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Toxicological information

Acute Toxicity: oral

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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

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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 300 mg/kg bw
95% CL:
>= 850 - <= 1 990
Sex:
female
Dose descriptor:
LD50
Effect level:
890 mg/kg bw
95% CL:
>= 530 - <= 1 510
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:
>= 500 mg: diarrhoea
>= 1000 mg: hypoactivity, ataxia
Body weight:
No significant changes
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.