Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 245-904-8 | CAS number: 23843-64-3
- 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 (OECD 404), rabbit: not irritating
Eye irritation (OECD 405), rabbit: not 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
- Study period:
- 05 Feb - 28 June 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- no data on purity available
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2739 - 2903 g
- Fasting period before study: no
- Housing: individually housed in wire-mesh cages
- Diet: Purina Certified Rabbit Chow No. 5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-20.4
- Humidity (%): 34.7-60.2
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
Reading time points: 1, 24, 48 and 72 h and 4, 5, 6, 7 and 8 days - Number of animals:
- 6 (2 males, 4 females)
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: test substance was applied under a secured 2-ply gauze patch overwrapped with a gauze binder and secured with Dermiform tape
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the treatment period the sites were wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No oedema reactions were observed in any animal at any time point. After 0.5-1 h no erythema reactions were observed. After 24 h 2/6 animals showed erythema (grade 1), which were fully reversible within 7 days. In addition, in the 2 animals with erythema reactions desquamation was observed from Day 3 until Day 7.
- Other effects:
- No deaths, clinical signs of toxicity or body weight changes were observed throughout the study period.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a skin irritation study according to OECD 404 the test item was found to be not irritating to skin. Treatment of 6 New Zealand White rabbits under semi-occlusive conditions with 0.5 ml undiluted test substance induced no edema in any animal at any time point. Slight erythema (grade 1) were observed in 2/6 animals but were fully reversible within 7 days. Furthermore no signs of systemic toxicity no effects on body weight were observed.
Reference
Table 1: Individual scores from skin irritation study in rabbits.
Rabbit No. |
1 (male) |
2 (male) |
3 (female) |
4 (female) |
5 (female) |
6 (female) |
||||||
Observation time |
Ery. |
Oed. |
Ery. |
Oed. |
Ery. |
Oed. |
Ery. |
Oed. |
Ery. |
Oed. |
Ery. |
Oed. |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
1d |
0 |
0 |
0 |
1d |
0 |
0 |
0 |
0 |
0 |
4 d |
- |
- |
1d |
0 |
- |
- |
1d |
0 |
- |
- |
- |
- |
7 d |
- |
- |
0 |
0 |
- |
- |
0d |
0 |
- |
- |
- |
- |
8 d |
- |
- |
- |
- |
- |
- |
0 |
0 |
- |
- |
- |
- |
Mean value |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
24 + 48 + 72 h |
Ery.: Erythema
Oed.: Oedema
d: Desquamation
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:
- 05 Feb - 28 June 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data on purity available
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2425 - 3073 g
- Fasting period before study: no
- Housing: individually housed in mesh-bottom cages
- Diet: Purina Certified Rabbit Chow No. 5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8-20.2
- Humidity (%): 35.0-42.6
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml - Duration of treatment / exposure:
- single instillation without washing
- Observation period (in vivo):
- 4 days
Reading time points: 1, 24, 48 and 72 h and 4 days - Number of animals or in vitro replicates:
- 6 (3 males, 3 females)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-held penlight / fluorescein (UV light) - Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects on cornea or iris were observed in any animal at any time point. Slight conjuntivae redness (grade 1-2) was observed in every animal 1 h after instillation of test item and were fully reversible within 4 days. Chemosis (grade 1) was observed in every animal 1 h after instillation of test substance and was fully reversible within 48 h. Clear discharge was observed in 1 animal 1 h after instillation of test substance but was fully reversible within 24 h.
- Other effects:
- No signs of systemic toxicity or effects on body weight gain were observed.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In an eye irritation study according to OECD 405 the substance was found to be not irritating to eyes. Treatment of 3 female and 3 male New Zealand White rabbits with 0.1 ml undiluted test substance resulted in no effects on cornea and iris in any animal at any time point. Slight conjuntivae redness (grade 1-2) was observed in every animal 1 h after instillation of test item and were fully reversible within 4 days. Chemosis (grade 1) was observed in every animal 1 h after instillation of test substance and was fully reversible within 48 h. Clear discharge was observed in 1 animal 1 h after instillation of test substance but was fully reversible within 24 h.
Reference
Table 1: Individual scores from eye irritation study in male rabbits.
Rabbit # (males) |
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.33 |
0 |
0 |
0 |
|
2
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
1.00 |
0 |
0 |
0 |
|
3
|
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
1.00 |
0 |
0 |
0 |
|
|
Table 2: Individual scores from eye irritation study in female
rabbits.
Rabbit # (females) |
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.33 |
0 |
0 |
0 |
|
2
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.33 |
0 |
0 |
0 |
|
3
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
0.66 |
0.33 |
0 |
0 |
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A skin irritation study with 1-[3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3) is available and was performed according to OECD 404 and in compliance with GLP (WIL, 1996c). In the study four female and two male New Zealand White rabbits were exposed to 0.5 ml of the neat test material applied onto the clipped skin via semi-occlusive dressing for 4 hours. Skin reactions were evaluated 1, 24, 48 and 72 hours as well as 4, 7 and 8 days after removal of the test substance. No edema reactions were observed in any animal at any time point. After 0.5 - 1 h no erythema reactions were observed. After 24 h 2/6 animals showed erythema (grade 1), which were fully reversible within 7 days. In addition, in the 2 animals with erythema reactions desquamation was observed from day 3 until day 7. Mean values for erythema and edema were 0.33 and 0, respectively. No mortalities occurred and no remarkable body weight changes as well as clinical signs of toxicity were observed during the study period. Based on the study results and according to CLP classification criteria, the test substance is not considered to be irritating to skin.
Eye irritation
An eye irritation study with 1-[3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3) is available and was performed according to OECD 405 and in compliance with GLP (WIL, 1996d). For the assessment of the eye irritation properties 0.1 ml of the test substance was instilled in the eye of three New Zealand White rabbits of each sex. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours and on Day 4 post-application. No effects on cornea or iris were observed in any animal at any time point. Slight conjunctivae redness (grade 1-2) was observed in all animals 1 h after instillation of test substance but were fully reversible within 4 days. Chemosis (grade 1) was observed in all animals 1 h after instillation of the test substance but was fully reversible within 48 h. Clear discharge was observed in one animal 1 h after instillation of test substance but was also fully reversible within 24 h. Mean values for conjunctivae and chemosis over all 6 animals were 0.61 and 0.06, respectively. No signs of systemic toxicity or effects on body weight gain were observed. Based on the study results and according to CLP classification criteria, the test substance is not considered to be irritating to eyes.
Justification for classification or non-classification
The available data on skin and eye irritation of the registered substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008 and are therefore conclusive but not sufficient for classification.
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.