Registration Dossier
Registration Dossier
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EC number: 219-514-3 | CAS number: 2451-62-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline followede, all data available
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 219-514-3
- EC Name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 2451-62-9
- Molecular formula:
- C12H15N3O6
- IUPAC Name:
- tris[(oxiran-2-yl)methyl]-1,3,5-triazinane-2,4,6-trione
- Reference substance name:
- 1,3,5-tris(oxiran-2-ylmethyl)-1,3,5-triazine-2,4,6-trione
- IUPAC Name:
- 1,3,5-tris(oxiran-2-ylmethyl)-1,3,5-triazine-2,4,6-trione
- Details on test material:
- TEPIC-C, sample C,
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- rabbits were 12 - 16 weeks old, with a weight of 2.24 - 2.60 kg, and kept in individual cages.
The animals rooms had 15 cycles of air per hour, a temperature of 18-23 °C, and a relative humidity of 45 - 55 %.
A 12hour dark/light cycle was applied.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.4 gm in 1 ml of water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- animals were shave on the back, and TGIC suspension was applied on an area of 2 x 2 cm, and covered with a semi-occlusive bandage for 4 hours. Reading was at 4, 24, 48, and 72 hours.
Body weight was measured daily
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No irritation observed
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- same responsed observed at 24, 48, and 72 hours (0.0)
- Other effects:
- Body weight development was similar to concurrent control animals of different study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- TEPIC-C, sample C, was not irritant to skin in the assay with rabbits when treatment was 4 hours
- Executive summary:
TEPIC-C, sample C, was not irritant to skin in the assay with rabbits when treatment was 4 hours
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