Registration Dossier
Registration Dossier
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EC number: 277-225-8 | CAS number: 73018-51-6 The complex combination of hydrocarbons obtained by the acid isomerization of linalool. It consists primarily of monoterpenes, terpene alcohols and oxygenated cyclic compounds.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- A valid in vivo test is available which follows accepted guidance for skin sensitisation.
In addition, this means no further unnecessary animal work is required.
Test material
- Reference substance name:
- Lime Oxide
- IUPAC Name:
- Lime Oxide
- Reference substance name:
- 1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
- EC Number:
- 277-225-8
- EC Name:
- 1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
- Cas Number:
- 73018-51-6
- IUPAC Name:
- 1,6-octadien-3-ol, 3,7-dimethyl-, acid-isomerized
- Reference substance name:
- Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
- IUPAC Name:
- Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Lime Oxide
- Molecular formula: predominantly a mixture of monoterpenes C10H16 and cyclic monoterpene ethers C10H18O
- Molecular weight: monoterpenes C10H16 molecular weight 136.2, cyclic monoterpene ethers C10H18O molecular weight 154.2
- Physical state: clear colorless liquid
- Analytical purity: 61.8%, sum of 4 major peaks
- Impurities: Known impurities are similar in nature to the major components and have empirical formulae of either C10H16 or C10H18O
- Lot/batch No.: SC00009577
- Expiration date of the lot/batch: 13 October 2015
- Storage condition of test material: room temperature, in the dark
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- One to six experimental groups and one control group of six to eight animals.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 3, 10, 30 and 100 %
- Day(s)/duration:
- 21 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- 30%
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 6-8
- Details on study design:
- On day "0" application of 0.1 mL of the test material on the flank skin of 6 to 8 guinea pigs.
Applied repeatedly for 3 weeks or 5 times weekly during 4 weeks.
The application site was left uncovered. - Challenge controls:
- The minimumirritating concentration was used in order to confirm biological activity determined before starting the induction (day -1).
0.025 mL of each concentration was applied to the skin.
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Concentrations higher than 10% induced weak to strong concentration dependant skin irritation. Therefore the maximum concentration considered for skin irritation unaffected by skin irritation was 10%.
At 10% of Lime Oxide in ethanol, no allergic potential was observed under the test conditions and Lime Oxide was well tolerated on the skin of guinea pigs - Executive summary:
No allergic reactions were observed. Therefore no classification is required.
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