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

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

For reproductive toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target organs and tissues 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. reproductive 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.  

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

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 reproductive toxicity does not need to be conducted if testing does not appear scientifically necessary. For reproductive toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target organs and tissues 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. reproductive 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.

Reproductive effects observed:

not specified

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Justification for selection of Effect on fertility via oral route:

data waiving

Justification for selection of Effect on fertility via inhalation route:

not required

Justification for selection of Effect on fertility via dermal route:

not required

Effects on developmental toxicity

Description of key information

For developmental toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target organs and tissues 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. The toxicity threshold has to be reached before the maximum tolerated dose of the maternal animal prevents higher 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. developmental 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.

Link to relevant study records

Reference

Endpoint:

developmental toxicity

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 developmental toxicity does not need to be conducted if testing does not appear scientifically necessary. For developmental toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target organs and tissues 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. The toxicity threshold has to be reached before the maximum tolerated dose of the maternal animal prevents higher 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. developmental 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.

Abnormalities:

not specified

Developmental effects observed:

not specified

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Justification for selection of Effect on developmental toxicity: via oral route:

data waiving, see endpoint study record

Justification for selection of Effect on developmental toxicity: via inhalation route:

not required

Justification for selection of Effect on developmental toxicity: via dermal route:

not required

Justification for classification or non-classification

For reproductive and developmental toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target organs and tissues 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. The toxicity threshold has to be reached before the maximum tolerated dose of the maternal animal prevents higher 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. developmental 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.

Therefore the substance has not to be classified.