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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 February 2018 to 05 September 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NouSan No. 8147, 24 November 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
- CAS RN 1412893-77-6
- Purity: >94% (UVCB)
- Description: Brown paste to very viscous liquid

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/CaOlaHsd
Sex:
female
Details on test animals and environmental conditions:
The animals were housed in suspended solid floor polypropylene cages with stainless steel mesh lids and furnished with softwood flakes bedding (Datesand Ltd., Cheshire, UK).

The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70%, respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Test item at concentrations of 50, 25 or 10 (%v/v) in acetone/olive oil 4:1
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate.

Results and discussion

Positive control results:
α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
2.51
Test group / Remarks:
10% Concentration (% v/v) in acetone/olive oil 4:1
Key result
Parameter:
SI
Value:
6.64
Test group / Remarks:
25% Concentration (% v/v) in acetone/olive oil 4:1
Key result
Parameter:
EC3
Value:
11.8

Any other information on results incl. tables

Table 1: Stimulation Index of the Test Item

Concentration (%v/v) in
acetone/olive oil 4:1

Stimulation Index

Result

10

2.51

 Negative

25

6.64

 Positive

50

*

*

* No data, one animal found dead on Day 5 and remaining four animals humanely killed on Day 5 due to the occurrence of clinical signs of toxicity that were considered to approach/exceed the moderate severity limit set forth in the UK Home Office Project License.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The test material was considered to be a weak skin sensitizer with an EC3 of 11.8% under the conditions of the test.
Executive summary:

The study was performed to the standardised guidelines OECD 429, under GLP conditions. Following a preliminary screening test in a female mouse treated with the test item at a concentration of 50% v/v in acetone/olive oil 4:1, in which no clinical signs of toxicity were noted, this concentration was selected as the highest dose investigated in the main test.

Three groups, each of five female animals, were treated with 50 μL (25 μL per ear) of the test item, as a solution in acetone/olive oil 4:1, at concentrations of 50%, 25% or 10% v/v. A further group of five female animals was treated with acetone/olive oil 4:1 alone in the same manner.

Under the conditions of the test, the test item was considered to be a weak skin sensitizer with an EC3 of 11.8% under the conditions of the test and is classified as a contact sensitizer (Category 1B) according GHS.