Perboric acid, sodium salt

Acute Toxicity: dermal

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

Test material information

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:

other: Clinical signs noted in survivors included diarrhoea, few faeces, yellow nasal discharge and soiling of the anogenital area.

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.