Sodium methanolate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting 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:

1995

Bibliographic source:

Journal of Dermatological Science, 10, 159-165

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

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

Test material

Test material information

Constituent 1

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:

- Name of test material (as cited in study report): NaOH
- Analytical purity: no data
- Source: Hayashi Pure Chemical Ins., Osaka, Japan

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 15
- Sex: male
- Age: between 20 and 25 y

Clinical history:

- History of allergy or casuistics for study subject or populations: without any previous history of atopy

Controls:

distilled water and empty chambers

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
A. INDUCTION EXPOSURE
- Control group: yes, distilled water and empty chambers
- Site: back
- Duration: 24 hours (induction and challenge)
- Concentrations: 1.0, 0.5, 0.25, 0.125 and 0.063% (1.0% NaOH was serial diluted as a half to obtain 5 different solutions)
- Ammount of substance applied: 50 µL

B. CHALLENGE EXPOSURE
- No. of exposures: on day 7, NaOH was reapplied
- Day(s) of challenge: 1
- Concentrations: 0.125%

EXAMINATIONS
- Examination time points: 0.5, 24, 48, 96 h and 7 days after patch removal 
- Grading/Scoring system: not described

Results and discussion

Results of examinations:

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.