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Administrative data

Description of key information

Reliable studies are available for oral application as well as for dermal application.
Oral (Zechel, 1989):
Study design according to OECD Guideline No. 407
NOAEL: < 1000 mg/kg bw (only one dose tested)
Dermal (King, 1966):
Study design: no Guideline followed
NOAEL: 200 mg/kg bw

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
LOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subchronic
Species:
rabbit

Additional information

Oral:

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 in rats. 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.

Dermal:

In an older and limited study, NZW rabbits were dosed with 200 mg/kg bw sodium perborate tetrahydrate once daily over 20 days. One animal from each group died (cause of death was not determined). The only notable gross observation at necropsy was indication of parasites in individual animals and gastritis and enteritis. The skin was near normal (in some cases signs of mild irritation) and there were no adverse microscopic findings in different organs.

From this limited study a NOAEL of 200 mg/kg bw can be derived.


Repeated dose toxicity: dermal - systemic effects (target organ) cardiovascular / hematological: spleen; digestive: stomach

Justification for classification or non-classification

Based on the current findings there is no indication of a specific target organ with relevance to human health.