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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited documentation and test procedure (e.g. low number of animals in study)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report date:
1966

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
NZW rabbits were dosed with 200 mg/kg bw sodium perborate tetrahydrate once daily over 20 days
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Sodium perborate tetrahydrate
IUPAC Name:
Sodium perborate tetrahydrate
Details on test material:
No further data available

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
No further data available

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on exposure:
The TS (2 mL/kg bw) was applied as 10 % aqueous solution to abraded skin. No further data available.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
20 days
Frequency of treatment:
Once daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0 or 200 mg/kg bw
Basis:
nominal per unit body weight
No. of animals per sex per dose:
3 m / 3 f
Control animals:
yes, concurrent vehicle
Details on study design:
No further data available
Positive control:
no

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes

CLINICAL OBSERVATIONS: Yes

DERMAL IRRITATION: Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION: no data

FOOD EFFICIENCY: no data

WATER CONSUMPTION: no data

OPHTHALMOSCOPIC EXAMINATION: no

HAEMATOLOGY: Yes (at termination)
RBC, WBC, Haemoglobin, Haematocrit, differential white cells

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
Sacrife on day 20.
Examinations: growth, organ/body weight ratios (liver, kidneys).
Microscopic examinations: adrenals, bladder, bone marrow, gonads, heart, intestine, kidney, liver, lung, lymph nodes, pancreas, spleen, stomach, thyroid, skin
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Dermal irritation:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
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.

Effect levels

Dose descriptor:
NOAEL
Effect level:
200 mg/kg bw/day (nominal)
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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

In this older and limited study, 3 m / 3 f 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.