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EC number: 204-832-7 | CAS number: 127-25-3
- 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
Endpoint summary
Administrative data
Description of key information
A maximization test was carried out on 25 volunteers.Methyl abietate was tested at a 2% concentration in petrolatum and produced no sensitization reaction. Therefore Methyl abietate (127-25-3) was considered to be not sensitizing in human
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from secondary source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To assess the sensitizing potential of Methyl abietate using the Maximization assay
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- No data available
- Specific details on test material used for the study:
- - Name of the test material: Methyl abietate
- IUPAC name: methyl (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate
- Molecular formula: C21H32O2
- Molecular weight: 316.4818 g/mol
- Substance type: Organic
- Smiles: COC(=O)[C@]1(C)CCC[C@]2(C)[C@H]3CCC(=CC3=CC[C@@H]12)C(C)C - Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- other: No data available
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- No. of animals per dose:
- 25
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Statistics:
- No data available
- Positive control results:
- No data available
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No skin sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- A maximization test was carried out on 25 volunteers.Methyl abietate was tested at a 2% concentration in petrolatum and produced no sensitization reaction. Therefore Methyl abietate (127-25-3) was considered to be not sensitizing in human
- Executive summary:
A maximization test was carried out on 25 volunteers.Methyl abietate was tested at a 2% concentration in petrolatum and produced no sensitization reaction. Therefore Methyl abietate (127-25-3) was considered to be not sensitizing in human.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Skin sensitization
In different studies, Methyl abietate (127-25-3) has been investigated for potential of skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in human and guinea pig for target chemical, Methyl abietate (127-25-3) and its structurally similar read across substancesglyceryl rosinate(8050-31-5)andBis(2-ethylhexyl)adipate (DEHA)(103-23-1). the predicted data using the OECD QSAR toolbox has also been compared with the experimental data of read across
The experimental study conducted by D.L.J. Opdyke (Food and Cosmetics Toxicology, Volume 12, Issues 7–8, December 1974, Page 931)A maximization test was carried out on 25 volunteers. Methyl abietate was tested at a 2% concentration in petrolatum and produced no sensitization reaction. Therefore Methyl abietate (127-25-3) was considered to be not sensitizing in human.
The skin sensitization potential of Methyl abietate (127-25-3) was estimated by SSS (2017) using OECD QSAR toolbox v 3.3 with log kow as the primary descriptor and considering the six closest read across substances Methyl abietate(127-25-3)was predicted to be not sensitizing to the skin of female CBA/CaCrl mouse.
Prediction done using the Danish (Q) SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for Methyl abietate Using Battery algorithm model of Danish QSAR, Allergic Contact Dermatitis for Methyl abietate (127-25-3) estimated to be not sensitizing when applied to human and guinea pig skin.
The experimental study conducted byM. Hausen, A. Krueger, J. Mohnert, H. Hahn and A.Konig(Contact Dermatitis1989: 20: 41-50). Sensitization was carried out by a method containing modifications of the FCA-method and the guinea pig maximization test (GPMT) on Female Albino guinea pigs of the Pirbright white strain, weight 280-350 g, were kept 3 to a cage, at a constant temperature of 22-24°C, a relative humidity of 50-55%, under artificial illumination for 10 h a day, and nourished with Altrornin® and water ad libitum. Readings were performed every day at the same time under the same lighting conditions. 10 animals were used for each substance. The compound was pulverize in a mortar with a pestle and stirred with a magnetic stirrer after the addition of 4 ml of Freund's complete adjuvant until the material became completely dissolved. Then, 4 ml physiological saline was added and an emulsion was prepared by mixing these 2 solvents in a 5 ml syringe until emulsification was complete. Intradermal injections of 6 x 0.1- 0.15 ml of this emulsion, containing 30 mg of test compound, were made in a semicircular arc on the clipped and shaved shoulder area (4 x 6 cm) from left to right, in such a way that the whole quantity of the emulsion was exhausted for the 10 animals (including common losses).This procedure was repeated on the 5th and 9th days, leaving a gap of 2-3 cm between the rows of injection.
In challenge phase, 11 days after induction, open epicutaneous elicitation was performed by applying 0.05 ml of subirritant doses of the compounds to the clipped and shaved right flank of the treated animals. The reactions were read at 24, 48 and 72 h. The mean responses were computed as the quotient of the sum of all reactions obtained divided by the total number of treated animals. Methyl abietate was considered to be a moderate sensitizer.
Also it is further Supported by experimental study conducted byMonice M. Fiume, Bart A. Heldreth(Int J Toxicology. 2004; 23, Suppl 2:55-94.) to evaluate the skin sensitizing potential of read across substanceglyceryl rosinate(8050-31-5)in human.The Maximization assay was conducted to evaluate the sensitization potential of blush containing 2% glyceryl rosinate.27 healthy adult volunteers aged from 18 – 56 years old (11 male and 16 female) were tested. Contact allergy was not observed in any of the subjects during either of the two grading periods (all scores = 0).It was concluded that blush containing 2% glyceryl rosinate(8050-31-5) did not possess a detectable contact sensitizing potential and hence it is considered not skin sensitizing in human.
Also it is further supported by experimental study conducted byOECD SIDS(SIDS Initial Assessment Report for SIAM 10, page no 51, 2000) to evaluate the skin sensitizing potential of read across substanceBis(2-ethylhexyl)adipate (DEHA)(103-23-1). A guinea pig maximization test was carried out on 10 male guinea pig. Bis(2-ethylhexyl)adipate (DEHA)(103-23-1)was tested at a 0.1 %concentration in olive oil. In induction phase intradermal injection given 3times per week for 3 weeks .After 2 weeks rest period challenge dose given. After 24hr of challenge dose evolution was carried out. The average area and height of the reaction at challenge were smaller than during induction was observed. Hence Bis(2-ethylhexyl)adipate (DEHA)(103-23-1) was considered to be not sensitizing in male guinea pig.
Thus based on the above predictions onMethyl abietate (127-25-3) as well as its read across and applying weight of evidence, it can be concluded that Methyl abietate (127-25-3) is not a skin sensitizer. Thus comparing the above studies with the criteria of CLP regulation, Methyl abietate (127-25-3) can be considered as not classified for skin sensitization.
Justification for classification or non-classification
Thus comparing the above studies with the criteria of CLP regulation, Methyl abietate (127-25-3) can be considered as not classified for skin sensitization.
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