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Registration Dossier
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EC number: 931-297-3 | CAS number: -
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:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (6E)-3,5-bis(6-isocyanatohexyl)-6-[(6-isocyanatohexyl)imino]-1,3,5-oxadiazinane-2,4-dione
- EC Number:
- 931-297-3
- Molecular formula:
- (C8H12N2O2)n
- IUPAC Name:
- (6E)-3,5-bis(6-isocyanatohexyl)-6-[(6-isocyanatohexyl)imino]-1,3,5-oxadiazinane-2,4-dione
- 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
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, 88353 Kißleg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 2.2-2.7 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 25 %
- Air changes (per hr): no data
- 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 surrounding untreated skin served as control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- Due to animal welfare reasons only one animal was initially treated with three test patches. These were successively removed: after 3 minutes, after 1 hour and the third was allowed to remain 4 hours, in each case if no serious skin reactions were observed. Completion of the test was then carried out using 2 additional animals, exposed for 4 hours.
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
On the day before the test, the fur was shorn on the right and left side from the dorso-lateral area of the trunk of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healthy and intact skin were used. 0.5 mL of the pure liquid test substance was applied to the skin of the animal under a gauze patch. The treated skin area was approximately 2.5 cm by 2.5 cm in size. The patch was placed on the dorso-lateral areas of the trunk of each animal and was held in place with non-irritating tape for the duration of the exposure period. Thus, access by the animal to the patch and resultant ingestion of the test substance was prevented.
REMOVAL OF TEST SUBSTANCE
After the exposure period the dressing and patch were removed.
- Washing (if done): The exposed skin area was carefully washed with water.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean score: 1
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Animal 2, day 7 after patch removal: desquamation.
There were no relevant systemic intolerance reactions.
Applicant's summary and conclusion
- Conclusions:
Classification: not irritating- Executive summary:
An Acute Dermal Irritation/Corrosion test was conducted with the substance according to OECD TG 404. Under the conditions of the test the substance showed no up to very slight dermal irritation (Mean score of time points 24, 48, and 72 h: 0.3 for erythema, 0 for oedema). There were no relevant systemic intolerance reactions.
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