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Administrative data

Description of key information

Key study is an LLNA performed with the sodium salt of MCA (3926 -62 -3), according to OECD protocol and uder GLP. No deviations, Klimisch rating 1.

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:
18 May 2009- 09 June 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
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
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
Positive control results:
Positive control SI = 3.2
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
Interpretation of results:
GHS criteria not met
Conclusions:
SMCA is not a skin sensitizer as SI values were below 3.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Key study is an LLNA performed with the sodium salt of MCA (3926 -62 -3), according to OECD protocol and uder GLP. No deviations, Klimisch rating 1.

A skin sensitisation study with MCA cannot be performed because of its corrosive properties. Under physiological conditions, both MCAA and SMCA exist as the monochloroacetate ion. Therefore, a study with SMCA is considered adequate and sufficient for classification purposes for MCA.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data available

Justification for classification or non-classification

Substance has no skin sensitising properties in a skin sensitisation assay; as such it is highly likely that it is neither a respiratory sensitiser.