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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:
1986/10/07-1986/10/20
Reliability:
1 (reliable without restriction)

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)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts
EC Number:
272-723-1
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts
Cas Number:
68909-93-3
Molecular formula:
Too complex
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts
Details on test material:
Test material from lot no. EC-47904 is described as pale amber viscous liquid with pH 5.34

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 male and 3 female rabbits supplied by Sgarlat's Rabbitry were acclimated to the laboratory for 5 days prior to study initiation. Apparently healthy rabbits were selected for the study and housed 1/cage in cages sized according to National Research Council standards. The rabbit rooms were maintained at 20 °C with humidity between 30-70% and 12 h light cycles. Wayne Rabbit Ration and tap water were freely available.

Test system

Type of coverage:
occlusive
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 with deionized water
Observation period:
13 days
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 a rubber dam and Ace bandage for 4 h. Following the exposure period, residual test substance was removed with deionized water and animals were scored for erythema, edema, and necrosis 1, 24, 48, 72 h and daily for 13 days following removal of the test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.5
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
Very slight to moderate erythema was observed at 1 h through Day 9 after application of the test material. Very slight to slight edema was observed at 1h and through Day 9 after application of the test material. Fissuring was observed on Days 4-6 and sloughing was observed on Days 7-12.
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 in male and female New Zealand White rabbits.
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 1, 24, 48 and 72 h post removal of test material and daily for 13 days. The mean erythema and edema scores were 2.5 and 1.33, respectively. Very slight to moderate erythema and very slight to slight edema were observed until Day 9 post removal of the test substance with deionized water. 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.