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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:
18 May 2009- 09 June 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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:
other: EC, No 440/2008; B42: "Skin Sensitization: Local Lymph Node Assay"
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium Monochloroacetate (SMCA)
- Physical state: powder
- Analytical purity: 99.12% w/w
- Lot/batch No.:08.07.314
- Expiration date of the lot/batch: 04 May 2010 (allocated by NOTOX, 1 year after receipt of the test substance)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: 10 weeks
- Weight at study initiation: 20-24 g
- Housing: Individual housing in labeled Macrolon cages (MI type; height 12.5 cm) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom) was supplied as cage-enrichment.
The paper was removed on Day 1 prior to dosing and was supplied again after scoring of the ears on Day 3.

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21.0 - 24.2ºC
- Humidity (%):39 - 73%
- Air changes (per hr):approximately 15x
- Photoperiod (hrs dark / hrs light):12/12 hours

IN-LIFE DATES: From: 18 May 2009 To:09 June 2009

Study design: in vivo (LLNA)

Vehicle:
other: 1% watery pluronic L92
Concentration:
5, 10, 25%
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Irritation: no irritation
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: EC3

TREATMENT PREPARATION AND ADMINISTRATION:
The dorsal surface of both ears was epidermally treated (25 μL/ear) with the test substance concentration, at approximately the same time per day. The concentrations were mixed thoroughly using a vortex mixer immediately prior to dosing. The control animals were treated the same as the experimental animals, except that, instead of the test substance, the vehicle alone was administered.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
none

Results and discussion

Positive control results:
Positive control SI = 3.2

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
0.73
Test group / Remarks:
5%
Parameter:
SI
Value:
0.83
Test group / Remarks:
10%
Parameter:
SI
Value:
1.39
Test group / Remarks:
25%
Cellular proliferation data / Observations:
mean DPM ± SEM:
5%: 238±35 3
10%: 273±79 4
25%: 455±36 5
25% HCA 1038 ± 158 1
vehicle 327± 31

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
SMCA is not a skin sensitizer as SI values were below 3.