Registration Dossier
Registration Dossier
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EC number: 938-708-5 | 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(methyl-m-phenylene) isocyanate
- EC Number:
- 247-840-6
- EC Name:
- (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(methyl-m-phenylene) isocyanate
- Cas Number:
- 26603-40-7
- Molecular formula:
- C27H18N6O6
- IUPAC Name:
- 1,3,5-tris(3-isocyanato-4-methylphenyl)-1,3,5-triazinane-2,4,6-trione
- Reference substance name:
- TDI Trimer
- IUPAC Name:
- TDI Trimer
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, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 3.5-3.6 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with corn oil
- Controls:
- other: 0.5 ml corn oil was applied as control on the conlateral skin area
- Amount / concentration applied:
- Amount: 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours as well as 7 days after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with corn oil
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema 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 after 72 hours: 1.7
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: mean score after 72 hours: 0.7
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: mean score after 72 hours: 0.7
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Other effects:
- No systemic intolerance reactions were observed.
Any other information on results incl. tables
Table 1: Summary of irritant effects on the skin (Exposure: 4 hours)
Observation time 1h 24h 48h 72h day7 day14
(after patch removal)
Animal 1
Erythema (redness)
and eschar formation 0 2 2 1 0 -
Oedema formation 0 0 0 0 0 -
Animal 2
Erythema (redness)
and eschar formation 0 1 1 0 - -
Oedema formation 0 0 0 0 - -
Animal 3
Erythema (redness)
and eschar formation 0 1 1 0 - -
Oedema formation 0 0 0 0 - -
- = no further examination
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
Classification: not irritating- Executive summary:
In a dermal irritation/corrosion study according to OECD TG 404 Desmodur RC/100 was applied under semiocclusive dressings for 4 hours to the shaved skin of 3 female rabbits. Skin irritation was assessed after 1, 24, 48, 72 hours and 7 days using the Draize scale. The mean irritation index for erythema was 1.0 of max. 4 (0.7 -1.7), the mean irritation index for edema was 0.0 of max. 4. Signs were fully reversible in all animals within one week. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the skin". No relevant systemic intolerance reactions were observed.
According to classification criteria Desmodur RC/100 is not an irritant to the skin.
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