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Toxicological information

Skin sensitisation

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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:
other: Standar Guideline OECD study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
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

Constituent 1
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
Constituent 2
Chemical structure
Reference substance name:
Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
EC Number:
907-870-9
Molecular formula:
Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
IUPAC Name:
Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
Test material form:
liquid
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.
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.
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.
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.

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.