Registration Dossier
Registration Dossier
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EC number: 234-390-0 | CAS number: 11138-47-9
Repeated dose toxicity: dermal
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:
- 1 966
- 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
- Reference substance name:
- Sodium perborate tetrahydrate
- IUPAC Name:
- Sodium perborate tetrahydrate
- Details on test material:
- No further data available
Constituent 1
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.
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