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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: Published data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
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. When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide.

Data source

Reference
Reference Type:
publication
Title:
Acute Toxicity of Cesium and Rubidium Compounds
Author:
Johnson GT et al
Year:
1975
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:
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: compact
Details on test material:
- Name of test material (as cited in study report):Potassium Hydroxide- Analytical purity: 85%Potassium Hydroxide is used in the manufacturing process for Potassium amyl xanthate and is present in the final product. Therefore, the health effects of Potassium Hydroxide need to be considered in the assessment of potassium amyl xanthate.

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:
Concentrations used for induction: 0.1%
Challengeopen allclose all
Route:
other: intracutaneous
Vehicle:
water
Concentration / amount:
Concentrations used for induction: 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 group
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:
other: not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Potassium Hydroxide (0.1%) does not induce cutaneous sensitization in guinea pigs
When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide.
Executive summary:

Potassium Hydroxide (0.1%) does not induce cutaneous sensitization in guinea pigs

When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide.