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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: This study was carried out to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP.
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Sodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: USB-12-84
- Stability under test conditions: Stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LaCrosse Industries Inc.
- Age at study initiation: Young adults
- Weight at study initiation: 2.13 – 2.45 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Clipped
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
0.5 g of test substance was moistened with 0.5 mL physiological saline.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: Two areas on the back of each rabbit were treated.
- % coverage: No data
- Type of wrap if used: No data


REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed using a moistened towel.
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize, 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Not specified
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Not specified
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No adverse effects were seen.
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Skin irritation study carried out on disodium tetraborate pentahydrate to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP showed no irritancy was observed.