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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:
1986
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:
1986
Report date:
1986

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts
EC Number:
270-608-0
EC Name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts
Cas Number:
68457-79-4
Molecular formula:
{[(iso-C4H9O)0.64(C5H11O)0.36]PS2}2Zn - neutral, {[(iso-C4H9O)0.64(C5H11O)0.36]PS2}6Zn4O - basic
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

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., Denver PA
- Weight at study initiation: 2.59- 2.64 kg males and 2.65- 2.97 kg females.
- Housing: Individual suspended stainless steel cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum

- Acclimation period: 22 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-21.6
- Humidity (%):40-60%.
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark.

IN-LIFE DATES: 5 August 1986 – 12 August 1986

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
The test material was dosed (0.5ml/site) as received.
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 60 minutes, 24, 48 , and 72 h following patch removal and on Day 7.
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
On the day prior to dosing, the hair was removed from the shoulder region tot eh lumbar region with electric clipper. Each animal received 0.5 ml dose to two separate sites (right dorsal thoracic and left dorsal thoracic) under a gauze patch which was secured with tape. The patch was loosely held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period. After approximately 4 hours of exposure, the dressing and gauze patch were removed. Residual test material on the right dorsal thoracic dose site was removed with paper towels saturated in distilled water; residual test material on the left dorsal thoracic dose site was removed with paper towels saturated in white 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, 48 and 72 hours
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: sites wiped with water
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: sites wiped with water
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: sites wiped with oil
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: sites wiped with oil
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
4.4
Max. score:
8
Reversibility:
other: not applicable
Remarks on result:
other: sites wiped with water
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
4
Max. score:
8
Reversibility:
other: not applicable
Remarks on result:
other: sites wiped with oil
Irritant / corrosive response data:
At the 60 minute observation, all animals exhibited very slight to well-defined erythema at both dose sites. Edema at this time ranged from very slight to slight for four animals at the right dose site (test article removed with distilled water), while three animals exhibited very slight edema at the left dose site (test article removed with white oil). Erythema and edema scores increased at the 24, 48, and 72 hour observations, with the right dose site exhibiting slightly higher scores than the left dose site. Irritation decreased at both dose sites on Day 7 when all animals displayed very slight to well defined erythema and five animals showed very slight to slight edema. However scores at the right dose site were again slightly higher than the left dose sight

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 in accordance with the classification system of GHS
Executive summary:

The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits. The test material was administered to two separate sites (right dorsal thoracic and left dorsal thoracic). At each single site, 0.5 ml doses of undiluted test material were applied under gauze patch which was secured with tape. The patch was loosely held in contact with the skin by means of a semi-occlusive dressing for a four hour exposure period. At completion of exposure the dressing and gauze were removed and the right dorsal thoracic site was removed with paper towels moistened with distilled water; residual test material on the left dorsal thoracic dose site was removed with paper towels saturate in white oil. Application sites were evaluated in accordance with the method of Draize at approximately 60 minutes, 24, 48, and 72 hours and Day 7 after patch removal.

ThePrimary Irritation Index was calculated to be 4.42 for sites wiped with distilled water.

ThePrimary Irritation Index was calculated to be 4.0 for sites wiped with white oil.

Based on the results of this study, the test substance as supplied would be classified as a Category 2 in accordance with the classification system of GHS