Disodium octaborate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FIFRA (40 CFR)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium octaborate

EC Number:

234-541-0

EC Name:

Disodium octaborate

Cas Number:

12008-41-2

Molecular formula:

Na2B8O13

IUPAC Name:

disodium bis[(oxoboranyl)oxy]bicyclo[5.5.1]hexaboroxane-3,5-bis(olate)

Details on test material:

- Name of test material: 20 MULE TEAM TIM-BOR
- Physical state: White powder
- Analytical purity: > 98 %
- Lot/batch No.: 8E25H
- Stability under test conditions: Stable

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Approved USDA source
- Weight at study initiation: Males 262 –371g; Females 226 –275 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 % w/v

Doses:

1.25; 2.0; 3.15; 5.0 g/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: No data
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs and body weight

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 550 mg/kg bw

95% CL:

>= 2.1 - <= 3.1

Remarks on result:

other: According to the method of Litchfield and Wilcoxon

Mortality:

At 5.0 g/kg ten deaths occurred between days 0 and 2 of the observation period.
At 3.15 g/kg six deaths occurred between days 1 and 3 of the observation period.
At 2.0 g/kg four deaths occurred on day 1 of the observation period.
At 1.25 g/kg there were no deaths.

Clinical signs:

other: At 5.0 g/kg the following clinical changes were observed: Mild to extreme depression, fecal stains, loose mucoid faeces on cage paper, urine stains, piloerection, eye squinting and scruffy hair coats. At 3.15 g/kg the following clinical changes were obser

Gross pathology:

Pathological changes in the animals that died included darkened, reddened pale and/or mottled lungs; congested, mottled or pale kidneys, mottled and/or pale liver and spleens; pale intestines filled with clear yellow liquid; pale pancreas and green watery fluid in stomach and partially distended stomach which reduced in severity with reducing dose

Any other information on results incl. tables

Cumulative mortality data for male and female rats treated orally with 20 MULE TEAM TIM-BOR:

Dosage (g/kg)	Cumulative No. of deaths^a
	Observations^b			Observations day after treatment
	A	B	C	1	2	3	4	7	14
Males
5.0	0	0	0	3	5	5	5	5	5
3.15	0	0	0	1	2	4	4	4	4
2.0	0	0	0	2	2	2	2	2	2
1.25	0	0	0	0	0	0	0	0	0
Females
5.0	0	0	2	5	5	5	5	5	5
3.15	0	0	0	2	2	2	2	2	2
2.0	0	0	0	2	2	2	2	2	2
1.25	0	0	0	0	0	0	0	0	0

^a Five animals per dose per group.

^b A = 1 3/4 - 2 h; B = 3 1/4 - 5 3/4 h; C = 6 - 6 3/4 h.

Body weight gain in male and female rats terated orally with 20 MULE TEAM TIM-BOR:

Animal No.	Sex	Body weight gain (g) Day 0 - 14
0.5 g/kg group
1-7675	M	ND
2-7686	M	ND
3-7700	M	ND
4-*	M	ND
5-*	M	ND
6-7734	F	ND
7-7737	F	ND
8-7753	F	ND
9-7763	F	ND
10-*	F	ND
3.15 g/kg group
1-7683	M	ND
2-7688	M	ND
3-*	M	69
4-*	M	ND
5-*	M	ND
Mean (S.D.)		69
6-7730	F	74
7-7736	F	21
8-7744	F	ND
9-4449	F	38
10-*	F	ND
Mean (S.D.)		44 (27)
2.0 g/kg group
1-7695	M	48
2-*	M	89
3-*	M	ND
4-*-	M	101
5-*	M	ND
Mean (S.D.)		79 (28)
6-7741	F	43
7-7751-D	F	ND
8-7752	F	54
9-*	F	ND
10-*	F	39
Mean (S.D.)		45 (8)
1.25 g/kg group
1-7684	M	78
2-*	M	125
3-*	M	85
4-*	M	82
5-*	M	82
Mean (S.D.)		90 (20)
6-7729	F	34
7-7756	F	55
8-*	F	47
9-*	F	45
10-*	F	40
Mean (S.D.)		44 (8)

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

The acute oral LD50 for males and females was 2550 mg/kg bw.

Executive summary:

The test item disodium octaborate tetrahydrate was assessed for oral acute toxicity in rats in a GLP study according to OECD Guideline 401. Five animals per sex per dose were exposed via gavage to doses of the test item (50% in water) of 1.25; 2.0; 3.15 and 5.0 g/kg bw. The acute oral LD50 for males and females was 2550 mg/kg bw.