by the RAC. Therefore, the substance MeS is now subject to a harmonised classification as Skin Sens. 1B according to the Commission delegated regulation (EU) 2021/849 of 11 March 2021 (i.e., the 17th ATP) and in accordance with the criteria of UN/EU GHS.
Respiratory sensitisation:
There have been no reports of respiratory sensitisation from either the manufacture or the use of MeS over many years of human experience. MeS is therefore not classified for respiratory sensitisation according to the criteria of UN/EU GHS.
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