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EC number: 254-159-8 | CAS number: 38861-78-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 1992 - Mar 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed prior to the implementation of the LLNA method.
Test material
- Reference substance name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-one
- EC Number:
- 254-159-8
- EC Name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-one
- Cas Number:
- 38861-78-8
- Molecular formula:
- C12H16O
- IUPAC Name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: SN 9707
- Expiration date of batch: not available
- Appearance: pale yellow liquid
- Purity: > 95%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was prepared prior to each application on the day of dosing in Alembicol D.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 294 g to 349 g
- Housing: Group housing (10 animals per group)
- Diet: A vitamin C enriched guinea pig diet FD1, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 (light phase from 7 am to 7 pm)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 10% v/v
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- as supplied
- Day(s)/duration:
- Six days after the injection for 48 h
- 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:
- other: Alembicol D
- Concentration / amount:
- 50% v/v
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- as supplied
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
- A preliminary study was performed in order to identify where possible (a) concentrations that will produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritatn concentration by the topical route of adminsitration for the challenge phase
MAIN STUDY
A. INDUCTION EXPOSURE (INTRADERMAL)
- No. of exposures: 1
- Control group: FCA, FCA + V, V
- Site: interscapular area
- Frequency of applications: single application
- Test groups:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation (Ph.Eur.).
2. Test substance, 10% v/v in Alembicol D.
3. Test substance, 10% v/v in a 50:50 mixture of Freund's complete adjuvant and Alembicol D.
- Duration: 0-7 d
INDUCTION EXPOSURE (TOPICAL)
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: TS, TS + FCA, FCA
- Control group: FCA, FCA + V, V
- Site: interscapular area
- Frequency of applications: single application
- Day of topical induction: 6 days after the injections
- Concentrations: 10% v/v in Alembicol D and as supplied
- Duration: 0-7 d
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Two weeks after the topical induction
- Exposure period: 24 h
- Test groups: TS
- Control group: TS
- Site: left flank Test substance (TS), and posterior site 50% v/v Alembicol D
- Concentrations: as supplied and 50% v/v in Alembicol D.
- Evaluation (hr after challenge): 24, 48, 72
- Challenge controls:
- Challenge controls were treated in the same way as test groups.
- Positive control substance(s):
- yes
- Remarks:
- A periodically concurrent positive control (formalin) was used
Results and discussion
- Positive control results:
- The periodic positive control induced hypersensitivity in the test animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- as supplied
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- Erythema (12/20) and oedema (1/20)
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- erythema (3/20)
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- as supplied
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- erythema (18/20) and oedema (7/20)
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- as supplied
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- erythema (18/20) and oedema (7/20)
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- erythema (14/20) and oedema (2/20)
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
CLINICAL SIGNS:
No signs of ill health or toxicity were recorded.
BODY WEIGHT:
Body weight increases were recorded for all guinea pigs over the period of the study.
INDUCTION:
Injections:
Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals. Irritation was seen in test animals at sites receiving the test substance, 10% v/v Alembicol and very slight irritation was observed in control animals receiving Alembicol D.
Topical application:
Slight erythema was observed in test animals following topical application with the test substance, as supplied. Very slight erythema was seen in the control guinea pigs.
CHALLENGE:
The dermal reactions seen in the 17 test animals were more marked than the controls. In one further test animal the dermal reactions were slightly more marked but not clearly different from the maximum reaction seen in the controls. The dermal response seen in the two remaining test animals was similar to the controls.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In this test, performed in twenty albino guinea pigs the test substance produced evidence of skin sensitization (delayed contact hypersensitivity) in seventeen animals. An inconclusive result was recorded in one further animal.
- Executive summary:
A study was performed to assess the skin sensitization potential of the test substance using the guinea pig. The method followed was that described in:
- EPA Health Effects Testing Guidelines, Subpart E - Specific Organ/Tissue Toxicity §798.4100 Dermal sensitization, September 27, 198S (described in Federal Register Vol. 50, No. 188) and subsequent revisions. Subpart E provides detailed information relating to data requirements of 40 CFR Part 798 and supports the Toxic Substances Control Act (TSCA).
- EEC Methods for the determination of toxicity, Directive 84/449/EEC (OJ No. L251, 19 .9 .84), Part B, Method B.6. Acute toxicity (skin sensitization).
- OECD Guideline for Testing of Chemicals No. 406 "Skin Sensitisation". Adopted: 12 May 1981.
- MAGNUSSON, B. and KLIGMAN, A.M. (1970) Allergic Contact Dermatitis in the Guinea-pig: Identification of contact allergens, Thomas, C.C., Springfield, Illinois, U.S.A.
Based on the results of a preliminary study and in compliance with the guidelines, the following dose levels were selected:
Intradermal injection: 10% v/v in Alembicol D.
Topical application: As supplied.
Challenge application: As supplied and 50% v/v in Alembicol D.
Twenty test and twenty control guinea pigs were used in this study. In this study performed using twenty guinea pigs the test substance produced evidence of skin sensitization (delayed contact hypersensitivity) in seventeen test animals. An inconclusive response was observed in one further animal. Based upon the percentage of animals sensitized the test substance is considered to be a Grade III ("Moderate" sensitizer; MAGNUSSON B. and KLIGMAN AM. (1969) The Identification of Contact Allergens by Animal Assay. The Guinea pig Maximisation Test. J. Invest. Derm., 52.3, 268).
The test substance does require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Council Directive 79/831/EEC Annex VI, Part II(D) as described in The Commission Directive 91/325/EEC.
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