Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:
melam
IUPAC Name:
melam

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

No toxicity at all was detected in the repeated dose oral toxicity study at high doses. The toxicity result and the NOAEL for the oral route are also adopted for the dermal route as it is generally accepted that the dermal NOAEL is higher than the oral one and using the same NOAEL also for the dermal situation is a worst case assumption, see Guidance Document on Information Requirements Chapter R.8.4.2. The exposure of humans will be low, as the conditions during manufacturing will prevent an exposure. Melam is exclusively introduced into plastic material during compounding. It is included by this process into a matrix and is no longer available for dermal exposure. It is concluded that no toxicity will be revealed in the dermal study too, especially at low exposures as it is expected for humans.

The following argumentations were taken from the paper "Maximum expected exposure levels in workers and the general population" of T. Tiemersma and Wil ten Berge of DSM Regulatory Affairs & Product Safety Polymers, 6 July 2010, report Tox. 31490a. "Melam is a solid. ... The exposure of consumers should be related to the end use of melam. Melam is used for electronic components in Personal Computers, Televisions, Laptops etc. There is no direct contact by hands touching the components."