Registration Dossier
Registration Dossier
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EC number: 215-185-5 | CAS number: 1310-73-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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
- Justification for non-LLNA method:
- NaOH has been used widely and for a long time and no human cases of skin sensitisation have been reported and therefore NaOH is not considered to be a skin sensitiser (EU RAR 2007). Study was conducted in 1995 before REACH regulatory update (2016/863 and 2016/1688).
Test material
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
- Details on test material:
- TEST SUBSTANCE
NaOH, Hayashi Pure Chemical Ins., Osaka, Japan
Constituent 1
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
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other:
- Group:
- test chemical
- Dose level:
- 0.063-1.0% (induction) after 7 days 0.125% NaOH
- No. with + reactions:
- 0
- Remarks on result:
- no indication of skin sensitisation
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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