Sodium chloroacetate

Endpoint summary

Description of key information

LLNA performed with the sodium salt of MCAA, according to OECD protocol and under 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:

Study was performed according to OECD protocol under GLP, no deviations from protocol. SMCA is not a skin sensitiser

Justification for classification or non-classification

Substance has no sensitising properties in a skin sensitisation assay; as such it is likely it is no respiratory sensitizer and there no data available suggesting that it is a human respiratory sensitiser.