1,3,5-Triazine-2,4,6-triamine, deammoniated

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

According to section 1 of REACH Regulation (EC) Annex XI, testing for sub-acute toxicity does not need to be conducted if testing does not appear scientifically necessary. For repeated-dose toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target organs in sufficient concentration to cause the toxic effect. This requires that the polymer molecules will have to be bioavailable by absorption via relevant routes of exposure. It is therefore unlikely to occur with this insoluble substance . Since the gut wall presents a substantial barrier to prevent uptake of high molecular weight substances, 1,3,5-Triazine-2,4,6-triamine, deammoniated is unlikly to cross the gastro-intestinal epithelium and to become systemically available for distribution to internal target tissues and organs. Considering the above mentioned factors, 1,3,5-Triazine-2,4,6-triamine, deammoniated is obviously devoid of toxicity via the oral route, i.e. sub-acute oral toxicity is no relevant toxicological endpoint. This applies also for any dermal exposure because permeation of a chemical through the Stratum corneum is basically a diffusion process in which active transport plays no role. The layer with the highest resistance to diffusion is the rate-limiting membrane. For many compounds,the lipophilic Stratum corneum is the primary or rate-limiting barrier. According to the so-called “Dalton rule” the molecular weight of a molecule may not exceed 500 Dalton (500 g/Mol) for a quantitative relevant skin penetration. The molecular weight of 1,3,5-Triazine-2,4,6-triamine, deammoniated is expected to be higher than 500 g/Mol (see mass spectrum and HPLC-analysis). In addition 1,3,5-Triazine-2,4,6-triamine, deammoniated is insoluble in water and not fat soluble, consequently it is not expected to be absorbed through the skin. Taking this into account, dermal absorption of 1,3,5-Triazine-2,4,6-triamine, deammoniated is not expected. The other appropriate route of exposure to 1,3,5-Triazine-2,4,6-triamine, deammoniated is the inhalative one which is also of no relevance due to the bio-inertness of the substance.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified