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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:
2003-09-29 - 2003-12-16
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Dept. of Health, UK
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
(2-hydroxyethyl)ammonium mercaptoacetate
EC Number:
204-815-4
EC Name:
(2-hydroxyethyl)ammonium mercaptoacetate
Cas Number:
126-97-6
Molecular formula:
C2H7NO.C2H4O2S
IUPAC Name:
2-hydroxyethan-1-aminium 2-sulfanylacetate
Constituent 2
Reference substance name:
MEATG
IUPAC Name:
MEATG
Test material form:
solid - liquid: suspension
Details on test material:
- Batch No. 5156
- Content: 83.5% MEATG in water

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
The test substance was initially applied as 0.25%, 0.5% or 1.0% w/v preparation in propylene glycol. Further groups of animals were subsequently doses with 2.5%, 5%, 10%, 10% or 25% w/v preparations in propylene glycol.
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
EC3
Value:
12.6
Test group / Remarks:
linear interpolation between 10 and 25%
Parameter:
SI
Value:
0.93
Test group / Remarks:
5%
Parameter:
SI
Value:
2.39
Test group / Remarks:
10%
Parameter:
SI
Value:
5.89
Test group / Remarks:
25%

Any other information on results incl. tables

A sample of MeaTG 83% was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines the level of T lymphocyte proliferation in the lymph nodes draining the site of chemical application, by measuring the amount of radiolabelled thymidine incorporated into the dividing cells.


 


























































































Concentration of test substance (% w/v)



Number of lymph nodes assayed



Disintegrations per minute (dpm)



dpm per lymph node



Test control ratio



0 (vehicle only)



8



1910



2.39



 N/A



0.25



8



3111



3.89



1.63



0.5



8



1648



2.06



0.86



1.0



8



2261



2.83



1.18



0 (vehicle only)



8



4362



5.45



N/A



2.5



8



4865



6.08



1.12



5



8



4039



5.05



0.93



10



8



2315



2.89



0.53



0 (vehicle only)



8



4468



5.59



 N/A



10



8



10676



13.35



2.39



25



8



26317



32.90



5.89



N/A: not applicable


The test substance was shown to have the capacity to cause skin sensitisation when applied as a 25% w/v preparation in propylene glycol. In conclusion, MeaTG 83% is a skin sensitiser.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
MeaTG 83% is a moderate skin sensitiser with an EC3 of 12.6%