Registration Dossier
Registration Dossier
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EC number: 288-917-4 | CAS number: 85940-28-9
Skin irritation / corrosion
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:
- 1 992
- 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
- 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
Constituent 1
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.
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