Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A study was identified as the key study (Gerbeix, 2010). In a dermal sensitization study performed according to the OECD test guideline No. 429 and in compliance with Good Laboratory Practice, cis-pentene-2-nitrile was tested in female CBA/J mice using the Local Lymph Node Assay.

 A preliminary test was first performed in order to define the concentrations of test item to be used in the main test.

In the main test, groups of four animals received Cis 2-Pentene Nitrile at the concentration of 5, 10, 25, 50 or 100% in a mixture acetone/olive oil (4/1; v/v) (vehicle). A negative and a positive control groups were included in the study.

The test item was soluble in the first recommended vehicle, acetone/olive oil (4/1, v/v).A solution was obtained at the maximum tested concentration of 50%. Consequently, the concentrations selected for the preliminary test were 10, 25, 50 and 100%. Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (100%).

 

No mortality related to treatment and no clinical signs were observed during the study.

No cutaneous reactions and no notable increase in ear thickness were observed in the animals of the treated groups.

A significant lymphoproliferation was noted in the positive control group given HCA at 25%, the study was therefore considered valid.

A significant lymphoproliferation (SI > 3) was noted at the concentration of 100% (SI = 4.43).

In the absence of local irritation, the significant lymphoproliferative response observed was attributed to delayed contact hypersensitivity.

The EC3value for the test item Cis 2-Pentene Nitrile is equal to 79%.

 

Under the experimental conditions of this study, the test item Cis 2-Pentene Nitrile induced delayed contact hypersensitivity in the murine Local Lymph Node Assay. According to the EC3 value obtained in this experiment, the test item Cis 2-Pentene Nitrile should be considered as a weak sensitizer.

 


Migrated from Short description of key information:
Skin sensitisation: weakly sensitising (kr 1, OECD 429, GLP)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available


Migrated from Short description of key information:
No data available

Justification for classification or non-classification

Cis-2 -pentene nitrile is classified as a skin sensitizer Category 1 (H317 May cause an allergic skin reaction) according to the CLP regulation (1272/2008) and Xi; R43 (May cause sensitisation by skin contact) according to the Directive 67/548/CEE.