Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts

Endpoint summary

Description of key information

A Guinea pig maximisation test was carried out in group of 20 animals to determine skin sensitization potential caused by the chemicalDialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3). Each animals was treated with 5% of Dialkyl(C1-C14)dithiophosphoric acid, zinc salt in white mineral oil dermally and later observed for any signs of contact allergy. None of the guinea pig showed any signs of contact sensitization. Hence the chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3) was considered to be not sensitizing to the skin of guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment report

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

A Guinea pig maximisation test was carried out in group of 20 animals to determine skin sensitization potential caused by the chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No: 68649-42-3).

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 (IUPAC name): Dialkyl(C1-C14)dithiophosphoric acid, zinc salt
- Common name: Phosphorodithioic acid, O,O–di–C1–14–alkyl esters, zinc salts
- Molecular formula: C28H60O4P2S4Zn
- Molecular weight: 716.38 g/mol
- Smiles notation: [Zn+2].CCCCCCCOP(=S)([S-])OCCCCCCC.CCCCCCCOP(=S)([S-])OCCCCCCC
- InChl: 1S/2C14H31O2PS2.Zn/c2*1-3-5-7-9-11-13-15-17(18,19)16-14-12-10-8-6-4-2;/h2*3-14H2,1-2H3,(H,18,19);/q;;+2/p-2
- Substance type: Organic
- Physical state: liquid

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data available

Route:

intradermal and epicutaneous

Vehicle:

other: white mineral oil

Concentration / amount:

5%

Day(s)/duration:

No data available

Adequacy of induction:

not specified

Route:

epicutaneous, occlusive

Vehicle:

other: white mineral oil

Concentration / amount:

5%

Day(s)/duration:

No data available

Adequacy of challenge:

not specified

No. of animals per dose:

20

Details on study design:

No data available

Challenge controls:

No data available

Reading:

1st reading

Group:

test chemical

Dose level:

5%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No signs of sensitization were observed.

Remarks on result:

no indication of skin sensitisation

Cellular proliferation data / Observations:

No signs of sensitization were observed.

Interpretation of results:

other: not sensitizing

Conclusions:

The test material Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No: 68649-42-3) was considered to be not sensitizing to the skin of guinea pigs.

Executive summary:

A Guinea pigmaximisation test was carried out in group of 20 animals to determine skin sensitization potential caused by the chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3).

 

Each animals was treated with 5% of Dialkyl(C1-C14)dithiophosphoric acid, zinc salt in white mineral oil dermally and later observed for any signs of contact allergy.

 

None of the guinea pig showed any signs of contact sensitization. Hence the chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3) wasconsidered to be not sensitizing to theskin of guinea pigs.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization

Various studieshas been investigated for the test chemicalDialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No: 68649-42-3) to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No: 68649-42-3) and its structurally similar read across substancesCetrimonium chloride(CAS No:112-02-7) and Stearalkonium chloride (CAS No:122-19-0).The predicted data usingOECD QSAR toolboxdatabasethe has also been compared with the experimental data and summarized as below;

 

The EUROPEAN COMMISSION – European Chemicals Bureau (2000) conducted a Guinea pig maximisation test in 20 animals to determine skin sensitization potential caused by the chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3). Each animals was treated with 5% of Dialkyl(C1-C14)dithiophosphoric acid, zinc salt in white mineral oil dermally and later observed for any signs of contact allergy. None of the guinea pig showed any signs of contact sensitization. Hence the chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3) was considered to be not sensitizing to theskin of guinea pigs.

 

The skin sensitization potential of Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3) was estimated using OECD QSAR toolbox version 3.3 with log Pow as the primary descriptor. The substance Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3) was estimated to be not sensitizing to the skin of Dunkin-Hartley guinea pigs. Based on the estimated result, Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No:68649-42-3) failed to induce skin sanitization effects and hence is considered to be not sensitizing to Dunkin-Hartley guinea pigs.

 

The Cosmetic Ingredient Review (CIR) Expert Panel (1997) carried outa Repeated Insult Patch Testin 114 volunteers to assess the skin sensitization potential ofstructurally similar read across substance Cetrimonium chloride(CAS No:112-02-7) under occlusive condition. During induction, each subject received 0.3ml of 0.25%Cetrimonium chloride on upper arm for 24 hours on Monday, Wednesday and Friday for 3 weeks.After rest period of 17 days, volunteers were challenged on previously untreated sites at same concentration used in induction [0.25% (0.3mL)].Volunteers showed only mild irritation but nosigns of sensitization were observed. Hence the chemical Cetrimonium chloride(CAS No:112-02-7) was considered to be not sensitizing to the skin of 114 volunteers.

 

 

The above results were further supported by the experimental study conducted by Cosmetic Ingredient Review (CIR) Expert Panel(1990) ofstructurally similar read across substanceStearalkonium chloride (CAS No:122-19-0) on 50 volunteers via repeated insult patch test.Fifty volunteers were treated with a 1% solution in water for 15 applications and then given a challenge application. Zero readings were obtained for all subjects, for all induction applications, and for the challenge dose. Therefore,Stearalkonium chloride (CAS No:122-19-0) wasconsidered to be not sensitizing to thehuman skinin aRepeated Insult Patch Test.

 

Based on the available data for the target chemical, supporting studies and read across substance,it can be concluded thatchemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No: 68649-42-3)is unable to cause skin sensitization and considered as not sensitizing .Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No: 68649-42-3)and its structurally similar read across substancesCetrimonium chloride(CAS No:112-02-7) and Stearalkonium chloride (CAS No:122-19-0) were observed in various studies. From the results obtained from these studies it is concluded that the chemical Dialkyl(C1-C14)dithiophosphoric acid, zinc salt (CAS No: 68649-42-3)is not likely to cause skin sensitization and hence can be classified as non skin sensitizer.