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EC number: 942-445-1 | CAS number: -
- slight necrosis following intradermal injection of 100% or 50% test substance in olive oil
- no necrosis at 25% or lower
- 25% was the MNNC and used for intradermal induction in the main test
- slight erythema present 24 hr after exposure to 100% or 50% test substance in liquid paraffin
- no erythema at 25% or lower
- 25% was the Pre-MNIC and used for epicutaneous induction
- 25% selected as the starting point for determination of the MNIC
- no dermal reactions present at 24 hr
- 25% test substance in liquid paraffin was the MNIC
- 25% and 12.5% were selected as the challenge concentrations
- Control group
- no cutaneous reactions present after intradermal or epicutaneous treatment
- Test group
- no cutaneous reactions recorded after intradermal induction
- dryness (4/20 animals) and eschar (9/20 animals) present 24 hr after epicutaneous induction.
- no cutaneous reactions at any time point (24, 48 or 72 hr)
- slight or moderate erythema in 3/20 animals at 24 hr post-challenge with 25% test substance
- slight erythema in 1/20 animals at 48 hr post-challenge with 25% test substance
- no dermal responses in any animal 72 hr following challenge with 25% test substance
- no dermal responses in any animal at 24 hr, 48 hr or 72 hr after challenge with 12.5% test substance
- negative control animals gained 159.5 g (SD = 30.7) over the course of the study
- test animals gained 150.6 g (SD = 23.4 ) over the same period
The dermal sensitisation potential of NExBTL renewable diesel was assessed in a GLP-compliant guideline guinea pig maximisation test (skin sensitisation, method B6 of directive 96/54/EC) using 10 control animals and 20 test animals. Based on results of preliminary testing, concentrations of 25% in olive oil (intradermal injection) and 100% (epicutaneous, under occlusion) were administered during the induction phase (study days 0 and 7, respectively) with 12.5% and 25% in liquid paraffin (epicutaneous, under occlusion) used for challenge on study day 20. Dermal responses (erythema, oedema) were recorded at 24, 48 and 72 hr post-challenge. Alpha-hexylcinnamaldehyde (aHCA; n=10 animals) was used as positive control substance. No dermal reactions were present in the negative controls following challenge with NExBTL renewable diesel, however slight or moderate erythema was present in 3/20 animals 24 hr after challenge with 25%, with slight erythema remaining in 1/20 animals at the 48 hr time point. These reactions were fully resolved by 72 hr. No erythema or oedema was in any test animal challenged with 12.5% test substance. A satisfactory response was obtained with the positive control group (100% sensitisation at 50% aHCA; 50-100% with 25%). Both the control (+159.5 g; SD = 30.7) and test groups (150.6 g; SD = 23.4) gained weight over the course of the study. The results demonstrate that NExBTL renewable diesel is not a skin sensitiser.
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