Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Introduction

A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.

Methods

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in butanone at concentrations of 100% or 10% or 1 % v/v. A further group of five animals was treated with butanone alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitizer, alpha-Hexylcinnamaldehyde tech., 85%, at a concentration of 15% v/v in butanone.

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

1% v/v of the test item in butanone gave negative results with a stimulation Index score of 1.55

10% v/v of the test item in butanone gave negative results with a stimulation Index score of 2.79

100% v/v of the test item gave positive results with a stimulation Index score of 10.01

25% v/v of the positive control in butanone gave positive results with a stimulation Index score of 8.23

Conclusion

The test item was considered to be a sensitiser under the conditions of the test and the concentration of test item expected to cause a 3 -fold increase in 3HTdR incorporation (EC3 value) was calculated to be 13 %. Alpha-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 when tested at a concentration of 15% v/v in butanone thus demonstrating the sensitivity and reliability of the test system.

Migrated from Short description of key information:

Klimisch Grade 1, GLP compliant LLNA study performed according to OECD 429.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for sensitisation according to the Regulation (EC) No. 1272/2008.

Self classification:

Based on the available data, additional classification for skin sensitisation is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).

SCL Justification

It is suggested that the LLNA EC3 value correlates relatively well with the NOEL from human sensitization tests designed to confirm lack of induction (Gerberick et al., 2001; Griem et al., 2003; Basketter et al., 2005).

 

• Basketter DA, Andersen KE, Liden C, Van Loveren H, Boman A, Kimber I, Alanko K, Berggren E (2005) Evaluation of the skin sensitizing potency of chemicals by using the existing methods and considerations of relevance for elicitation. Contact Dermatitis, 52: 39–43.
• Gerberick GF, Robinson MK, Ryan CA, Dearman RJ, Kimber I, Basketter DA, Wright ZM, Marks JG (2001) Contact allergenic potency: Correlation of human and local lymph node assay data. American Journal of Contact Dermatitis, 12: 156–161.
• Griem P, Goebel C, Scheffler H (2003) Proposal for a risk assessment methodology for skin sensitization based on sensitization potency data. Regulatory Toxicology and Pharmacology, 38: 269–290.