Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Sodium Perborate Monohydrate
IUPAC Name:
Sodium Perborate Monohydrate
Details on test material:
-Purity: no data
-Physical state: White granules
-Lot/batch No.: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Ace Animals
-Age at study initiation: no data
-Weight (at pretest): m: 2 - 2.6 kg; f: 2.3 - 2.6 kg
-Fasting period before study: no
-Housing: one animal per cage in supended wire mesh cages
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
-Area of exposure: dorsal
-% coverage: 10
-Type of wrap: gauze patch wrapped with plastic secured with non-irritating tape

REMOVAL OF TEST SUBSTANCE
-Washing: yes, with water
-Time after start of exposure: 24 hrs

TEST MATERIAL
-Amount(s) applied: 2000 mg/kg bw (test substance was moistened with water)
Duration of exposure:
24 hours
Doses:
Single dosing with 2000 mg/kg bw
No. of animals per sex per dose:
5 m / 5 f
Control animals:
not required
Details on study design:
-Duration of observation period following administration: 14 days
-Frequency of observations and weighing: All animals were observed 1, 2 and 4 hours post dose and twice daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded pre-test, weekly, at death and at termination.
-Necropsy of survivors and pre-terminal deaths performed: yes
Statistics:
Not further specied

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One male died on day 13 with pre-death clinical signs of diarrhoea, few faces, yellow nasal discharge and soiling of the anogenital area.
Clinical signs:
Clinical signs noted in survivors included diarrhoea, few faeces, yellow nasal discharge and soiling of the anogenital area.
Body weight:
No significant changes in survivors.
Gross pathology:
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.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The acute dermal LD50 in rabbits was > 2000 mg/kg bw
Executive summary:

In an acute dermal toxicity study according to OECD 402, 5 male and 5 female rabbits received Sodium Perborate Monohydrate to a clipped area of the intact skin for 24 hours. The post-observation period was 14 days. 9/10 animals survived.

It is therefore concluded that the dermal toxicity (LD50) in rabbits is >2000 mg/kg bw.