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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:
16 September 2003 - 19 January 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

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:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Remarks:
CBA/Ca/Ola/Hsd
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Harlan Interfauna UK Limited, Blackthorne, Bicester, Oxon, UK. - Age at study initiation: Young adults- Weight at study initiation: No data- Housing: 4 animals/ cage- Diet (e.g. ad libitum): Ad libitum- Water (e.g. ad libitum): Ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 - Humidity (%): 30-70- Air changes (per hr): minimum of 15- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
other: ethanol/diethylphthalate 1:3
Concentration:
2.5%, 5%, 10%, 25% or 50% (w/v)
No. of animals per dose:
4
Details on study design:
PRE-SCREEN TESTS:Not performed.MAIN STUDY- Clinical observations: All animals were observed at least once daily for signs of systemic toxicity.- Body weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).ANIMAL ASSIGNMENT AND TREATMENT- Criteria used to consider a positive response: 3-fold or greater increase in dpm as compared to the control group (Stimulation Index > 3)TREATMENT PREPARATION AND ADMINISTRATION:- In accordance with OECD TG 429.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
The EC3 value was derived by interpolating between two points on the Stimulation Index (SI) axis, one immediately above and the other immediately below the SI value of 3. These datapoints have the co-ordinates "a" (concentration at SI immediately above 3), "b" (SI of "a"), c (concentration at SI immediately below 3) and d (the SI of "c"), which are used to calculate the EC3 value by use of the standardfollowing equation: EC3=[(3-d)/(b-d)]x(a-c)+c.

Results and discussion

Positive control results:
The application of the positive control item, Hexylcinnamaldehyde, resulted in a more than 3-fold increase in isotope incorporation for all three tested concentrations (SI > 6).

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
EC3
Test group / Remarks:
All test groups
Remarks on result:
not determinable
Remarks:
All SI < 3
Parameter:
SI
Value:
1.06
Test group / Remarks:
2.5% (w/v)
Parameter:
SI
Value:
1.01
Test group / Remarks:
5% (w/v)
Parameter:
SI
Value:
0.87
Test group / Remarks:
10% (w/v)
Parameter:
SI
Value:
0.95
Test group / Remarks:
25% (w/v)
Parameter:
SI
Value:
0.84
Test group / Remarks:
50% (w/v)
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATAMean DPM at 0 (vehicle), 2.5, 5, 10, 25 and 50% (w/v) were 5432, 5776, 5504, 4709, 5167 and 4536, respectively.DETAILS ON STIMULATION INDEX CALCULATIONThe following SI values were derived at 2.5, 5, 10, 25 and 50% (w/v): 1.06, 1.01, 0.87, 0.95, 0.84. EC3 CALCULATIONThe EC3 value could not be calculated because there were no concentrations tested that resulted in an SI ≥ 3. The EC3 value is therefore expected to be above 50% (w/v).CLINICAL OBSERVATIONS:No clinical signs reported.BODY WEIGHTS:Only raw data reported.

Applicant's summary and conclusion

Interpretation of results:
other: Not skin sensitizer
Remarks:
According to EU CLP 1272/2008 and its amendments.
Conclusions:
Under the conditions of this test, Etaphen did not induce a Stimulation Index (SI) above 3 and an EC3 value could not be calculated (>50%). Based on these results, the substance is considered not to be a sensitiser and does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP) and its amendments.
Executive summary:

The skin sensitisation potential of Etaphen has been tested according to OECD TG 429: Local Lymph Node Assay in mice. At doses of 2.5, 5, 10, 25 and 50% (w/v), the substance induced SI values of 1.06, 1.01, 0.87, 0.95 and 0.84, respectively. The EC3 could not be calculated as there were no concentrations tested that resulted in an SI ≥ 3. Based on these results, the substance is considered not to be a sensitiser and does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP)

and its amendments

.