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EC number: 938-708-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin irritation (rabbit): slightly irritating
Eye irritation (rabbit): slightly irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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)
- 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 - 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 - 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.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: 2.6-2.8 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one untreated eye of test animals served as control
- Amount / concentration applied:
- Amount: 0.1 g
- Duration of treatment / exposure:
- The treated eye was rinsed approximately 1 hour following instillation.
- Observation period (in vivo):
- 1, 24, 48, 72 hours post application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed approximately 1 hour following instillation with 0.9 % saline
SCORING SYSTEM: according to DRAIZE - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day in respect of the result 1 hour post application
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- chemosis 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:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day in respect of the result 1 hour post application
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: mean score after 72 hours: 1.0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day in respect of the result 1 hour post application
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day in respect of the result 1 hour post application
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 1 day in respect of the result 1 hour post application
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day in respect of the result 1 hour post application
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
Classification: not irritating- Executive summary:
In an eye irritation study according to OECD TG 405 Desmodur RC/100 was instilled into the conjunctival sac of one eye of 3 female rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study Desmodur RC/100 shows slight irritant effects (mean irritation index for redness conjunctivae = 0.5 of max. 3) which were fully reversible within 3 days. No irritation effects were seen at cornea or iris 24 hours after instillation. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the eyes". No systemic intolerance reactions were observed.
According to classification criteria Desmodur RC/100 is not an irritant to the eyes.
Reference
Table 1: Summary of irritant effects on the eye
Observation time 1h
24h 48h 72h day7 day14 day21
Animal 1
Degree of cornea opacity 2 0 0 0 - - -
Area of cornea opacity 4 0 0 0 - - -
Iris 0 0 0 0 - - -
Redness conjunctivae 2 1 0 0 - - -
Chemosis conjunctivae 0 0 0 0 - - -
Animal 2
Degree of cornea opacity 2 0 0 0 - - -
Area of cornea opacity 4 0 0 0 - - -
Iris 0 0 0 0 - - -
Redness conjunctivae 2 2 1 0 - - -
Chemosis conjunctivae 1 0 0 0 - - -
Animal 3
Degree of cornea opacity 2 0 0 0 - - -
Area of cornea opacity 4 0 0 0 - - -
Iris 1 0 0 0 - - -
Redness conjunctivae 2 1 0 0 - - -
Chemosis conjunctivae 1 0 0 0 - - -
- = no further examination
Animal 1,2 and 3 (1hour p.a.): test compound adhered to cornea and conjunctiva
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
Desmodur RC/100 (TDI Trimer) was slightly irritating to the skin of rabbits according to OECD TG 404 (Gmelin, 2010a). All signs were fully reversible within one week. No relevant systemic intolerance reactions were observed. In addition, tests using an artificial 3D-Skin model revealed neither corrosive (OECD TG 431) nor irritating (EU Method B.46) properties of the test substance in vitro (Wingenroth, 2011a,b).
According to GHS classification criteria Desmodur RC/100 (TDI Trimer) is not an irritant to the skin.
Eye irritation
Desmodur RC/100 (TDI Trimer) was slightly irritating to the eyes of rabbits according to OECD TG 405 (Gmelin, 2010b). In all animals redness of conjunctivae were fully reversible within 3 days. No systemic intolerance reactions were observed. In addition, the test substance was identified as "non-irritant" to the chorioallantoic membrane (irritation score (IS) = 0) in the in vitro HET-CAM test according to a protocol recommended by ICCVAM, Nov. 2006 (Wingenroth, 2011c).
According to classification criteria Desmodur RC/100 (TDI Trimer) is not an irritant to the eyes.
Respiratory irritation
In a subacute (4-week) inhalation toxicity study in rats with a liquid aerosol (OECD TG 412) Desmodur RC (25% in ethyl acetate) (TDI Trimer) revealed no signs of particle-induced irritation of the respiratory tract (Pauluhn, 2012). The effects observed appear to be related to the physiological removal and clearance of the inhaled aerosolized test article and its reaction products with biopolymers of the proteins contained in the fluids lining the respiratory tract. Overall, the changes observed appear to be predominated by (over-) dosed alveolar macrophages by the test article itself or its polymerized reaction products.Justification for selection of skin irritation / corrosion endpoint:
Only one key study available
Justification for selection of eye irritation endpoint:
Only one key study available
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Based on the study results (slightly irritating to skin and eyes) a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.
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