Registration Dossier
Registration Dossier
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EC number: 947-389-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The reaction mass consists of three main components. Data on these components have been provided only, whenever they would lead to a classification of the reaction mass.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target chemical:
Reaction mass of 4-methoxyphenol and 4-methoxy-cyclohexanone and 4-methoxy-cyclohexanol
Compositon of the reaction mass:
4-methoxyphenol: ca. 10%
4-methoxy-cyclohexanone: ca. 70%
4-methoxy-cylcohexanol: ca. 20%
Source chemical:
4-methoxyphenol (CAS no. 150-76-5)
4-methoxy-cyclohexanone (CAS no. 13482-23-0)
4-methoxy-cyclohexanol (CAS no. 18068-06-9)
(+)-trans-2-methoxy-cyclohexanol (CAS no. 7429-40-5)
Cyclohexanol (CAS no. 108-93-0)
(For 4-methoxyphenol and 4-methoxy-cyclohexanone registration dossier on ECHA Homepage are available.)
3. ANALOGUE APPROACH JUSTIFICATION
It is assumed that the properties of the reaction mass can be deduced from the properties of its components.
4. DATA MATRIX
See attached justification
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: no information on environmentl conditions, animal ages, acclimatation period or type of sensitization effects
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- older study available
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Olac Ltd. Bicester, England
- Age at study initiation: no data
- Weight at study initiation: 350-450 g
- Housing: 2 per steel cage
- Diet: pellet diet supplemented ad libitum
- Water: containing vitamin C
- Acclimation period: no data - Route:
- intradermal
- Vehicle:
- other: water for injections, and petrolatum, peanut oil or Aramek for challenges
- Concentration / amount:
- 5 x 0.5 M injections for induction no data for challenges (the highest concentration tested was the maximum non irritating concentration (+ 2 lower concentration and the vehicle)
- Route:
- other: epicutaneous
- Vehicle:
- other: 5 x 0.5 M injections for induction no data for challenges (the highest concentration tested was the maximum non irritating concentration (+ 2 lower concentration and the vehicle)
- Concentration / amount:
- 5 x 0.5 M injections for induction no data for challenges (the highest concentration tested was the maximum non irritating concentration (+ 2 lower concentration and the vehicle)
- No. of animals per dose:
- 8
- Details on study design:
- 1st application: Induction 0.5 other: M other: intradermal injections
2nd application: Challenge no data open epicutaneous - Positive control substance(s):
- no
- Positive control results:
- no data
- Reading:
- other: no data
- Group:
- test chemical
- Dose level:
- 0.5 M
- No. with + reactions:
- 4
- Total no. in group:
- 8
- Clinical observations:
- no data
- Interpretation of results:
- sensitising
- Conclusions:
- In a dermal sensitization study with p-methoxyphenol, albino female guinea pigs were tested using the method of Freund's complete adjuvant test. In this study, the PMP leads to a moderate sensitization (4 animals / 8 showing a reaction, but no details done on type of effects).
- Results of test
Induction Challenge
Day 0 to 9 Day 21 Day 35
0.5 M 4/8 4/8
- Hours after challenge: no data
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: no information on environmental conditions, animal ages, acclimatiation period or type of sensitization effects
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- older study available
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Olac Ltd. Bicester, England
- Age at study initiation: no data
- Weight at study initiation: 350-450 g
- Housing: 2 per steel cage
- Diet: pellet diet supplemented ad libitum
- Water: containing vitamin C
- Acclimation period: no data - Route:
- intradermal and epicutaneous
- Vehicle:
- other: petrolatum, peanut oil or Aramek
- Concentration / amount:
- 0.5 M induction day 0 1 M day 7 and no data for challenges (the highest concentration tested was the maximum non irritating concentration
(+ 2 lower concentration and the vehicle) - Route:
- other: epicutaneous semiocclusive on day 21, epicutaneous open on day 35
- Vehicle:
- other: petrolatum, peanut oil or Aramek
- Concentration / amount:
- 0.5 M induction day 0 1 M day 7 and no data for challenges (the highest concentration tested was the maximum non irritating concentration
(+ 2 lower concentration and the vehicle) - No. of animals per dose:
- 10
- Details on study design:
- 1st application: Induction 0.5 other: M other: intradermal injections
2nd application: Induction 1 other: M other: closed patch
3rd application: Challenge no data other: closed patch
TEST SYSTEM
Traditional sensitization test
- route of induction exposure:
intradermal and epicutaneous: intradermal injection for day 0 and patch covered by inpermeable adhesive tape + elastic bandage at day 7
- route of challenge exposure: epicutaneous; semiocclusive on day 21 and open on day 35
aluminium chamber (Finn chamber) or Silver patch, then elastic bandage for day 21, and sites uncovered for day 35
- Vehicle / solvent: peanut oil for injections day 0, ethanol 80 % for induction day 7, and petrolatum, peanut oil or Aramek for challenges
- No. of animals per dose: 10 animals for experimental group and 6 animals for control group
- Details on study design:
RANGE FINDING TESTS: yes
MAIN STUDY A.
INDUCTION EXPOSURE
- No. of exposures: 2 (days 0 and 7)
- type of epicutaneous induction: semi occlusive
- SLS application: yes 10%
- Exposure period: 24h before the closed patch induction on day 7
- Test groups: test substance in FCA
- Control group: same treatment, without test substance for day 0, then vehicule only for day 7
- Site: shoulder region
- Frequency of applications: once
- Duration: 7 day
- Concentrations: 0.5M then 1M
B. CHALLENGE EXPOSURE
- No. of exposures: 2 (days 21 and 35)
- Day(s) of challenge: 14
- Exposure period: 24 h
- Test groups: test substance
- Control group: the control group for the induction is treated for challenge as the experimental group
- Site: right flank for day 21and left one for day 35
- Concentrations: no data
- Evaluation (hr after challenge): 24 h after challenge day 21, then, 24 and 48 h after challenge day 35.
OTHER:
CHALLENGE CONTROLS: not applicable
POSITIVE CONTROL SUBSTANCE(S): no data - Positive control substance(s):
- not specified
- Reading:
- other: no data
- Group:
- test chemical
- Dose level:
- 0.5 M
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Interpretation of results:
- sensitising
- Conclusions:
- In a dermal sensitization study with p-methoxyphenol, albino female guinea pigs were tested using the method of Guinea Pig Maximization Test. In this study, the PMP leads to a moderate sensitization: 5 animals / 10 showing a reaction at day 21 and 35 of challenge.
Data source
Materials and methods
Test material
- Reference substance name:
- Mequinol
- EC Number:
- 205-769-8
- EC Name:
- Mequinol
- Cas Number:
- 150-76-5
- Molecular formula:
- C7H8O2
- IUPAC Name:
- 4-methoxyphenol
- Details on test material:
- IUCLID4 Test substance: no data
Constituent 1
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: no data
- Group:
- test chemical
- Dose level:
- 0.5 M
- No. with + reactions:
- 5
- Total no. in group:
- 10
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
