Registration Dossier
Registration Dossier
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EC number: 252-173-9 | CAS number: 34730-59-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium 2-[(2-aminoethyl)amino]ethanesulphonate
- EC Number:
- 252-173-9
- EC Name:
- Sodium 2-[(2-aminoethyl)amino]ethanesulphonate
- Cas Number:
- 34730-59-1
- Molecular formula:
- C4H12N2O3S.Na
- IUPAC Name:
- sodium 2-(2-aminoethylamino)ethanesulfonate
- Details on test material:
- - Composition of test material, percentage of components: 48.8 % active compound in water
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Lohndorf, 24601 Lohndorf/Post Wankendorf, Germany
- Age at study initiation: 4 - 5 months
- sex: males
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral untreated skin area of test animals served as control
- Amount / concentration applied:
- Amount: 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours, and 4 to 14 days after application
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
Classification: not irritating- Executive summary:
In a study performed according to OECD 404 the test item was shown to be slightly irritating to the skin of rabbits. No systemic intolerance reactions were observed.
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