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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb. 2018
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA): BrdU-ELISA
Specific details on test material used for the study:
Composition:
Hexanedioic acid, mixed esters with decanoic acid, heptanoic acid, octanoic acid and pentaerythritol
EC#268-597-2, CAS #68130-55-2

Homogeneity: Homogenous liquid
Density: 0.97 (25 °C)
pH: 6 - 8 (due to water insolubility, forcibly dispersed state)
Physical features: Pale yellow liquid, no odour
Batch or Lot No: 026X6
Species:
mouse
Strain:
Balb/c
Sex:
female
Details on test animals and environmental conditions:
Source: lnVivos Pte Ltd
Animal Holding Facility: TÜV SÜD PSB Pte Ltd,
Housing condition: OptiMICE Caging Systems
Temperature: 18-26 °C
Humidity: 30 - 70%
Food: Altromin Maintenance Diet #1324
Water: Tap water
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100%, 50% and 25% (v/v)
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
Based on the above study, mean SI of the Positive Control group was 17.907 (>1 .6). Hence, using 50% (v/v) HCA in Acetone : Olive oil (4:1, v/v) as positive control substance, skin sensitization was produced in mice.
Key result
Parameter:
SI
Value:
4.91
Test group / Remarks:
Test group 1 - 100% test (v/v)
Key result
Parameter:
SI
Value:
4.712
Test group / Remarks:
Test group 1 - 50% test (v/v)
Key result
Parameter:
SI
Value:
4.436
Test group / Remarks:
Test group 3 - 25% test (v/v)
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Based on the above study, using 100%, 50% and 25% (v/v) of the test item - Mixed esters with CAS
No. 68130-55-2, Lot No: 026X6 as test substances and acetone : Olive oil (4:1, v/v) as vehicle and
negative control, skin sensitization was produced in mice.
Executive summary:

Based on the above study, mean SI of the Test group 1 (100% test item, v/v) was 4.91 O (>

1.6), mean SI of the Test group 2 (50% test item, v/v) was 4.712 (> 1.6), mean SI of the

Test group 3 (25% test item, v/v) was 4.436 (> 1.6). Hence, using 100%, 50% and 25%

(v/v) of the test item as test substances, skin sensitization was produced in mice.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification