Registration Dossier

Toxicological information

Skin sensitisation

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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:
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:
1982
Bibliographic source:
Contact Dermatitis 1982: 8: 147-154

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not applicable
Remarks:
no all details available
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
p-methoxyphenol, from Aldrich Europe (Beerse, Belgium)
no other data

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)

Results
Reading:
other: no data
Group:
test group
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading:

Any other information on results incl. tables

no other data available

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
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 Directive 67/548/EEC annex I (R43), and to the EU CLP Regulation (EC) n°1272/2008 annex VI
(skin sensitizer category 1).


- Cross-reference to other study: not applicable


Classification: sensitizing