Registration Dossier
Registration Dossier
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EC number: 219-351-8 | CAS number: 2422-91-5
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:
- 2 002
- Report date:
- 2002
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methylidynetri-p-phenylene triisocyanate
- EC Number:
- 219-351-8
- EC Name:
- Methylidynetri-p-phenylene triisocyanate
- Cas Number:
- 2422-91-5
- Molecular formula:
- C22H13N3O3
- IUPAC Name:
- 1-[bis(4-isocyanatophenyl)methyl]-4-isocyanatobenzene
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: appr. 4.5 months
- sex: males
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: surrounding untreated skin served as control
- Amount / concentration applied:
- Amount: 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours, and 4 to 13 days after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: light brown discolouration
- Basis:
- other: all 3 animals
- Time point:
- other: from patch removal up to 8 days
- Remarks on result:
- other: Due to light brown discolouration of the application area no evaluation of erythema and oedema formation was possible.
- Irritation parameter:
- other: induration
- Basis:
- animal #1
- Time point:
- other: 1 day up to 5 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: induration
- Basis:
- animal #2
- Time point:
- other: 3 up to 5 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: induration
- Basis:
- animal #3
- Time point:
- other: up to 5 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: laceration
- Basis:
- animal: #1, #3
- Time point:
- other: 6 to 9 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: laceration
- Basis:
- animal #2
- Time point:
- other: 5 to 8 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: peeling
- Basis:
- animal #1
- Time point:
- other: 10 to 12 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: peeling
- Basis:
- animal #2
- Time point:
- other: 9 to 10 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: peeling
- Basis:
- animal #3
- Time point:
- other: 10 and 11 days
- Remarks on result:
- other: see above
- Irritation parameter:
- other: erythema/oedema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 9 days to 13 days after patch removal
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Conclusions:
Classification: not irritating- Executive summary:
Triphenylmethane-4,4',4''-triisocyanate (applied as a 27% solution in ethyl acetate) was shown to be irritating to the rabbit's skin in a study performed according to OECD TG 404. Due to light brown discolouration of the application area no evaluation of erythema and oedeme formation was possible in all 3 animals from the time point of patch removal to 8 days after patch removal. Thereafter the erythema/oedema score was 0 in all animals. On the other hand induration, laceration and peeling was observed in all animals whereas the onset of the effects differ from 24 hours to 5 days after patch removal. All effects were reversible within 13days after patch removal. No systemic intolerance reactions were observed.
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