Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Description of key information

Ammonium thioglycolate 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.

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:
27 Apr 2000 - 22 May 2000
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
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik
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: 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
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
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

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%.

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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Experiences in humans confirmed the sensitizing potential of thioglycolates in general.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on sufficient animal and human data, ATG can be classified as:


Skin Sens. 1B. H317. May cause an allergic skin reaction.