Registration Dossier
Registration Dossier
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EC number: 230-072-0 | CAS number: 6938-94-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin sensitization potential of test chemical
- Author:
- Mary Ann Liebert
- Year:
- 1 984
- Bibliographic source:
- JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY,1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine skin sensitization potential of test chemical
- GLP compliance:
- not specified
- Type of study:
- other: Human Repeat Insult Patch Test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Human Repeat Insult Patch Test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD
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 the test material : Diisopropyl adipate
- Molecular formula: C12H22O4
- Molecular weight : 230.30 g/mol
- Smiles : O(C(CCCCC(OC(C)C)=O)=O)C(C)C
- Inchl:1S/C12H22O4/c1-9(2)15-11(13)7-5-6-8-12(14)16-10(3)4/h9-10H,5-8H2,1-4H3
-Physical state : liquid
-Substance type : Organic
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 3.0%
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: not specified
- Vehicle:
- not specified
- Concentration / amount:
- 3.0 %
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 50 men and women
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:10
- Exposure period:24 h
- Test groups:55
- Control group: not specified
- Site:not specified
- Frequency of applications: not specified
- Duration: not specified
- Concentrations:3.0%
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:After 7 days of resting period,challenge patch was applied
- Exposure period:24 h
- Test groups:55
- Control group: not specified
- Site: not specified
- Concentrations:3.0%
- Evaluation (hr after challenge):24 and 48 h - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not specified
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3.0%
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Human Repeat Insult Patch Test was conducted on 50 male and female subjects to assess the skin sensitization potential of test chemical. A test was conducted using a suntan lotion containing
3.0% test chemical. During induction,10 patches were applied for exposure period of 24 hours. After a rest period of 7 days, a challenge patch was applied for exposure period of 24 hours.Observations were done after 24 and 48 hours. No skin sensitization reactions were produced in the 50 men and women panelists. Hence the test material was considered as not sensitizing to the human skin. - Executive summary:
Human Repeat Insult Patch Test was conducted on 50 male and female subjects to assess the skin sensitization potential of test chemical. A test was conducted using a suntan lotion containing 3.0% test chemical. During induction,10 patches were applied for exposure period of 24 hours. After a rest period of 7 days, a challenge patch was applied for exposure period of 24 hours.Observations were done after 24 and 48 hours. No skin sensitization reactions were produced in the 50 men and women panelists. Hence the test material was considered as not sensitizing to the human skin.
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