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Diss Factsheets

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:
04/11/96-01/13/97
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 40CFR792
Deviations:
yes
Remarks:
Each rabbit had 4 test sites concurrently
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Each rabbit had 4 test sites concurrently.
Principles of method if other than guideline:
Two substances were tested at once and washed off with isopropanol or mineral oil. Sites 1 and 2 (upper left and right) were washed with mineral oil. Sites 3 and 4 (lower left and right) were washed with isopropanol.


GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and pentyl) esters, zinc salts
EC Number:
273-527-9
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and pentyl) esters, zinc salts
Cas Number:
68988-45-4
Molecular formula:
Not applicable
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and pentyl) esters, zinc salts
Details on test material:
The test material is described as clear, yellow liquid.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three male and 3 female rabbits supplied by Hazleton Research Products were acclimated to the laboratory for a minimum of 5 days prior to study initiation. Apparently healthy rabbits, 12-15 weeks, and weighing 2.322-2.561 kg were selected for the study and ear tagged. The temperature and humidity of the animal room was maintained at 16-21 C and 25-70%, respectively on 12 h light cycles. Rabbits were housed individually in stainless steel cages and PMI Certified Lab Rabbit Diet and fresh water were available ad libitum.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Test material was dosed as received, 0.5 ml/site, directly on the intact skin sites.


Duration of treatment / exposure:
Test substance was administered once per site and remained in contact with the skin for 4 h followed by removal of the substance by washing one site with mineral oil and the other with isopropanol.

Observation period:
Immediately and then daily after patch removal through Day 14.


Number of animals:
6 (3 male, 3 female)
Details on study design:
The test substance was applied to a small area of skin covered with a gauze patch and held in contact by semi-occlusive dressing and held in place with non-irritating tape for 4 h. Following the exposure period, residual test substance was removed from one site with mineral oil and the other site with isopropanol and were scored for erythema, edema, and necrosis immediately and then daily through day 14.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.8
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: washed with mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.7
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: washed with mineral oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.9
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: washed with isopropanol
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: washed with isopropanol
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.78
Max. score:
3
Reversibility:
fully reversible within: 14 days in 5/6 rabbits
Remarks on result:
other: washed with mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.44
Max. score:
3
Reversibility:
fully reversible within: 14 days in 5/6 rabbits
Remarks on result:
other: washed with mineral oil
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.61
Max. score:
3
Reversibility:
not fully reversible within: 14 days in 3/6 rabbits
Remarks on result:
other: washed with isopropanol
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days in 3/6 rabbits
Remarks on result:
other: washed with isopropanol
Irritant / corrosive response data:
Moderate to severe erythema and moderate edema were observed immediately following washing of the test site with both the mineral oil and isopropanol wash groups.
Other effects:
No other effects reported.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test material produced a positive irritant effect when washed with either isopropanol or mineral oil.
Executive summary:

In a skin irritation study, New Zealand White rabbits were treated with 0.5 ml of test substance for 4 h. Irritation responses were graded at 0, 24, 48 and 72 h post removal of test material. The modified primary irritation index was 4.8 when washed with mineral oil and 4.9 when washed with isopropanol. Moderate to severe erythema and moderate edema were observed immediately following washing of the test site with both the mineral oil and isopropanol wash groups. Based on the results of this study, the test substance would be classified Category 2 in accordance with the classification system of GHS. This toxicity study is classified as acceptable and satisfies the guideline requirement for skin irritation study in rabbits.