Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

A 4-week oral toxicity study with sodium perborate tetrahydrate was performed as Limit test (one dose level of 1000 mg/kg bw/d) according to OECD Guideline 407. The test item induced changes in body weight and food consumption, laboratory parameters and induced histopathological changes in the spleen (reduced parenchyma) and had irritating effects to the mucous membrane of the stomach. Most of the functional changes were slight, within normal ranges and could be attributed to the histopathological changes. The target organs were identified as spleen and stomach. A re-examination of the testes was requested by the Sponsor due to the well-known testicular toxicity of sodium borate and boric acid. The histopathological examination confirmed the original findings, i.e. there was no testicular toxicity in males.

It was concluded that the NOAEL for males or females was slightly below 1000 mg/kg bw/d.


Short description of key information:
Effect level from a subchronic oral toxicity study with rats (OECD Guideline 407) (Zechel, 1989):
The NOAEL for sodium perborate tetrahydrate after daily oral dosing over 4 weeks with 1000 mg/kg bw was slightly below 1000 mg/kg bw/d. The treatment caused no adverse effects on reproductive organs and also sperm measures in parental males gave no adverse effects.

Effects on developmental toxicity

Description of key information
Effect levels from a Prenatal Developmental Toxicity Study (OECD Guideline 414) (Bussi, 1995):
NOAEL maternal toxicity: 100 mg sodium perborate tetrahydrate/kg bw/day
NOAEL fetotoxicity: 100 mg sodium perborate tetrahydrate/kg bw/day
Additional information

In a developmental toxicity study according to OECD Guideline 414, sodium perborate tetrahydrate was given by the oral route (gavage) to 25 pregnant rats from day 6 to day 15 of gestation at dosages of 0, 100, 300 and 1000 mg/kg bw/day. There were no clinical signs or behavioral changes and no deaths during the study. A statistically significant dose-related lower mean body weight gain and mean daily food consumption was observed in the >= 300 mg/kg bw/d groups, where a dose-related increase of resorptions and dose-related lower mean fetal and placental weight was also found. At 1000 mg/kg bw/d also an increase of malformations (mainly related to the skeletal and to the cardio-vascular system) was present.

At 100 mg/kg bw/d no biologically significant changes were found both in dams and foetuses.

Justification for classification or non-classification

Additional information