Perboric acid, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium Perborate Monohydrate (Grade A)

IUPAC Name:

Sodium Perborate Monohydrate (Grade A)

Details on test material:

-Name of test material (as cited in study report): Sodium Perborate Monohydrate (Grade A)
-Physical state: White granules
-Lot/batch No.: No data
-Stability under test conditions: Sponsor assumed responsibility for purity and stability determinations
-Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Charles River Lab., Inc., Portage, MI
-Age at study initiation: young adult
-Weight at study initiation: 201-299 g
-Fasting period before study: overnight prior to dosing
-Housing: by sex in groups of 5
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21-25
-Humidity (%): 21-53

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
-Concentration in vehicle: 5, 10 and 20 % per mL
-Amount of vehicle: 10 mL/kg bw
-Justification for choice of vehicle: preparation of a uniform suspension

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Rationale for the selection of the starting dose:
A dose range finding was performed using one male and one female rat per dose (500, 1000, 2000 or 5000 mg/kg bw). Based on this results, an initial level of 1000 mg/kg bw and two additional dose levels of 500 and 2000 mg/kg bw were used.

Doses:

500, 1000 and 2000 mg/kg bw

No. of animals per sex per dose:

5 m / 5 f

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations and weighing: Definite study animals were observed for clinical signs and mortality at 1, 2.5, and 4 hours post-dosing. Thereafter all animals were observed for clinical signs daily and twice daily for mortalities.
-Necropsy of survivors and animals found dead performed: yes (gross)

Statistics:

Average body weights. The oral LD50 was calculated for each sex and for both sexes combined.
Method according to Thakur & Fezio (1981) Drug Chem Toxicol 4 (3), 297 - 305

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 300 mg/kg bw

95% CL:

>= 850 - <= 1 990

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

890 mg/kg bw

95% CL:

>= 530 - <= 1 510

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 120 mg/kg bw

95% CL:

>= 770 - <= 1 630

Mortality:

500 mg: 0/10
1000 mg: 1/5 m and 3/5 f died within 48 hrs after dosing
2000 mg: 5/5 m and 5/5 f died within 24 hrs after dosing

Clinical signs:

other: >= 500 mg: diarrhoea >= 1000 mg: hypoactivity, ataxia

Gross pathology:

500 mg: alopecia of entire inguinal region in 1 f (most likely coincidental)
1000 mg: enlarged renal pelvis in 1 f (most likely coincidental)
2000 mg: frequent findings located in the gastrointestinal tract (distended stomach with thickened walls, staining of glandular mucosa, entire GI tract filled with clear fluid) both in m and f

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute oral toxicity for Sodium Perborate Monohydrate was calculated to be 890 mg/kg for females, 1300 mg/kg for males and 1120 mg/kg for combined sexes.
According to OECD GHS, toxicity category IV (< 300 ≤ 2000) should be assigned.

Executive summary:

With Sodium Perborate Monohydrate an acute oral toxicity study was performed according to US-EPA Guideline OPP 81 -1. Five Sprague-Dawley rats per sex and group were dosed once via gavage with 500, 1000 and 2000 mg/kg bw. Animals were frequently monitored for clinical signs, body weight and mortality. All animals were examined for signs of macroscopic changes.

The acute oral LD50 was calculated to be 890 mg/kg for females, 1300 mg/kg for males and 1120 mg/kg for combined sexes. According to OECD GHS, toxicity category IV (< 300 ≤ 2000) should be assigned.