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Administrative data

Description of key information

Skin Irritation:

The dermal irritation potential of Potassium hydrogen phthalate was estimated using OECD QSAR toolbox v3.4

Potassium hydrogen phthalate was estimated to be not irritating to the skin of New Zealand White rabbits.

Eye Irritation:

The ocular irritation potential of Potassium hydrogen phthalate was estimated using OECD QSAR toolbox v3.4.

Potassium hydrogen phthalate was estimated to be not irritating to the eyes of New Zealand White rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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 OECD QSAR toolbox v3.4 and the QMRF report has been attached
Qualifier:
equivalent or similar to guideline
Guideline:
other: predicted data
Principles of method if other than guideline:
Prediction was done using OECD QSAR toolbox v3.4
GLP compliance:
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data available
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no irritation/corrosive effects were observed
Interpretation of results:
other: not irritating
Conclusions:
Potassium hydrogen phthalate was estimated to be not irritating to the skin of New Zealand White rabbits.
Executive summary:

The dermal irritation potential of Potassium hydrogen phthalate was estimated using OECD QSAR toolbox v3.4

Potassium hydrogen phthalate was estimated to be not irritating to the skin of New Zealand White rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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 OECD QSAR toolbox v3.4 and the QMRF report has been attached
Qualifier:
equivalent or similar to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Prediction was done using OECD QSAR toolbox v 3.4
GLP compliance:
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data available
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
75 mg
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
1
Details on study design:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Interpretation of results:
other: not irritating
Conclusions:
Potassium hydrogen phthalate was estimated to be not irritating to the eyes of New Zealand White rabbits.
Executive summary:

The ocular irritation potential of Potassium hydrogen phthalate was estimated using OECD QSAR toolbox v3.4.

Potassium hydrogen phthalate was estimated to be not irritating to the eyes of New Zealand White rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Various studies for target as well as its read across were summarized as follows:

The dermal irritation potential of Potassium hydrogen phthalate was estimated using OECD QSAR toolbox v3.4

Potassium hydrogen phthalate was estimated to be not irritating to the skin of New Zealand White rabbits.

The dermal irritation potential of the similar substance 65-85-0 (Benzoic acid) was evaluated (Scientific Committee on Consumer Products- SCCP Opinion on Benzoic Acid and Sodium Benzoate, Adopted by the SCCP during the 4th plenary of 21 June 2005) according to OECD 404 (1981), EEC test method B.4, Annex V of EEC Directive 84/449/EEC (September 1984).

A paste, (0.5 g benzoic acid and 0.25 ml water), was applied evenly to 6 cm2 Metalline on a permeable tape (Micropore). This was applied to the right flank of 3 females New Zealand albino rabbits. A control patch without the test substance was applied to the left flank. These were left in place for 4 hours. The test site was cleaned first with a dry tissue and then by swabbed with a dampened tissue. The skin was examined for erythema, eschar formation and oedema at 1, 24, 48 and 72 hours after removal of the patches. Two animals showed slight erythema initially. 1 of these also showed slight edema up to 24 h. These effects were resolved by 48 h. There was no indication of a systemic effect. The modified primary irritation index (PII) of 0.5 was recorded when benzoic acid was applied to the intact rabbit skin under semi-occlusive patch conditions.

Based on the scores, Benzoic acid can be considered to be not irritating to New Zealand albino rabbit skin.

The dermal irritation potential of the similar substance 532-32-1 (Sodium benzoate) was evaluated (Scientific Committee on Consumer Products- SCCP Opinion on Benzoic Acid and Sodium Benzoate, Adopted by the SCCP during the 4th plenary of 21 June 2005) according to OECD 404 (1981), EEC test method B.4, Annex V of EEC Directive 84/449/EEC (September 1984).

Approximately 24 hours prior to the treatment, the dorsal fur was shaved. A paste, (0.5 g sodium benzoate and 0.25 ml water), was applied evenly to 6 cm² Metalline on a permeable tape (Micropore). The 6 cm² patch was removed four hours after semi-occlusive contact. The skin reactions were assessed approx. 1 hour, 24, 48 and 72 hours after termination of the exposure. The animals did not show any symptoms of systemic intoxication.

Under the conditions of the study, sodium benzoate was neither corrosive nor irritating (PII 0) when applied to the intact rabbit skin under semi-occlusive patch conditions for four hours.

Sodium benzoate can be considered as not irritating to New Zealand albino rabbit skin.

 

Based on the information available for target as well as it read across chemicals, and applying the weight of evidence approach,Potassium hydrogen phthalatecan be considered as not irritating to skin.

 

Eye Irritation

Various studies for target as well as its read across were summarized as follows:

The ocular irritation potential of Potassium hydrogen phthalate was estimated using OECD QSAR toolbox v3.4.

Potassium hydrogen phthalate was estimated to be not irritating to the eyes of New Zealand White rabbits.

The ocular irritation potential of the similar substance 532-32-1 (Sodium benzoate) was evaluated (GESTIS, 2017) in humans. Sodium benzoate was instilled into human eyes and effects were observed (dose and duration not specified).

Under the conditions of the study, sodium benzoate was not irritating to human eyes.

Another study was conducted (SIDS Initial Assessment Report for 13th SIAM - Benzoates, 2001) in rabbits to evaluate the ocular irritation potential of the similar substance 532-32-1 (Sodium benzoate). The study was performed according to the Directive 84/449/EEC. Sodium benzoate was instilled into rabbit eyes and effects were observed (duration and dose not specified).

Under the conditions of the study, sodium benzoate was not irritating to rabbit eyes.

The ocular irritation potential of the similar substance 85-68-7 (Benzyl butyl phthalate) was evaluated (International Journal of Toxicology, Vol 11, Issue 1, pp. 1 – 23, 1992) in 6 New Zealand White rabbits.0.1ml of undiluted Benzyl butyl phthalate was instilled into the conjunctival sac of the eyes of the 6 rabbits and effects were observed till 48 hours. Under the conditions of the study, benzyl butyl phthalate showed slight irritation in rabbit eyes which subsided completely before 48 hours.

Hence, Benzyl butyl phthalate can be considered as not irritating to New Zealand White rabbit eyes.

Based on the information available for target as well as it read across chemicals, and applying the weight of evidence approach,Potassium hydrogen phthalatecan be considered as not irritating to eyes.

Justification for classification or non-classification

Available studies forPotassium hydrogen phthalateindicates that it is not likely to cause any irritation to skin and eyes.

Hence,Potassium hydrogen phthalate can be evaluated as “Non - Irritant” to eyes and skin and it can be classified under the category “Not Classified” as per CLP regulation.