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Description of key information

Acute oral, dermal and inhalation toxicity studies have been performed with disodium octaborate tetrahydrate. Experimental data showed low acute toxicity to disodium octaborate tetrahydrate. The mean of the male and female values were obtained from the key study (oral route; Doyle 1988). The LD50 (oral) is equivalent to 534.5 mg B/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
other: FIFRA (40 CFR)
Deviations:
not specified
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
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
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
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:
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 observed: Fecal stains, mild to extreme depression, dried brown stains around the eyes and nose, piloerection, loose mucoid faeces on the cage paper, hunched posture, comatose, laboured breathing, dried red material around muzzles or on head, body tremours and dirty hair coats.
At 2.0 g/kg the following clinical changes were observed: Mild to severe depression, faecal stains, piloerection,loose mucoid stains on cage paper, dirty hair coats and eye squinting.
At 1.25 g/kg the following clinical changes were observed: Mild depression, faecal stains and loose mucoid faeces on the cage paper.
Body weight:
See table.
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

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

Dosage

(g/kg)

Cumulative No. of deathsa

Observationsb

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)

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 550 mg/kg bw
Quality of whole database:
High quality (Guideline study).

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA
- Age at study initiation: Young adult
- Weight at study initiation: Males 224-260 g; females 207 -234 g
Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: no data
Details on inhalation exposure:
TEST ATMOSPHERE
- Particle size distribution: Not an aerosol study
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD 2.8 µm + GSD 2.15 µm

- Rationale for the selection of the starting concentration: Top dose ~ 2 mg/L was the highest that was obtainable under the conditions of the test
Analytical verification of test atmosphere concentrations:
yes
Remarks:
No further details
Duration of exposure:
4 h
Concentrations:
Nominal concentration 2000 mg/m³
Analytical concentration 2010 ± 140 mg/m³
No. of animals per sex per dose:
5/sex/group
Control animals:
no
Details on study design:
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs
Statistics:
No data
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.01 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No data
Clinical signs:
other: Animal observations were limited due to the accumulation of test material on the walls of the exposure chamber. During exposure, ocular discharge, hypoactivity and haunched posture were noted. All animals recovered after removal from chamber.
Body weight:
See table
Gross pathology:
No specific findings observed except red lung discolouration consistent with CO2 inhalation (caused by euthanasia technique). All tissue sand organs were normal.
Other findings:
No data

Gravimetric chamber concentrations:

Sample

No.

Mass

collected

(mg)

Airflow

sampled

(Lpm)

Collection

time

(min)

Chamber

concentration

(mg/L)

1

14.5

4

2

1.81

2

19.1

4

2

2.38

3

15.4

4

2

1.93

4

17.5

4

2

2.19

5

17.1

4

2

2.14

6

14.6

4

2

1.83

7

14.4

4

2

1.80

Average ± Standard deviation

2.01 ± 0.23

Summary of particle size distribution:

Sample

No.

Sampling

time

(min)

Mass mean

aerodynamics

diameter (μm)1

Geometric

standard

deviation

1

2

2.7

2.08

2

2

2.8

2.15

1 This figure is an estimation based on graphic analysis of the particle size distribution as measured with an Andersen Cascade Impactor

Individual body weights:

Animal

No.

Sex

Body weight (g)

Initial

Day 7

Day 14

5409

M

224

338

376

5410

M

256

332

374

5411

M

224

303

351

5412

M

260

340

392

5413

M

225

296

329

5414

F

207

232

240

5415

F

215

223

231

5416

F

215

235

249

5417

F

234

250

253

5418

F

207

222

233

Interpretation of results:
other: EU GHS Criteria not met
Conclusions:
The sample was ground in a ball mill for 24 hours to give a MMAD 2.8 µm + GSD 2.15 µm
Top dose ~ 2 mg/L was the highest that was obtainable under the conditions of the test. The acute inhalation LC50 was > 2.01 mg/L (2.01 g/m³).
Executive summary:

The test item disodium octaborate tetrahydrate was assessed for inhalation acute toxicity in rats in a GLP study according to OECD Guideline 403. Five animals per sex per dose were exposed per whole body to a maximum attainable test item concentration of 2.01 mg/L for 4 hours. The acute inhalation LC50 was > 2.01 mg/L (2.01 g/m³).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
2 010 mg/m³
Quality of whole database:
High quality (Guideline study).

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Qualifier:
according to guideline
Guideline:
other: FIFRA (40 CFR 158, 162); TSCA (40 CFR 798)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm
- Weight at study initiation: Males: 2720 -3379 g; females: 2699 –3057 g
Type of coverage:
semiocclusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: No data
- % coverage: Not specified but implies > 10 % of body surface
- Type of wrap if used: Semi occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Moist towel
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dosage to 2 g/kg bw
Duration of exposure:
24 h
Doses:
Dosage to 2 g/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No data
- Other examinations performed: Clinical signs and histopathology
Statistics:
No data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No lethal effect at limit dose
Clinical signs:
No clinical changes were observed
Body weight:
No data
Gross pathology:
No gross necropsy findings were observed.
Other findings:
No data
Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The acute dermal LD50 was > 2000 mg/kg bw indicating no acute dermal toxicity. No clinical or pathological findings were observed.
Executive summary:

The test item disodium octaborate tetrahydrate was assessed for dermal acute toxicity in rabbits in a GLP study according to OECD Guideline 402. Five animals per sex per dose were exposed via gavage to a single dose of the test item of 2.0 g/kg bw. The acute dermal LD50 for males and females was > 2000 mg/kg bw indicating no acute dermal toxicity. No clinical or pathological findings were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
High quality (Guideline study).

Additional information

LD50 values of >2000 mg/kg were recorded for both oral and dermal routes and > 2 mg/L for the acute inhalation study with disodium octaborate tetrahydrate. The inhalation figure represents the highest attainable concentration.

Disodium octaborate tetrahydrate is of low acute toxicity.

No information is available on the acute toxicity of disodium octaborate anhydrate.

Using read-across from disodium octaborate tetrahydrate with a correction for the difference in molecular weight is considered correct because no differences in uptake are expected and once taken up the effects will not significantly differ. This correction for differences in molecular weight results in an LD50 of 2105 mg/kg bw for disodium octaborate anhydrate. For acute dermal and inhalation toxicity also no mortality is expected at the limit dose (dermal) or the highest attainable dose (inhalation, LC50 > 1.65 mg/L). It is expected that the toxicity of disodium octaborate anhydrate and disodium octaborate tetrahydrate will be similar and that both substances do not need to be classified for acute oral, dermal and inhalation toxicity


Justification for classification or non-classification

Disodium octaborate tetrahydrate is not classified for the oral, dermal or inhalation route, as the LD50 values exceed the limit for classification according to Regulation (EC) No 1272/2008 (CLP Regulation).