Registration Dossier
Registration Dossier
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EC number: 226-540-9 | CAS number: 5421-46-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 Mar 2003 - 9 Mar 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
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): Ammonium thioglycolate 71%
- Physical state: colourless liquid
- Analytical purity: 71.5%
- Impurities (identity and concentrations): Iron < 0.1 ppm
- Purity test date: 14.02.2003
- Lot/batch No.: 4676
- Storage condition of test material: at room temperature and under nitrogen gas
- Other: Source: Bruno Bock Chemische Fabrik GmbH & Co KG
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.4 ± 0.1 kg
- Housing: individually in polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France) ad libitum
- Water (e.g. ad libitum): filtered drinking water ad libitum
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 71.5 % active substance - Duration of treatment / exposure:
- 3 min, 4 h
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
Since there was persistent irritation reactions at 72 hours, the observation period was extended up to their complete reversibility (day 6). - Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 3-minute exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: one animal
- Irritation parameter:
- edema score
- Remarks:
- 3-minute exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: one animal
- Irritation parameter:
- erythema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 6
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item ammonium thioglycolate 71% is slightly irritating when applied topically to rabbits.
Classification: not irritating
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