Registration Dossier
Registration Dossier
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EC number: 931-319-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to the OECD SIDS document for sodium hydroxide (March 2002), a Klimisch 2 reliability score was assigned since the study is well documented, meets generally accepted scientific principles, and is acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- A study of skin responses to follow-up, rechallenge and combined effects of irritants using non-invasive measurements
- Author:
- Park et al.
- Year:
- 1 995
- Bibliographic source:
- Journal of Dermatological Science, 10, 159-165
Materials and methods
- Principles of method if other than guideline:
- Patch testing for 24 hours with visual scoring being recorded by the subjective evaluation method and by the transepidermal water loss method. After the seventh day reading sodium hydroxide (0.125%) was re-applied to all pretested sites and reading was performed on the next day.
- GLP compliance:
- no
- Type of study:
- not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- TEST SUBSTANCE
NaOH, Hayashi Pure Chemical Ins., Osaka, Japan
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- HUMAN VOLUNTEERS
- Age at study initiation: between 20 and 25
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- Concentrations used for induction: 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- Concentrations used for induction: 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
- No. of animals per dose:
- Number of volunteers: 15 without any previous history of atopy
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Control group: yes, distilled water and empty chambers
- Site: back
- Duration: 24 hours (induction and challenge)
- Concentrations: 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
B. CHALLENGE EXPOSURE
- No. of exposures: on day 7, NaOH was reapplied
- Day(s) of challenge: 1
- Concentrations: 0.125%
Results and discussion
Any other information on results incl. tables
The irritant response was well correlated to the concentration of the
irritant. However, increased response was not observed when subclinical
doses were rechallenged on the previously patch tested sites.
Applicant's summary and conclusion
- Conclusions:
- Not sensitizing
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