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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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.
Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 300-400 g
Route:
other: intracutaneous
Vehicle:
water
Concentration / amount:
Concentrations used for induction: 0.1%
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

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.

No evidence of sensitisation in the study of Johnson GT et al.1975.The test substance (Potassium hydroxide as a surrogate for Potassium oxide) is not sensitising to skin.

 

Potassium Hydroxide (0.1%) does not induce cutaneous sensitization in guinea pigs. This result can be reliably be read across to the substance Potassium oxide l (CAS# 12136-45-7 )

 

Synopsis

Not sensitising

 

 

 

 


Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance Potassium oxide/Dipotassium oxide does not meet the criteria to be classified for human health hazards for Inhalation - local effect: skin sensitisation.

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation: in chemico
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Respiratory sensitisation.

There are no Respiratory sensitisationstudies available.

Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.

Potassium oxide is of low priority for further work based on a low hazard potential.is of low priority for further work based on a low hazard potential.

Synopsis

Not Sensitising


Migrated from Short description of key information:
There are no Respiratory sensitisation studies available.
Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.
Potassium oxide is of low priority for further work based on a low hazard potential.is of low priority for further work based on a low hazard potential.

Therefore testing for Respiratory sensitisation does not need to be performed.

Justification for classification or non-classification

Based on the hazard assessment of Potassium oxide/Dipotassium oxide section 2.1 and 2.2. in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Respiratory Sensitisation Xn

R42 May cause sensitization by inhalation

Respiratory Irritation Xi

R37 irritating to respiratory system

 

CLP

Respiratory Sensitisation

H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled

Respiratory Irritation

H335 STOT SE 3 May cause respiratory irritation

It is concluded that the substance Potassium oxide/Dipotassium oxide does notmeet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory sensitisation.