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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 February 1993 - 27 March 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis(O,O-diisooctyl) bis(dithiophosphate)
EC Number:
249-109-7
EC Name:
Zinc bis(O,O-diisooctyl) bis(dithiophosphate)
Cas Number:
28629-66-5
Molecular formula:
Too complex
IUPAC Name:
zinc bis(O,O-diisooctyl) bis(dithiophosphate)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products Inc.
- Weight at study initiation: 3791 to 4961 grams.
- Housing: Individual suspended mesh-bottom cages.
- Acclimation period: minimum of 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9-20
- Humidity (%):28-48%.
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark.

IN-LIFE DATES: 22 February 1993 – 27 March 1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Mineral oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
In group 1 the test material was dosed (0.5ml/site) as received. In group 2, there were four intact sites per rabbit. Each rabbit was administered single applications (0.5ml/site) of the test material at at 6.25, 12.5, 25, and 50% concentration in mineral oil .
Duration of treatment / exposure:
The test substance was administered once per site and remained in contact with the skin for 4 hours followed by removal with disposable paper towels moistened with light, white mineral oil.
Observation period:
The skin was examined and graded for dermal reaction at 24 and 72 h following patch removal
Number of animals:
3 males and nine females
Details on study design:
On the day prior to dosing, the hair was removed from the backs of the rabbits using an Oster small animal clipper. Each animal received 0.5 milliliter dose was applied under a 2-ply 1" x 1" gauze patch, overwrapped with a gauze binder and secured with Dermiform Tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period (4 hours). Following the exposure period, residual test substance was removed with disposable paper towels moistened with light, white mineral oil.

SCORING SYSTEM: Dermal Irritation was graded in accordance with the Draize method of scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hour
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: neat test material
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: neat test material
Irritation parameter:
primary dermal irritation index (PDII)
Remarks on result:
other: neat test material
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 6.25 % in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 6.25% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.6
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 6.25% in mineral oil
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 12.5% in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 12.5% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
3.5
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 12.5% in mineral oil
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.8
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 25% in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.8
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 25% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
3.6
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 25% in mineral oil
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
2.9
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 50% in mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 50% in mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
4.1
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 50% in mineral oil
Irritant / corrosive response data:
Undiluted test material induced moderate erythema and slight edema on all rabbits. There were no other dermal findings.

The 6.25% concentration of the test material induced slight to moderate erythema on all rabbits and very slight edema on four rabbits. There were no other dermal findings.

The 12.5 % concentration of the test material induced slight to moderate erythema and very slight to slight edema on all animals. There were no other dermal findings.

The 25 % concentration of the test material induced moderate erythema and very slight to slight edema on all animals. There were no other dermal findings.

The 50 % concentration of the test material induced moderate erythema and very slight to slight edema on all rabbits. There were no other dermal findings.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the test substance would be classified as a Category 2 irritant in accordance with the GHS classification system
Executive summary:

The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits. There were two groups of six rabbits. In Group 1, single 0.5 milliliter doses of undiluted test material were applied to a single site on each animal's back. In Group 2, single 0.5 milliliter doses of the test material at concentrations of 6.25, 12.5, 25 and 50% (weight to volume in mineral oil) were applied to four distinct application sites on eachanimal'sback; each animal received a single dose of each concentration.Alldoses were applied under semi-occlusive dressing forafour hour exposure period. At completion of exposure the bandages were removed and the sites washed with light, white mineral oil and disposable paper towels. Application sites were evaluatedinaccordance with the method of Draize at approximately 24 and 72 hours after patch removal.