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Diss Factsheets

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
Reference
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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

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

               

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.

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.