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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was designed to evaluate the implications of differences in test material removal on study outcome and therefore was not strictly an OECD 404 protocol. It was performed by GLP, however, and followed key elements of guidelines making findings reliable with restrictions.

Data source

Reference
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11-13 weeks
- Housing: Housed individually in wire-bottom cages
- Diet (e.g. ad libitum): rationed
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15-36 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.8-23.1
- Humidity (%): 60.6-68%
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap if used: gauze wrapped in plastic sheet


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with dry pad or wiped with gauze pads moistened with mineral oil followed by a dry gauze pad
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.3
Remarks on result:
other: Mineral oil wipe
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.5
Remarks on result:
other: Mineral oil wipe
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.8
Remarks on result:
other: Dry gauze wipe
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.3
Remarks on result:
other: Dry gauze wipe

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
When the test material was completely removed from the skin, irritation was substantially reduced to below thresholds requiring hazard classification.
Executive summary:

3 different zinc dialkyldithiophosphates were tested for skin irritation potential using two different methods of test material removal. This study demonstrates that appropriate procedures are required to ensure complete removal of hydprophobic test materials that are present in diluent oil.