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Administrative data

Description of key information

In an OECD 429 guideline study (Skin Sensitisation: Local Lymph Node Assay) no adverse effect was observed. The test item was not sensitising.

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:
Experimental Starting Date: 2007 May 02. Experimental Completion Date: 2007 May 17.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
The test item Sandoplast Red Violet R suspended in DMSO was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5, and 10%.
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Purity: 99.19 %
Species:
mouse
Strain:
other: CBAfCaOlaHsd
Sex:
female
Details on test animals and environmental conditions:
Animal species:
Test System: Mice, CBAfCaOlaHsd
Rationale: Recognised as the recommended test system
Source: Harlan Netherlands
Number of animals for
the pre-test (non-GLP): 2 females
Number of animals for
the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age: 7-8 weeks (beginning of acclimatisation)
Identification: Single caging. The animals were distributed into the test groups at random and identified by cage number.
Acclimatisation: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.

Husbandry
The animals were kept conventionally. The experiment was conducted under Standard laboratory conditions.
Housing: single
Gage Type: Makrolon Type I, with wire mesh top
Bedding: granulated soft wood bedding
Feed: pelleted Standard diet, ad libitum
Water: tap water, ad libitum,
Environment: temperature 22 + 3°C, relative humidity 30-86%, artificial light 6.00 a.m. - 6.00 p.m.
Vehicle:
dimethyl sulphoxide
Concentration:
2.5, 5, and 10% (w/v) in DWISO
No. of animals per dose:
4 female mice per dose
Details on study design:
ln Order to study a possible allergenic potential of Sandoplast Red Violet R, three groups each of four female mice were treated with different concentrations of the test ite by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radiolabelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled
lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a ß-scintillation counter.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the Stimulation index.
- Second, that the data are compatible with a oonventional dose response, although allowance must be made (especially at high topical ooncentrations) for either local toxicity or immunological suppression.
The decision to select a STIMULATIO INDEX (S.l.) of 3 as an arbitrary indication of sensitizing activity was made on the basis of investigations performed with a wide range of chemicals.
Positive control results:
The sensitivity and reliability of the experimental technique employed was assessed by use of a substance which is known to have s in sensitisation properties in CBA/CaOlaHsd mice. The validation- / positive control experiment was performed with a-Hexylcinnamaldehyde in acetone:olive oil (4+1) using CBA/CaOlaHsd mice in December 2006.
Key result
Parameter:
SI
Value:
2.44
Test group / Remarks:
Test item concentration % (w/v): 2.5
Key result
Parameter:
SI
Value:
0.94
Test group / Remarks:
Test item concentration % (w/v): 5
Key result
Parameter:
SI
Value:
2.59
Test group / Remarks:
Test item concentration % (w/v): 10

In this study Stimulation Indices of 2.44, 0.94, and 2.59 were determined with the test item at concentrations of 2.5, 5, and 10% in DMSO. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.

Interpretation of results:
GHS criteria not met
Conclusions:
The test item Sandoplast Red Violet R was not a skin sensitiser under the described conditions.
Executive summary:

In the study the test item Sandoplast Red Violet R suspended in DMSO was assessed for its possible contact allergenic potential.

For this purpose a local ly ph node assay was performed using test item concentrations of 2.5, 5, and 10%.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Due to the colour of the test item, irritation of the ear skin could not be observed.

In this study Stimulation Indices (S.I.) of 2.44, 0.94, and 2.59 were determined with the test item at concentrations of 2.5, 5, and 10% in DMSO, respectively.

The test item Sandoplast Red Violet R was not a skin sensitiser in this assay.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a LLNA the test item Sandoplast Red Violet R was not a skin sensitiser (negative).

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.