Registration Dossier
Registration Dossier
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EC number: 215-181-3 | CAS number: 1310-58-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to the SIDS document for potassium hydroxide (30 January 2002), a Klimisch score of 2 was assigned since test procedure is in accordance with national standard methods with acceptable restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute Toxicity of Cesium and Rubidium Compounds
- Author:
- Johnson GT et al
- Year:
- 1 975
- Bibliographic source:
- Toxicol. Appl. Pharmacol., 32, 239-245
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- repeated insult test : similar to test described by Landsteiner and Jacobs (1935)
the test substance was injected intracutaneously to separate skin sites of the animals (3x weekly, in total 9 threatments)
Two weeks after the last injection, a challenge dose (0.1ml) was administered (test and control animals).
Skin reactions were examined at 24, 48 and 72 hr following the challenge dose. - GLP compliance:
- no
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- LLNA method is not appropriate for strong corrosive substances.
Test material
- Reference substance name:
- Potassium hydroxide
- EC Number:
- 215-181-3
- EC Name:
- Potassium hydroxide
- Cas Number:
- 1310-58-3
- Molecular formula:
- HKO
- IUPAC Name:
- potassium hydroxide
- Details on test material:
- - Name of test material (as cited in study report): Potassium hydroxide
- Analytical purity: 85%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300-400 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intracutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- Route:
- other: intracutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 5
- Details on study design:
-
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 3 weeks
- Test groups: 5 males
- Control group: 10 males
- Frequency of applications: 3 times weekly
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Test groups: 5 males
- Control group: 10 males
- Concentrations: 0.1%
- Evaluation (hr after challenge): 24, 48 and 72h
OTHER: non-adjuvent study type - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- not sensitizing
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: not sensitizing.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- KOH (0.1%) does not induce cutaneous sensitization in guinea pigs
- Executive summary:
KOH (0.1%) does not induce cutaneous sensitization in guinea pigs
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