Registration Dossier
Registration Dossier
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EC number: 223-498-3 | CAS number: 3926-62-3
Skin sensitisation
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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC, No 440/2008; B42: "Skin Sensitization: Local Lymph Node Assay"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium chloroacetate
- EC Number:
- 223-498-3
- EC Name:
- Sodium chloroacetate
- Cas Number:
- 3926-62-3
- Molecular formula:
- C2H2ClNaO2
- IUPAC Name:
- sodium chloroacetate
- 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)
Constituent 1
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.
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