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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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Study conducted on the hydrolysis product of reference substance, boric acid.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FIFRA (40 CFR 163)
Deviations:
no
GLP compliance:
no
Remarks:
Study pre-dates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Boric acid
EC Number:
233-139-2
EC Name:
Boric acid
Cas Number:
10043-35-3
Molecular formula:
BH3O3
IUPAC Name:
Boric acid
Test material form:
other: solid
Details on test material:
- Name of test material: Boric acid
- Molecular formula: H3BO3
- Molecular weight: 61.8
- Smiles notation: B(OH)3
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: >99.0 % w/w
- Lot/batch No.: OA 107-3
- Stability under test conditions: Stable
- Other: White powder and odourless

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan F Plummer
- Weight at study initiation: 1623 - 2922 g

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: Moistened with physiological saline.
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
10
Details on study design:
TEST SITE
- Area of exposure: Saddle area
- Type of wrap if used: Occlusive


REMOVAL OF TEST SUBSTANCE
- Washing: Moistened towel
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
No irritancy was observed
Other effects:
No data

Any other information on results incl. tables

Results for skin irritation:

Site

Time

Erythema

Edema

Intact

24 h

0

0

72 h

0.25

0

Abraded

24 h

0

0

72 h

0.17

0

Average score

24 h, 72 h

0.105

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was performed according to FIFRA (40 CFR 163). No irritancy was observed and it is therefore not classifiable in the EU.
Further testing not warranted in the interests of animal welfare.

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