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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
In vivo study conducted in 2012 before the mandatory requirement for in vitro skin sensitisation test data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxypropyl 2-ethylhexanoate
EC Number:
261-499-0
EC Name:
2-hydroxypropyl 2-ethylhexanoate
Cas Number:
58921-10-1
Molecular formula:
C11H22O3
IUPAC Name:
2-hydroxypropyl 2-ethylhexanoate
Constituent 2
Chemical structure
Reference substance name:
1-hydroxypropan-2-yl 2-ethylhexanoate
Molecular formula:
C11H22O3
IUPAC Name:
1-hydroxypropan-2-yl 2-ethylhexanoate
impurity 1
Chemical structure
Reference substance name:
Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
IUPAC Name:
Monoesters of 2-ethylhexanoic acid and dipropyleneglycol
impurity 2
Chemical structure
Reference substance name:
1-methylethylene 2-ethylhexanoate
EC Number:
301-185-3
EC Name:
1-methylethylene 2-ethylhexanoate
Cas Number:
93981-97-6
Molecular formula:
C19H36O4
IUPAC Name:
propane-1,2-diyl bis(2-ethylhexanoate)
impurity 3
Chemical structure
Reference substance name:
2-ethylhexanoic acid
EC Number:
205-743-6
EC Name:
2-ethylhexanoic acid
Cas Number:
149-57-5
Molecular formula:
C8H16O2
IUPAC Name:
2-ethylhexanoic acid
impurity 4
Reference substance name:
Propane-1,2-diol, propoxylated
EC Number:
500-039-8
EC Name:
Propane-1,2-diol, propoxylated
Cas Number:
25322-69-4
IUPAC Name:
Propane-1,2-diol, propoxylated
impurity 5
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Water
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100, 50 and 25% v/v
No. of animals per dose:
4 females
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
SI = 5.76, Positive

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 25% = 1.48 50% = 1.92 100% = 0.94
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 25% = 23114.85 50% = 29906.12 100% = 14639.73

Any other information on results incl. tables

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not a skin sensitiser