Registration Dossier
Registration Dossier
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EC number: 204-815-4 | CAS number: 126-97-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-03-2003 - 06-08-2003
- 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:
- (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
- Reference substance name:
- MEATG
- IUPAC Name:
- MEATG
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Physical state: colourless liquid
- Content: 83.4%
- Lot/batch No.: 4677
- Storage condition of test material: at room temperature and under nitrogen gas
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.5 ± 0.2 kg
- Food and water: ad libitum
Environmental conditions:
- Acclimation period:at least 5 days
- 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:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 mL
- 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
- Irritation parameter:
- edema score
- Remarks:
- 3-minute exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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 4
- 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:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 6
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Dryness of the skin at day 6
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under experimental conditions, the test item MEATG 83% is slightly irritant when applied topically to rabbits.
- Executive summary:
After a 3-minute exposure (one animal), no cutaneous reactions were observed.
After a 4-hour exposure (three animals), a very slight erythema (grade 1) was noted in all animals on day 1 and persisted in two of them until day 4 (one animal) or day 6 (one animal). Dryness of the skin was recorded in 1/3 animals between on day 6.
Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.0 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema.
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