Registration Dossier
Registration Dossier
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EC number: 250-264-8 | CAS number: 30618-84-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17-Mar-2009 - 16-Apr-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit
Test material
- Reference substance name:
- Mercaptoacetic acid, monoester with propane-1,2,3-triol
- EC Number:
- 250-264-8
- EC Name:
- Mercaptoacetic acid, monoester with propane-1,2,3-triol
- Cas Number:
- 30618-84-9
- Molecular formula:
- C5H10O4S
- IUPAC Name:
- 2,3-dihydroxypropyl 2-sulfanylacetate
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Glyceryl Thioglycolate 80 %
- Analytical purity: 80.8 % (iodometric, based on mercaptogroup, calculated for Glycerylmonothioglycolate)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Sex: 3 females
- Age at study initiation: no data
- Weight at study initiation: > 2 kg
- Housing: Semi-barrier in an air-conditioned room
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 X / h
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 mL per test site
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 females rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The test item was applied first to a gauze patch at a single dose. The patch was then applied to the skin on a small area on the left side of the dorsal area. The gauze was held in place with non-irritating tape. The untreated right side served as control. The patch was fixed with a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test item showed neither irritant nor corrosive effects on the intact skin of 3 female rabbits after a contact time of 4 hours.
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
There were no significant bodyweight changes during the contact and observation period .
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Single application of 0.5 mL of GMT to 3 female rabbits showed neither irritating nor corrosive effects. According to GHS GMT has not to be classified.
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