Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-hydrolyzed

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

The substance caused no adverse effects in a screening study for reproductive toxicity at 1000 mg/kg bw (BASF 2011b), as tested in a GLP compliant study following OECD testing guideline 421.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Species:

rat

Quality of whole database:

Screening level

Additional information

The substance was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg/day in a GLP compliant study following OECD testing guideline 421.

Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 42-50 days).

No parental toxicity was observed up to the highest dose level tested (1000 mg/kg). No treatment-related changes were noted in any of the parental parameters investigated in this study (i.e. clinical appearance, body weight, food consumption, macroscopic examination, organ weights, and microscopic examination).

No reproduction toxicity was observed up to the highest dose level tested (1000 mg/kg). No treatment-related changes were noted in any of the reproductive parameters investigated in this study (i.e. mating, fertility and conception indices, precoital time, and numbers of corpora lutea and implantation sites).

Effects on developmental toxicity

Description of key information

The substance caused no adverse effects in a screening study for developmental toxicity at 1000 mg/kg bw (BASF 2011b), as tested in a GLP compliant study following OECD testing guideline 421.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Species:

rat

Quality of whole database:

Screening level

Additional information

The substance was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg/day in a GLP compliant study following OECD testing guideline 421.

Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 42-50 days).

No parental toxicity was observed up to the highest dose level tested (1000 mg/kg). No treatment-related changes were noted in any of the parental parameters investigated in this study (i.e. clinical appearance, body weight, food consumption, macroscopic examination, organ weights, and microscopic examination).

No developmental toxicity was observed up to the highest dose level tested (1000 mg/kg). No toxicologically significant changes were noted in any of the developmental parameters investigated in this study (i.e. the gestation index and duration of gestation, parturition, maternal care and early postnatal pup development including mortality, clinical signs, body weight and macroscopy).

All available hazard data indicates that the pigment is not taken up by the body. Details are given in the toxicokinetic assessment. Therefore, further testing for developmental toxicity is not considered necessary.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available screening study is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008.