Methyltrioctylammonium chloride

Endpoint summary

Description of key information

Skin Sensitization:

A prophetic patch test on humans of wool fabric impregnated with the 0.5%(w/w) of the test chemical,  produced no evidence of irritation or sensitization.

Hence, Methyl(trioctyl)azanium chloride can be considered to be not sensitizing to human skin.       

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin Sensitization:

In different studies,Methyl(trioctyl)azanium chloridehas been investigated for potential for dermal sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs, humans for the target chemical as well its structurally similar chemicals.

Prophetic patch tests were conducted to determine the allergenic potential of the test chemical. Methyl(trioctyl)azanium chloride impregnated in wool fabric(1 inch square) a 0.5% (w/w) concentration and untreated wool fabric (1 inch square) was applied to the intact skin of left arm of 31 human volunteers for 48 hours.

After 2 weeks of rest period, the humans were sensitized with the same dose to approximately same area of the skin for 48 hours.

A prophetic patch test on humans of wool fabric impregnated with the 0.5%(w/w) of the test chemical,  produced no evidence of irritation or sensitization. Hence, Methyl(trioctyl)azanium chloride can be considered to be not sensitizing to human skin.       

This is supported by the results of the dermal sensitization study carried out in guinea pigs to determine the allergic potential of Methyl(trioctyl)azanium chloride. A total of 30 male guinea pigs were used for the study.10 test guinea pigs, 10 positive control guinea pigs; 10 control guinea pigs - 5 receiving challenge dose of test compound without prior sensitizing dose, 5 receiving challenge dose of positive control [DNCB] without prior sensitizing dose. DNCB was used as the positive control substance.

Guinea pigs were given intradermal injections of 0.1 ml of 0.1% suspensions of test compound or positive control in a mixture containing 1 volume of propylene glycol and 19 volumes of saline.

The challenge dose of DNCB in the positive control guinea pigs caused a greater skin response 24 and 48 hours after injection than the initial sensitizing dose. However, the response to the DNCB challenge dose was three times more intense than the response to the test chemical challenge dose. The response of the 5 control guinea pigs receiving the challenge dose without prior sensitization was of the same intensity as that obtained from the initial intradermal dose in the positive control group.

The initial intradermal sensitizing dose of the test chemical caused inflammatory responses in guinea pigs 24 and 48 hours after the intradermal injection. The challenge dose (last intradermal injection) of the test chemical caused greater skin response in than the initial sensitizing dose in test guinea pigs at 24 and 48 hours after injection.

The response of 5 control guinea pigs receiving the challenge dose of the test chemical without prior sensitizing doses was greater than the response from the initial intradermal dose of the test chemical but was of the same intensity as that of the control guinea pigs receiving the test chemical.

The observations for sensitization potential of Methyl(trioctyl)azanium chloride gave equivocal results.

The above results are supported by Buehler test conducted to determine the allergic potential of the structurally similar chemical. The study was performed according to OECD 406 Guidelines. Irritation to the skin was seen following challenge with 1% test material but no indication of any sensitization. Hence, the test chemical was considered to be not sensitizing to guinea pig's skin.

These results are further supported by a Human repeated insult patch test (HRIPT) carried out to evaluate the dermal sensitization potential of the structurally similar chemical. 2% solution of the test chemical was freshly prepared daily. The test chemical when tested on human volunteers by Human repeated insult patch test (HRIPT) using 2% concentration produced no skin allergic reactions. Hence, it was considered to be not sensitizing to skin.

Even though the results of the guinea pig study for the target chemical gave an equivocal result but results of patch test in humans using the target chemical along with the available data for thestructurally similar read across chemicalslend support to the claim that Methyl(trioctyl)azanium chloride can indeed be not sensitizing to skin. Hence, Methyl(trioctyl)azanium chloride can be considered to be not sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Available data for Methyl(trioctyl)azanium chloride indicates that it is likely to not likely to cause any dermal sensitization. Hence, Methyl(trioctyl)azanium chloride can be considered to be not sensitizer to skin.