Registration Dossier
Registration Dossier
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EC number: 230-072-0 | CAS number: 6938-94-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- reporting deficiencies, housing and purity not reported, 7 days observation period
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diisopropyl adipate
- EC Number:
- 230-072-0
- EC Name:
- Diisopropyl adipate
- Cas Number:
- 6938-94-9
- Molecular formula:
- C12H22O4
- IUPAC Name:
- 1,6-bis(propan-2-yl) hexanedioate
- Details on test material:
- - Name of test material (as cited in study report): adipate d'isopropyle
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.203 kg (males)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control.
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48, and 72 h and 4, 5, 6 and 7 days - Number of animals:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with aqua dest..
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effects seen
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: erythema grade 1 seen at 24 h only
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: erythema grade 1 seen from 24 h to 5 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of animals #1 and #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no edema seen
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: edema grade 1 seen at...
- Irritant / corrosive response data:
- Two out of three animals showed erythema graded 1 at time point 1 h. One out of three test animals displayed very slight erythema and edema, which was fully reversible within 6 days. One further animal (animal #2) showed erythema graded 1 at time point 24 h only.
- Other effects:
- Defatting of skin was evident at the test site in all three animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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