Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 690-928-8 | CAS number: 39992-90-0
Endpoint summary
Administrative data
Description of key information
Due to structural similarities of TDI- and IPDI-Urone the irritating and corrosive potential of IPDI-Urone (39992 -90 -0) was assessed by read-across with TDI-Urone (17526 -94 -2).
OECD studies show that the substance isn't dangerous.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- TDI-Uron is used as read across partner because it is structural analog to IPDI-Uron.
For detailed justification, please see attached report in section 13.2. - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item TDI-Urone is not considered to be irritating. As IPDI-Uron is structural analogue the result is considered to be the same.
- Executive summary:
The test item TDI-Urone is not considered to be irritating. As IPDI-Uron is structural analogue the result is considered to be the same.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-02 to 2001-04-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N" (4-Methyl-m-phenylen)bis(N',N'-dimethylharnstoff)
- Substance type: organic
- Physical state: odourless solid
- Analytical purity: 100%
- Lot/batch No.: 0232 07
- Expiration date of the lot/batch: March 2003
- Stability under test conditions: stable at dry storage conditions for at least 2 years
- Storage condition of test material: store sry in closed containers - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen.
- Age at study initiation:
- Weight at study initiation:
- Housing: semi-barrier in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/-3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated other side of the dorsal area served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- Animals were observed for 72 hours after dosing
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: no data
- Type of wrap if used: gauze patch, held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using water
- Time after start of exposure: 4 h
SCORING SYSTEM: see table 1 in "Any other information on materials and methods" - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- no other effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item TDI-Urone is not considered to be irritating.
- Executive summary:
In a primary dermal irritation study according to OECD 404 three female New Zealand White Rabbits Crl:KBL (NZW) BR. were dermally exposed to 0.5 g of TDI-Urone for 4 hours to approximate 6 cm² of the skin on one side of the dorsal area. Animals then were observed for 3 days. The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period. Therefore, TDI-Urone is not irritating to the skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
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
- Study period:
- 2001-04-16 to 2001-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N"(4-Methyl-m-phenylen)bis(N',N'dimethylharnstoff)
- Substance type: organic
- Physical state: colourless solid
- Analytical purity:100%
- Purity test date: 01 March 2000
- Lot/batch No.: 023207
- Expiration date of the lot/batch: March 2003
- Storage condition of test material: store dry in closed containers
- Other: stable at dry storage conditions for at least 2 years - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: no data
- Weight at study initiation: 4.7 kg, 4.3 kg, 3.0 kg
- Housing: Serni-barrier in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 55+/-10%
- Air changes (per hr): at 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
The properly grind test item was used as delivered by the sponsor. - Duration of treatment / exposure:
- as long as observation period. The eyes were not washed after treatment.
- Observation period (in vivo):
- Animals were observed 72 h respectively and furthermore until the disappea rance ofthe symptoms. This was achieved at 48 h for animal No 375, at 96 h ofanimal No 358 and at 192 h for animal No 357.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: At the end of the observation period the eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo®, Lot H 901). - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 144 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 1 - ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 192 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- On the basis of the results it is concluded that TDI-Urone is slightly irritating to the eyes of rabbits but not relevant for classification.
- Executive summary:
In a primary eye irritation study according to OECD 405 0.1 g TDI-Urone were applied unchanged into the conjunctival sac of 3 female New Zealand White rabbits (Crl:KBL (NZW) BR). Eyes were not washed after treatment. Animals were observed 72 h respectively and furthermore until the disappearance of the symptoms. This was achieved at 48 h for animal No 375, at 96 h of animal No 358 and at 192 h for animal No 357. Irritation was scored by the method of Draize.
The test item produced redness of the conjunctivae in all three animals as well as opacity of the comea in one animal. Effects were fully reversible.
No comeal lesions were found upon fluorescein examination at the final readings.
In this study TDI-Urone was found to be slightly irritating to the eyes of rabbits but not relevant for classification.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2001-04-16 to 2001-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- TDI-Uron is used as read across partner because it is structural analog to IPDI-Uron.
For detailed justification, please see attached report in section 13.2. - Reason / purpose for cross-reference:
- read-across source
- Number of animals or in vitro replicates:
- 3 females
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 144 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 1 - ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 192 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- On the basis of the results it is concluded that IPDI-Urone is slightly irritating to the eyes of rabbits but not relevant for classification.
- Executive summary:
.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Table 1: Individual eye irritation scores
Animal number |
Hour p.a. |
Cornea |
Iris |
Conjunctivae |
||
A |
B |
C |
||||
T/C |
T/C |
T/C |
T/C |
T/C |
||
357 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
1/0 |
0/0 |
2/0 |
0/0 |
0/0 |
|
72 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
120 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
144 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
168 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
192 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
358 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
375 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
T=Test, C=Control; A=Redness; B=Chemosis; C=Discharge;
marked figures=used for calculation
Table 1: Individual eye irritation scores
Animal number |
Hour p.a. |
Cornea |
Iris |
Conjunctivae |
||
A |
B |
C |
||||
T/C |
T/C |
T/C |
T/C |
T/C |
||
357 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
1/0 |
0/0 |
2/0 |
0/0 |
0/0 |
|
72 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
120 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
144 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
168 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
192 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
358 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
375 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
T=Test, C=Control; A=Redness; B=Chemosis; C=Discharge;
marked figures=used for calculation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Based on the read-across data of TDI-Urone (17526 -94 -2) IPDI-Urone (39992 -90 -0) is not classified as skin irritant according to the CLP-regulation.
It may probably be sligthtly irritant to eyes with no releveance for classification (GHS Cat. 2B).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
