Boric acid, zinc salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

28/08/1990 - 19/10/1990

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: federal Insecticide, Fungicide and Rodenticide Act (40 CFR)

Deviations:

not specified

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Toxic Substances Control Act (40 CFR)

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
- Substance type: Inorganic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:King's Wheel Rabbitry
- Age at study initiation: Young adult
- Weight at study initiation: 2256 - 2438 g
- Housing: Singly in wire mesh suspension cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 4 days.

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

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used: The test material was applied to sleeves of rubber dental dam. each sleeve was wrapped around the trunk of the respective animal and secured with staples. An outer layer of gauze was wrapped around the trunk of each animal and secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Any unabsorbed test material remaining on the skin was removed by gentle sponging using a towel moistened with water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 5.0 g/kg
- Concentration: The test material was used as received and moistened with an appropriate volume of physiological saline prior to administration.
- Constant volume or concentration used: No data
- For solids, paste formed: Yes

Duration of exposure:

24 h

Doses:

5 g/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for signs of toxicity and behavioural change once a day with an additional check for viability during the day.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs were noted once daily; body weight was measured on the day of dosing, on Day 7 and at the time of necropsy at the end of the 14-day observaiton period; skin reactions and other evidene of irritaiton or injury were noted once daily.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths were noted during the observation period.

Mortality:

No deaths were noted during the observation period.

Any other information on results incl. tables

The acute dermal 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, the Toxic Substances Control Act and the OECD Guidelines

No deaths were noted during the observation period

The acute dermal LD50 value was found to be >5.0 g/kg in male and female New Zealand White rabbits

Body weight data

Animal number	Sex	Body weight (g)			Body weight change (g)
		Day 0	Day 7	Day 14	Day 0 – 14
1-939	M	2770	2945	3037	267
2-940	M	3133	3289	3549	416
3-943	M	2919	2868	3119	200
4-943	M	3068	3112	3329	261
5-950	M	2256	2436	2395	139
Mean		2839	2930	3086	257
6-959	F	2943	3208	3417	474
7-960	F	3257	3208	3474	217
8-961	F	3438	3249	3727	289
9-962	F	2508	3601	2802	294
10-963	F	3319	3519	3645	326
Mean		3093	3231	3413	320

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute dermal toxicity of the test substance was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide and Rodenticide Act 940 CFR) the TSCA (40 CFR) and the OECD guidelines. No deaths were noted during the observation period. The acute dermal LD50 was found to be greater than 5.0 g/kg in male and female New Zealand White rabbits. The test material was classified as Toxicity Category IV (40 CFR 156) by dermal administration.