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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
EC Number:
288-917-4
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
Cas Number:
85940-28-9
Molecular formula:
C23.H50.O4.S4.P2.Zn
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
Details on test material:
- Physical state: liquid
- Analytical purity: 100%
- Effective substances: solution of Zn-dialkyldithiophosphate (about 80%) in mineral oil (about 20%)
- Batch No.: 205 92 08
- Expiration date: May 1993
- Stability under test conditions: stable at dry storage

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kurt Meckel, Laubach-Ruppertsburg, Germany
- Weight at study initiation: 2641 - 2680 g
- Acclimation period: 5 days

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL / animal
Duration of treatment / exposure:
4 hours
Observation period:
10 days
Number of animals:
3; 2 males, 1 female
Details on study design:
One day before treatment the dorsal area of the trunk was shaved in an area of 3 x 5 cm2.
The test substance was dermally applied in a single dose of 0.5 mL/animal onto the dorso-lumbar region of 3 albino rabbits. The region treated was protected with gauze and with an occlusive bandage for a period of 4 hours. At the end of the exposure period the residual test substance was removed by gently washing with water.
The evaluation of the skin reaction was done according to OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: female
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: female
Irritant / corrosive response data:
After removing the occlusive bandage after a period of 4 h, the exposure area was washed and cleaned with water. In the following observation period dermal irritations of the exposure area in form of a very slight erythema could be observed.
Other effects:
Mortality: none of the rabbits died during the experiment.
Toxicological symptoms: During the observation period of 10 days none of the animals showed toxicological signs.
Behaviour: The reaction of the animals treated was quiet and watchful. The behaviour pattern was normal.
Body weight: The body weight of all animals had a normal physiological growth.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU / GHS-EU
Conclusions:
The substance is not irritating to skin. The test substance does not meet the criteria for EU or GHS-EU classification.