Registration Dossier

Administrative data

Description of key information

oral LD50 (rat; m/f): 1120 mg/kg bw (key study: Glaza, 1988)
inhalation LC50 (4 hrs; rat; m): ca. 1165 mg/m3 (key study: Valentine, 1987)
dermal LD50 (NZW rabbit; m/f): > 2000 mg/kg bw (key study: Cerven, 1987)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 120 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
1 165 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral toxicity

Several studies according to recent guidelines with GLP compliance have been performed with sodium perborate monohydrate as well as with sodium perborate tetrahydrate.

Results for sodium perborate monohydrate:

LD50 (rat): 1120 mg/kg bw (Glaza, 1988)

LD50 (rat): 1800 mg/kg bw (Cerven, 1987)

LD50 (rat): > 650 mg/kg bw (Mulinos et al., 1952)

Results for sodium perborate tetrahydrate:

LD50 (rat): 2567 mg/kg bw (Mayr, 1987)

LD50 (rat): 2440 mg/kg bw (Gillissen, 1966)

LD50 (mouse): 2730 mg/kg bw (Gillissen, 1966)

LD50 (mouse): > 1200 mg/kg bw (Weaver, 1965)

LD50 (mouse): 2800 mg/kg bw (Unilever, 1966)

Toxic signs were unspecific and included diarrhoea, ataxia, prostration, staining of the anogenital area, redness and bleeding into stomach and intestines (gas filled).

Dermal toxicity

Sodium perborate monohydrate was tested in a guideline study with GLP compliance NZW rabbits. The LD50 was given with > 2000 mg/kg bw. Clinical signs noted in survivors included diarrhoea, few faeces, yellow nasal discharge and soiling of the anogenital area. Gross pathology showed no adverse necropsy findings in 7/9 survivors. Treated skin and intestinal abnormalities were noted in the remaining animals. Necropsy results of the died male revealed abnormalities of the lung, liver, spleen and gastrointestinal tract, a yellow staining of the nose/mouth and brown staining of the anogenital area.

Inhalation toxicity

Sodium perborate tetrahydrate was tested in a guideline study with GLP compliance in male rats (Valentine, 1987). The calculated LC50 value (4 h) was given with 1165 mg/m3. During or immediately following exposure, rats from all groups exhibited gasping, red nasal discharge, and compound-covered faeces. In some survivors red ocular, nasal or oral discharge, diarrhoea, gasping, and lung noise was noted.

Justification for classification or non-classification