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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:
07/09/1990 to 21/09/1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FIFRA (40 CFR)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: TSCA (40 CFR)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: OECD - Not specified
Deviations:
not specified
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexaboron dizinc undecaoxide
EC Number:
235-804-2
EC Name:
Hexaboron dizinc undecaoxide
Cas Number:
12767-90-7
Molecular formula:
B6O11Zn2
IUPAC Name:
hexaboron dizinc undecaoxide
Details on test material:
- Name of test material: XPI-187 zinc borate
- Physical state: Fine white powder
- Storage condition of test material: At room temperature in a large plastic Nalgene bottle with a lid.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc.
- Age at study initiation: Young adult
- Weight at study initiation: 228 - 301 g
- Fasting period before study: Overnight
- Housing: In groups of five in wire mesh suspension cages.
- Diet: Ad libitum, except for fasting period.
- Water: Ad libitum
- Acclimation period: At least 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h dark/light cycle.

IN-LIFE DATES: From: 07/09/1990 To: 21/09/1990

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % w/v
Doses:
5 g/kg
No. of animals per sex per dose:
Five/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for gross signs of systemic toxicity and mortality several times during the day of dosing and at least twice daily thereafter for a total of 14 days. Body weights were measured for each animal on the day of dosing, on Day 7 and at the time of necropsy.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Based on:
test mat.
Remarks on result:
other: The LD50 was greater than the limit dose. No clinically relevant mortality was observed.
Mortality:
One death was observed on Day 3 of the observation period but was not deemed clinically relevant.
Clinical signs:
Clinical signs included faecal stains, depression and unkempt fur.
Body weight:
See table.
Gross pathology:
No relevant gross pathology was observed. The gross necropsy findings in the animals that died during the observation period were those generally seen in agonal animals.

Any other information on results incl. tables

Body weight data in male and female rats treated orally with a 50 % w/v formulation of XPI-187 zinc borate in corn oil at a dose level of 5.0 g/kg:

Animal

No.

Sex

Body weight (g)

Body weight change

Day 0 – 14 (g)

Day 0

Day 7

Day 14

1-1761

M

279

229a

ND

N/A

2-*

M

263

323

349

86

3-1763

M

264

309

343

79

4-1764

M

301

339

372

71

5-1765

M

285

238

400

115

Mean (SD)

278 (16)

302 (45)

366 (26)

88 (19)

6-1766

F

238

273

278

40

7-1767

F

249

302

321

72

8-1768

F

252

305

298

46

9-1769

F

228

266

271

43

10-1770

F

241

278

285

44

Mean (SD)

242 (10)

285 (18)

291 (20)

49 (13)

a body weight taken at death and was not used in the calculation of the mean or standard deviation.

* lost ear tag prior to dosing

ND - No data

N/A - Not applicable

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: other: 40 CFR 156
Conclusions:
The acute oral toxicity of XPI-187 zinc borate was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR), the Toxic Substances Control Act and OECD Guidelines. The acute oral LD50 value was found to be greater than 5.0 g/kg in male and female Sprague-Dawley rats and was greater than the limit dose. The test material was classified in Toxicity Category IV (40 CFR 156) by oral administration.