Registration Dossier
Registration Dossier
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EC number: 907-870-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Magnusson and Kligman Test
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was already available and considered to be the key study.
Test material
- Reference substance name:
- Reaction mass of bis(2-methylpropyl) pentanedioate, bis(2-methylpropyl) hexanedioate, bis(2-methylpropyl) butanedioate
- IUPAC Name:
- Reaction mass of bis(2-methylpropyl) pentanedioate, bis(2-methylpropyl) hexanedioate, bis(2-methylpropyl) butanedioate
- Reference substance name:
- 1,4-bis(2-methylpropyl) butanedioate; 1,5-bis(2-methylpropyl) pentanedioate; 1,6-bis(2-methylpropyl) hexanedioate
- EC Number:
- 907-870-9
- Molecular formula:
- Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
- IUPAC Name:
- 1,4-bis(2-methylpropyl) butanedioate; 1,5-bis(2-methylpropyl) pentanedioate; 1,6-bis(2-methylpropyl) hexanedioate
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Test Substance / Item : COASOL
Code by test facility : D08-11
Lot No. : 50046869
Manufactured by: Dow Haltermann Custom Processing, Middlesbrough, UK
Date of receipt at test facility : October 5, 2009
Purity as per Certificate of Analysis: 99% total diester content
Physical appearance : Colorless liquid
Storage conditions : Ambient (+18 to +30°C)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- DMSO
- Concentration / amount:
- Intradermal Induction: 5% v/v in DMSO
Epicutaneous induction and Challenge: 100% undiluted test material
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- DMSO
- Concentration / amount:
- Intradermal Induction: 5% v/v in DMSO
Epicutaneous induction and Challenge: 100% undiluted test material
Dosing solutions:
Control group:
Solution-1: 20 mL of 50% v/v CFA mixture (10 mL of CFA + 10 mL of distilled water) with 20 mL of DMSO was mixed as a 1:1 mixture and vortexed.
Solution-2: Undiluted DMSO.
Solution-3: 10 mL of solution 1 with 10 mL of solution 2 was mixed as a 1:1 mixture and vortexed.
Treatment group:
Solution-4: 5% v/v of test substance in Dimethyl Sulphoxide : 1 mL of test substance was made up to 20 mL and vortexed.
Solution-5: 1 mL of test substance made up to 10 mL with Dimethyl Sulphoxide (i.e., 10% v/v) and added to 10 mL of solution 1 (10 mL of 1 : 1 mixture of solution-1 and solution-2) to achieve the final concentration of 5 % v/v and vortexed.
- No. of animals per dose:
- 10 per sex per dose in treatment group
5 per sex per dose in control group - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
There were no toxic signs during the study nor any pre-terminal deaths. All animals gained weight throughout the observation period. There were no signs of irritation or sensitisation during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was not sensitising under the circumstances of this study at the highest doses possible (100%) for topical induction and challenge.
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