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Description of key information

The skin sensitizing potential for Potassium acid phthalate (CASno-877-24-7) is estimated using OECD QSAR toolbox version 3.4. The test substance is estimated to be not sensitizing in guinea pig.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
Justification for type of information:
Data is from QSAR toolbox version 3.4.
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.4.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
Name of test material (as cited in study report): Potassium hydrogen phthalate
- Molecular formula: C8H5O4K
- Molecular weight (if other than submission substance): 204.23 g/mole
-InChI: 1S/C8H6O4.K/c9-7(10)5-3-1-2-4-6(5)8(11)12;/h1-4H,(H,9,10)(H,11,12);/q;+1/p-1
-Smiles: c1(c(cccc1)C(=O)[O-])C(O)=O.[K+]
-Substance Type: Organic
-Physical State: Solid
Details on the study design:
No data
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
not specified
Day(s)/duration:
not specified
Adequacy of induction:
not specified
No. of animals per dose:
not specified
Details on study design:
not specified
Challenge controls:
not specified
Positive control substance(s):
not specified
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not sensitizing
Remarks on result:
no indication of skin sensitisation
Variability:
not specified
Test group / Remarks:
not specified
Remarks on result:
not measured/tested
Interpretation of results:
other: Not sensitizing
Conclusions:
The substance Potassium acid phthalate is estimated to be not sensitizing in guinea pig.
Executive summary:

The skin sensitizing potential for Potassium acid phthalate is estimated using OECD QSAR toolbox version 3.4.

The test substance is estimated to be not sensitizing in guinea pig.

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

Skin sensitization

Various studies for target (Potassium acid phthalate, CASno-877-24-7) and its read across were summarized as follows:

The skin sensitizing potential for Potassium acid phthalate (CASno-877-24-7) is estimated using OECD QSAR toolbox version 3.4. The test substance is estimated to be not sensitizing in guinea pig.

In other study by (SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS – SCCP, 2005) with similar substance (65-85-0)was observed in Human. A Human maximization test was observed for Benzoic acid in 25 human volunteers. When 2% concentration of human volunteers in petrolatum was applied as patch tests for five times in 48 hour over a period of 10 days in 25 human volunteers. When challenged 10-14 d after the induction phase with a final 48 h closed patch test with 2 % benzoic acid in petrolatum. No sensitization was observed in any 25 human volunteers. Therefore Benzoic acid was considered to be non sensitizing in human and cannot be classified as skin sensitizer.

In another study by (Bruce g. hammond, George j. levinskas, Ellen c. robinson, 1987)with similar substance (85-68-7)was observed in human. A skin sensitization test was conducted for Butyl benzyl phthalate (BBP) in 200 human volunteers for 24 hrs. Patches containing undiluted BBP were applied to the skin of 200 human volunteers for 24 hrs, 3 times a week for 5 weeks. After a 2-week rest period when no patches were applied, human test subjects were rechallenged by applying patches containing BBP for 24 hours at previously untreated sites on the skinDuring the induction and challenge phases, application sites were examined for signs of sensitization. No sign of sensitization was observed in any 200 human volunteers after 15 daily applications of a subsequent challenge with BBP. Therefore BBP was not considered to be a skin sensitizer in human repeated insult patch tests.

On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance can be considered as not sensitising to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Basis of available information for the target Potassium acid phthalate(CAS no-93-18-5) as well as read across andapplying weight of evidence approach, the test substance can be considered as not sensitising to the skin.