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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:
27 Apr 2000 - 22 May 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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:
Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium mercaptoacetate
EC Number:
226-540-9
EC Name:
Ammonium mercaptoacetate
Cas Number:
5421-46-5
Molecular formula:
C2H4O2S.H3N
IUPAC Name:
ammonium 2-sulfanylacetate
Details on test material:
- Name of test material (as cited in study report): Ammoniumthiogycolate
- Physical state: transparent, colourless liquid
- Analytical purity: no data
- Composition of test material, percentage of components: 70% Ammoniumthioglycolate in water
- Purity test date: 28.01.2000
- Lot/batch No.: B00S5236
- Storage condition of test material: at room temperature, protected from light
- Other: Source: Bruno Bock Chemische Fabrik GmbH & Co KG

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: 8 - 12 weeks
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
other: modified acetone/aqua/olive oil (AAOO): Acetone/Aqua (1:1 v/v) = AA; AA/Olive Oil (4:1 v/v) = AAOO
Concentration:
0.5, 8, 20%
No. of animals per dose:
5
Positive control substance(s):
other: P-Phenylenediamine (CAS 106-50-3) 1% in AAOO

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
EC3
Remarks:
%
Value:
0.65
Test group / Remarks:
derived by linear interpolation
Parameter:
SI
Value:
2.7
Test group / Remarks:
0.5% ATG
Parameter:
SI
Value:
17
Test group / Remarks:
8% ATG
Parameter:
SI
Test group / Remarks:
20% ATG
Remarks on result:
not determinable
Remarks:
mortality
Parameter:
SI
Value:
5.3
Test group / Remarks:
positive control

Any other information on results incl. tables

Evaluation for the 20% concentration was not possible as all animals died after the third application, indicating systemic effects at his concentration. The EC3 value (derived by linear interpolation) was 0.65%.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Considering the reported data of this sensitization test it can be stated that the test item up from a concentration of 0.65% caused reactions identified as sensitization, as the stimulation index was equal to or greater than 3.0.
Based on an EC3 of 0.65%, ATG is regarded as strong skin sensitizer (Skin Sens 1A) in the mouse LLNA. However, patch tests in humans have shown that ATG is of lesser sensitising potency in humans than GMT, which is Skin Sens 1B.