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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28/08/1990 - 28/09/1990
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:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: Federal Insecticide, Fungicide and Rodenticide Act 40 CFR
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Toxic Substances Control Act (40 CFR)
Deviations:
not specified
GLP compliance:
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:
dizinc(2+) tris(oxo[(oxoboranyl)oxy]borane) dioxidandiide
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
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:
- Housing: Singly in wire mesh suspension cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least one day.

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: Test substance was moistened with 0.5 mL physiological saline.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3/sex
Details on study design:
TEST SITE
- Area of exposure:
- % coverage: Not specified; approxiamtely 1 inch.
- Type of wrap if used: gauze patch, two layers thick, held in place with adhesive tape. After application of the patch, the trunk of each rabbit was wrapped with rubber dental darn 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: Residual test material was removed by a gentle sponging using a towel moistened with water or other appropriate solvent.
- Time after start of exposure: 4 h

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
ca. 0.2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Based on erythema and edema.
Irritant / corrosive response data:
No irritation persisted 72 hours following application. No changes in the colouration or texture of the skin were noted. No evidence of corrosion was found.
Other effects:
None noted

Any other information on results incl. tables

The Primary skin irritancy 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.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The primary skin irritation was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide and Rodenticide Act, the TSCA and the OECD guidelines. No irritation persisted 72 h following application. The PII was found to be 0.2 on erythema and edema. No changes in colouration or texture of the skin were noted. No evidence of corrosion (necrosis) was found. The test material was classified as Toxicity Category IV (40 CFR 156) by dermal administration.