Registration Dossier
Registration Dossier
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EC number: 613-645-3 | CAS number: 646505-36-4
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate
- EC Number:
- 613-645-3
- Cas Number:
- 646505-36-4
- Molecular formula:
- see structural formula
- IUPAC Name:
- Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino rabbits, strain HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton Huntingdon, England
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 2 weeks
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, 7 and 14 days after application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: Fixomull - stretch Klebeflies, semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water without altering the existing response of the integrity of the epidermis
- 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: mean of 24, 48, 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: slight oedema (mean score: 0.3)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: slight oedema (mean score: 0.3)
- Irritant / corrosive response data:
- erythematous and exsudative reactions; in 2 animals not proved to be fully reversible within 14 days
mean irritation index calculated by averaging the total scores of all 6 rabbits: erythema and eschar formation (2.02), oedema formation (0.1) - Other effects:
- There were no systemic intolerance reactions recorded.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information
- Conclusions:
- moderately irrtating to skin
Classification: not irritating - Executive summary:
In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be an irritant to the rabbits skin. No relevant systemic intolerance reactions were observed.
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