Hexaboron dizinc undecaoxide

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FIFRA (40 CFR)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: TSCA (40 CFR)

Deviations:

not specified

Test guideline 3

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

Test material information

Constituent 1

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:

other: Clinical signs included faecal stains, depression and unkempt fur.

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	229^a	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.