Registration Dossier
Registration Dossier
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EC number: 200-573-9 | CAS number: 64-02-8
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetrasodium ethylenediaminetetraacetate
- EC Number:
- 200-573-9
- EC Name:
- Tetrasodium ethylenediaminetetraacetate
- Cas Number:
- 64-02-8
- Molecular formula:
- C10H16N2O8.4Na
- IUPAC Name:
- tetrasodium 2-({2-[bis(carboxylatomethyl)amino]ethyl}(carboxylatomethyl)amino)acetate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: 03370
- Impurities (identity and concentrations): 8% Na3 Ethylenediaminetriacetic acid, 1.2% Na2 Ethylenediaminetriacetic acid, 3.6% Na3 Nitriloltriacetic acid, < 0.3% Na2 iminodiacetic acid, 2.6% Na-glycolic acid, urotropin
- Expiration date of the lot/batch: April 1984
- test material contained 1.64% NaOH
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet: Ovator Solikanin; 130 g/day
- Water: tap water ca 250 mL/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: Untreated skin of the same animal
- Amount / concentration applied:
- - 0.5 g (80% in water)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2 .5 cm X 2 .5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): once with lutrol and once with lutrol/water 50%/50%
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema 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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Additionally there was a slight erythema (grade 1) in all animals 30 - 60 min after removal of TS.
- Other effects:
- No other effects
Applicant's summary and conclusion
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