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EC number: 700-674-2 | CAS number: 147993-65-5
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- 1-isocyanato-2-[(4-isocyanatophenyl)methyl]benzene; 1-isocyanato-4-[(4-isocyanatophenyl)methyl]benzene; 2-ethylhexyl N-(4-{[4-({[(2-ethylhexyl)oxy]carbonyl}amino)phenyl]methyl}phenyl)carbamate; 2-ethylhexyl N-{4-[(4-isocyanatophenyl)methyl]phenyl}carbamate
- EC Number:
- 700-674-2
- Cas Number:
- 147993-65-5
- Molecular formula:
- Unspecified Not applicable, since UVCB
- IUPAC Name:
- 1-isocyanato-2-[(4-isocyanatophenyl)methyl]benzene; 1-isocyanato-4-[(4-isocyanatophenyl)methyl]benzene; 2-ethylhexyl N-(4-{[4-({[(2-ethylhexyl)oxy]carbonyl}amino)phenyl]methyl}phenyl)carbamate; 2-ethylhexyl N-{4-[(4-isocyanatophenyl)methyl]phenyl}carbamate
- Test material form:
- liquid
Constituent 1
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: 2.3-3.0 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:
- unchanged (no vehicle)
- Controls:
- other: the surrounding untreated skin area of test animals served as control
- Amount / concentration applied:
- Amount: 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours as well as 7 and 14 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 water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: fully reversible within 1 day in respect of the result 1 h post application
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: fully reversible within 1 day in respect of the result 1 h post application
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no oedema observed during the study
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: fully reversible within 1 day in respect of the result 1 h post application
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: fully reversible within 1 day in respect of the result 1 h post application
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: fully reversible within 1 day in respect of the result 1 h post application
- Remarks on result:
- other: test compound could not be removed completely from skin, 24 h- 72- h and 14 d desquamation after patch removal
- Irritant / corrosive response data:
- In conjugation with the chemical properties and the fact that the test compound could not be removed completely from the skin, the most plausible explanation for the desquamation is residue of test compound adhered to the treated skin area. This was not regarded as irritation to the skin.
- 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 1 0 0 0 0 0
Oedema formation 0 0 0 0 0 0
Animal 2
Erythema (redness)
and eschar formation 1 1 1 0 0 0
Oedema formation 0 0 0 0 0 0
Animal 3
Erythema (redness)
and eschar formation 1 1 1 0 0 0
Oedema formation 0 0 0 0 0 0
- = no further examination
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- slightly irritating
- Conclusions:
Classification: not irritating- Executive summary:
In a dermal irritation/corrosion study according to OECD TG 404 Desmodur MT 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 as well as 7 and 14 days using the Draize scale. The mean irritation index for erythema was 0.5 of max. 4 (0.0 - 0.7), the mean irritation index for edema was 0.0 of max. 4. Signs were fully reversible in all animals within three days. 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 MT is not an irritant to the skin.
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