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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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%