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Registration Dossier
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EC number: 226-540-9 | CAS number: 5421-46-5
Skin sensitisation
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:
- 2 001
- 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
- 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
Constituent 1
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.
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