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EC number: 205-769-8 | CAS number: 150-76-5
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- 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, acclimatation period or type of sensitization effects
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Concomitant sensitization to hydroquinone and P-methoxyphenol in the guinea pig; inhibitors in acrylic monomers
- Author:
- Van der Walle HB, Delbressine PC and Seutter E
- Year:
- 1 982
- Bibliographic source:
- Contact Dermatitis 1982: 8: 147-154
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- Remarks:
- no all details available
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In vivo test was made in 1982 before the in vitro test strategies.
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:
- p-methoxyphenol, from Aldrich Europe (Beerse, Belgium)
no other data
Constituent 1
In vivo test system
Test animals
- 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
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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)
Challengeopen allclose all
- 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
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: no data
- Group:
- test chemical
- Dose level:
- no data
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: other: no data. Group: test group. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no data.
- Reading:
- other: no data
- Group:
- negative control
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Reading:
- other: no data
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- No data
Any other information on results incl. tables
no other data available
Applicant's summary and conclusion
- Interpretation of results:
- other: In this study, the PMP leads to a moderate sensitization: 5 animals / 10 showing a reaction at day 21 and 35 of challenge.
- Remarks:
- PMP is however officially classified, according to the EU CLP Regulation (EC) n°1272/2008 annex VI (skin sensitizer category 1).
- 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.
PMP is however officially classified, according to the EU CLP Regulation (EC) n°1272/2008 annex VI (skin sensitizer category 1).
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