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Diss Factsheets

Administrative data

Description of key information

There is no evidence for a skin sensitising potential of Phosphoric acid, C12-18-alkyl esters, potassium salts from information of related read-across substance Phosphoric acid, dodecyl ester, potassium salt. 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to attached document
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
discrete/patchy erythema
Remarks on result:
positive indication of skin sensitisation
Remarks:
Positive control study performed from 2008-03-19 to 2008-04-25
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation
Remarks:
Positive control study performed from 2008-03-19 to 2008-04-25
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1 %
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Discrete/patchy to moderate/confluent erythema with or without scaling
Remarks on result:
positive indication of skin sensitisation
Remarks:
Positive control study performed from 2008-03-19 to 2008-04-25
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1 %
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Discrete/patchy to moderate/confluent erythema with or without scaling
Remarks on result:
positive indication of skin sensitisation
Remarks:
Positive control study performed from 2008-03-19 to 2008-04-25
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1 and 1 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation
Remarks:
Positive control study performed from 2008-03-19 to 2008-04-25
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1 and 1 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation
Remarks:
Positive control study performed from 2008-03-19 to 2008-04-25
Interpretation of results:
GHS criteria not met
Conclusions:
Available data from Phosphoric acid, dodecyl ester, potassium salt were used to evaluate the skin sensitising potential of Phosphoric acid, C12-18-alkyl esters, potassium salts.
Phosphoric acid, dodecyl ester, potassium salt does not need to be classified and labelled as a skin sensitizer, based on results of a guinea pig maximization test according to OECD guideline 406.
Taken together there is no evidence for a skin sensitising potential of Phosphoric acid, C12-18-alkyl esters, potassium salts from information of related read-across substance Phosphoric acid, dodecyl ester, potassium salt.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Available data from Phosphoric acid, dodecyl ester, potassium salt were used to evaluate the skin sensitising potential of Phosphoric acid, C12-18-alkyl esters, potassium salts.

 

Phosphoric acid, dodecyl ester, potassium salt does not need to be classified and labelled as a skin sensitizer, based on results of a guinea pig maximization test according to OECD guideline 406.In a dermal sensitisation study according to OECD TG 406, 1992) with Phosphoric acid, dodecyl ester, potassium salt, young adult Dunkin-Hartley guinea pigs were tested using the Maximization test method. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 1 % dilution of the test item in purified water in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 75 % in purified water one week after the intradermal induction. The animals of the control group were intradermally induced with purified water and FCA/physiological saline and epidermally induced with purified water under occlusion.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10 % in purified water and purified water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

No toxic signs were evident in the guinea pigs of the control or test group. No deaths occurred. No skin effect/reaction was observed in the control and test group after challenge treatment with the test item at 10 % in purified water.

Justification for read-across

Evaluation of structure-activity relationship is based on data from structural similar substances with the same basic structure, potassium salts of phosphoric acid alkyl ester, varying mainly in the chain length of fatty acid moiety. A detailed justification document for the read-across is attached in the respective target records of IUCID.

 

Taken together there is no evidence for a skin sensitising potential of Phosphoric acid, C12-18-alkyl esters, potassium salts from information of related read-across substance Phosphoric acid, dodecyl ester, potassium salt. 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on read-across data from a study according to OECD Guideline 406 on the read-across substance Phosphoric acid, dodecyl ester, potassium salt,of Phosphoric acid, C12-18-alkyl esters, potassium salts does not need to be classified as skin sensitizer according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).