Reaction products of amines, dicoco alkyl and glycollic acid

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Summary

The skin sensitization potential of the test substance was evaluated in three sequential studies. Review of the various lines of evidence and SCL of 9.4% has been determined for this substance.

Data Analyses

In order to evaluate the skin sensitization potential, a series of studies were conducted and briefly summarized in the following table, and the substance showed weak to moderate sensitizing effects under testing conditions.

 

	LLNA (^3H labelled)	LLNA (BrdU labelled)	LLNA (BrdU labelled)
Guidance	OECD429	OECD429	OECD429
Test Item	Test substance	Test substance	Test substance
GLP (Y/N)	Y	Y	Y
Year	2/27/2006	5/30/2006	5/30/2006
Species	CBA/Ca mice	CBA/J mice	CBA/J mice
# animals	5/group	5/group	5/group
Method	Dose levels: 100%, 50% and 25% in acetone/olive oil 4:1	Dose levels: 25%, 10%, 5%, 2.5% and 1% in acetone/olive oil 4:1	Dose levels: 100%, 50%, 25% and 10% in acetone/olive oil 4:1
Result	Stimulation Index Conc (%) SI 25% 2.34 50% 4.15 100% 4.40	Stimulation Index Conc (%) SI 1 1.3 2.5% 2.3 5% 1.0 10% 3.3 25% 8.5	Stimulation Index Conc (%) SI Ear thickness 10% 7.8 +25.0% 25% 11.6 +33.3% 50% 18.6 +76.2% 100% 14.4 +61.9%
	EC3 = 35% (calculated)	EC3 = 9.4%	All scores were above 3; unable to calculate EC3
Conclusion	·  Skin sensitizer ·  Reliable study (Klimich =1) ·  Supporting study	·  Skin sensitizer ·  Reliable study (Klimich =1) ·  Key study	·  Skin sensitizer, but severe local irritation effects were observed. ·  Unreliable study (Klimich = 3). ·  Discard study

Discussion

 Information on the potency of sensitization based on the LLNA test is available for this substance.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). Among the two reliable LLNA studies, the one with lower EC3 was assigned as the key study and the study result represents the “worst case value”. Therefore, a threshold for skin sensitization can be defined as the EC3 concentration of 9.4%.

  

References

 

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.

Migrated from Short description of key information:
The test material was positive for skin sensitisation in a key LLNA and one supporting LLNA study and one discarded LLNA study. A threshold for skin sensitization can be defined as the EC3 concentration of 9.4%.

Justification for classification or non-classification

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is required for skin sensitisation:

Category 1B, H317 may cause an allergic skin reaction.