Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: written assessment
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A written assessment of toxicokinetic behaviour is considered appropriate for the substance.

Data source

Materials and methods

Test material

1
Chemical structure
Reference substance name:
-
EC Number:
437-450-6
EC Name:
-
Cas Number:
64654-05-3
Molecular formula:
Hill formula: C28 H37 N
IUPAC Name:
N-(dodecylphenyl)naphthalen-1-amine
Test material form:
liquid: viscous
Details on test material:
Sponsor's identification: APAN
Description: redbrown viscous liquid
Lot number: EL01010B01/KZ8911.5
Storage conditions: room temperature in the dark

Results and discussion

Applicant's summary and conclusion

Conclusions:
In conclusion, there is no evidence that would suggest that C10-13 Branched alkyl-N-(naphthyl) aniline absorbed via the dermal route and the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. The substance is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues the substance may then accumulate in individuals that are frequently exposed to that substance. However once exposure stops, the concentration within the body will decline at a rate determined by the half-life of the substance. Metabolism prior to absorption may occur by gut microflora or enzymes in the GI mucosa. Since substances that enter the blood at this point pass through the liver before entering the systemic circulation, hepatic first pass metabolism may limit the amount of parent compound that enters the systemic circulation. The substance would then be expected to be excreted in the faeces alongside the metabolites of N-1-naphthylaniline, glucuronide and sulphites.
Based on the physicochemical properties of the substance low bioaccumulation would be expected. 
Executive summary:

In conclusion, there is no evidence that would suggest that C10-13 Branched alkyl-N-(naphthyl) aniline absorbed via the dermal route and the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. The substance is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues the substance may then accumulate in individuals that are frequently exposed to that substance. However once exposure stops, the concentration within the body will decline at a rate determined by the half-life of the substance. Metabolism prior to absorption may occur by gut microflora or enzymes in the GI mucosa. Since substances that enter the blood at this point pass through the liver before entering the systemic circulation, hepatic first pass metabolism may limit the amount of parent compound that enters the systemic circulation. The substance would then be expected to be excreted in the faeces alongside the metabolites of N-1-naphthylaniline, glucuronide and sulphites.

Based on the physicochemical properties of the substance low bioaccumulation would be expected.