Registration Dossier
Registration Dossier
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EC number: 931-288-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment: non-GLP, no data on purity of test substance.
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:
- N-[6-(3-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}-2,4-dioxo-1,3-diazetidin-1-yl)hexyl]formamide; N-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}formamide
- EC Number:
- 931-288-4
- Molecular formula:
- (C8H12N2O2)n
- IUPAC Name:
- N-[6-(3-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}-2,4-dioxo-1,3-diazetidin-1-yl)hexyl]formamide; N-{6-[3-(6-formamidohexyl)-2,4-dioxo-1,3-diazetidin-1-yl]hexyl}formamide
- Reference substance name:
- 28182-81-2
- Cas Number:
- 28182-81-2
- IUPAC Name:
- 28182-81-2
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co KG, Extertal, Germany
- Mean weight at study initiation: 2.7 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated opposite flank served as control
- Amount / concentration applied:
- 500 µL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examinations were terminated after 7 days, since all changes had completely subsided then.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
24 hours before testing fur was shorn with an electric clipper on both sides of the trunk.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test site was covered with a gauze patch, which was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 4 hours exposure period the patch was removed. Washing was done with water or olive oil.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: mean score: 0.7
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean score: 1.7
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: mean score: 0.7
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- >= 1 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: mean score: 1.3
Applicant's summary and conclusion
- Executive summary:
An acute dermal irritation/corrosion test was conducted according to OECD TG 404. In this study the substance elicited a very slight erythema and a very slight up to moderate oedema on 3/3 rabbits after 24, 48 and 72 hours (Mean scores at time points 24, 48, and 72 h: 0.8 for erythema, 1.2 for oedema). All effects were fully reversible after 7 days at the latest.
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