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EC number: - | 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: Not a dermal irritant
Ocular Irritation: Not an ocular irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- In vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-08-11 to 2011-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Deviations of temperature and humidity (for several days during the study) were deemed to have had no adverse effects on the study animals or the integrity of the study, since all the animals gained weight normally, and were free from signs of stress based on daily observations.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Label Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 08/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Sample preparation: Te test article was used as received - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle Rabbitry Inc., Thompson Station, TN
- Received on: 10/21/10
- Date of birth: 07/20/10
{Age at study initiation 3 months 21 days - study initiation date mm/dd 11/09/2010}
- Weight at study initiation: 2.7 -3.0 kg
- Housing: suspended wire bottom cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) - daily
- Water (e.g. ad libitum): freeily available
- Acclimation period: (>5 days) - approx 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C):[ Room temperature]. Parameters deviated from the protocol for several days during the study;
- Humidity (%): Parameters deviated from the protocol for several days during the study - Deviations of temperature and humidity were deemed to have had no adverse effects on the study animals or the integrity of the study, since all the animals gained weight normally, and were free from signs of stress based on daily observations.
- Air changes (per hr): no info
- Photoperiod: 12 hr light/12 hr dark
Fresh PMI rabbit chow was priovided daily (diet #5321) and drinking water was available ad-lib. The animal room was kept clean and vermin-free.
IN-LIFE DATES:
Study initiation: 11/08/2010
Experimental start due: 11/09/2010
Experimental term data: 11/12/2010
Draft report signed: 01/07/2011
Final report signed: 03/03/2011 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site applied to a 2x3 cm gauze patch. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24, 48, 72 hours post patch removal
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 10x10
- % coverage: 3x3 cm
- Type of wrap if used: porous, not irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): ethanol (end of exposure time) prior scoring - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Dermal observations:
Well defined erythema and very slight edema was observed at 1 hour following the 4 hour exposure. At 24 and 48 hours, absent to very slight erythema and very slight edema was observed. No erythema or edema was observed at 72 hours.
Systemic Observations and Body Weights:
There were no abnormal physical signs noted during the observation period - Other effects:
- Systemic Observations and Body Weights:
There were no abnormal physical signs noted during the observation period. All body weight changes were normal. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified
- Conclusions:
- The test material Santiciser P1400 is a mild dermal irritant under the conditions of the study but does not meet the criteria for classification under EU CLP or GHS.
- Executive summary:
The test material Santicizer Platinum P1400 was investigated to determine the irritant and corrosive effects when applied dermally for 4 hours. Three New Zealand rabbits were dosed dermally with 0.5 ml of the test material, which was applied and kept in contact to one skin site for 4 hours, at which time the wrapping was removed. The skin was evaluated for edema, erythema and scored at 1, 24, 48 and 72 hr (numerical Draize technique) following the patch removal. Toxicological and pharmacological effects, body weight and mortality were also recorded.
The results of the study showed well defined erythema and very slight edema at 1hr after the 4 hour exposure. At 24 and 48 hours, slight erythema and very slight edema was observed. These effects were fully reversible in all 3 tested animals by 72 hours. No adverse clinical signs, abnormal body weight or mortality were observed during the study. In conclusion, the test material Santiciser P1400 is a mild dermal irritant but does not meet the criteria for classification under EU CLP or GHS.
Reference
Table1. Dermal Observations, Body Weights, and Systemic Observations |
|||
Rabbit Eartag |
Animal Number |
||
H3798 |
H3799 |
H3800 |
|
Sex |
Male |
Male |
Male |
Pre-test Body Weight (Kg) |
2.7 |
2.9 |
3.0 |
Terminal Body Weight (Kg) |
2.7 |
2.9 |
3.0 |
Erythema and Eschar Formation |
|||
Time after Patch Removal |
|
|
|
60 minutes |
2 |
2 |
2 |
24 hours |
0 |
1 |
1 |
48 hours |
0 |
0 |
1 |
72 hours |
0 |
0 |
0 |
Edema |
|||
60 minutes |
1 |
1 |
1 |
24 hours |
1 |
1 |
1 |
48 hours |
1 |
1 |
1 |
72 hours |
0 |
0 |
0 |
Systemic Observations |
|||
60 minutes |
A |
A |
A |
24 hours |
A |
A |
A |
48 hours |
A |
A |
A |
72 hours |
A |
A |
A |
A = Normal
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-08-11 to 2011-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Label Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 08/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Sample preparation: Te test article was used as received - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- 1 female and 2 males
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc. Thompsons, TN
- Date received: 10/21/10
- Date of birth: 07/20/10
- Weight at study initiation: 2.7 -2.8 kg
- Housing: 1/ cage in suspended cages
- Diet ( ad libitum): Fresh PMI Rabbit Chow - daily
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): This parameter deviated from the standard protocol. This did not influence the study animals and the integrity of the study.
- Humidity (%): This parameter deviated from the standard protocol. This did not influence the study animals and the integrity of the study.
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12hr /12 hr - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single 0.1 mL dose into eye
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- Three rabbits: 2 males and 1 female
- Details on study design:
- SCORING SYSTEM: see attachment
TOOL USED TO ASSESS SCORE: sodium fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Ocular finding
Treated eyes: There was no corneal opacity, iritis or conjunctival irritation at any observation period.
Control eyes: The control eyes appeared normal at all observation periods. - Other effects:
- Systemic observation
There were no abnormal physical signs noted during the observation period. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Not irritating
- Conclusions:
- Based on the lack of effects observed, It was determined that the test material Santicizer P1400 did not produce irritation to eyes and does not meet the criteria for classification as an ocular irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
- Executive summary:
In a key EPA OPPTS Guideline 870.2400 study, the potential of the test material (Santicizer P1400) to cause ocular irritation or corrosion was evaluated after instillation into the rabbit eye. 0.1 mL of the test material was placed into the conjunctival sac of one eye of three healthy New Zealand White rabbits (1 female and 2 males) with the contralateral eye serving as control. Treated and control eyes were examined pretest and scored by the Draize technique at 1, 24, 48, and 72 hours post-exposure. Sodium fluorescein dye procedures were used at the 24 hour observation interval and animals were evaluated for mortality, toxicity, and pharmacological effects at each ocular observation point. Body weights were recorded pretest.
No abnormal physical signs were observed during the study period and no corneal opacity, iritis, or conjunctival irritation was observed at any observation point. In 1 animal at the 1 hour timepoint, chemosis (1) and discharge (1), without redness (0) was observed. However, this was fully reversible by 24 hours and not considered indicative of irritation by the test material. All control eyes appeared normal through the study period.
Based on the lack of effects observed, It was determined that the test material Santicizer P1400 did not produce irritation to eyes and does not meet the criteria for classification as an ocular irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Reference
Table 1. Ocular Findings, Systemic Observations, and Body Weights |
|||||||
Animal No. / Sex |
Item |
Tissue |
Reading |
1 hour |
24 hours |
48 hours |
72 hours |
H3811 / Male |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
B |
Area |
0 |
0 |
0 |
0 |
||
|
1. Total = (A x B) x 5 |
0 |
0 |
0 |
0 |
||
C |
Iris |
|
0 |
0 |
0 |
0 |
|
|
2. Total = (C x 5) |
0 |
0 |
0 |
0 |
||
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
Chemosis |
0 |
0 |
0 |
0 |
||
F |
Discharge |
0 |
0 |
0 |
0 |
||
|
3. Total = (D+E+F) x 2 |
0 |
0 |
0 |
0 |
||
|
Total = 1+2+3 |
0 |
0 |
0 |
0 |
||
|
Systemic Observations |
A |
A |
A |
A |
||
|
Sodium Fluorescein |
|
0 |
N/A |
N/A |
||
|
Pretest Body Weight: 2.7 Kg |
|
|
|
|
||
|
|||||||
H3812 / Male |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
B |
Area |
0 |
0 |
0 |
0 |
||
|
1. Total = (A x B) x 5 |
0 |
0 |
0 |
0 |
||
C |
Iris |
|
0 |
0 |
0 |
0 |
|
|
2. Total = (C x 5) |
0 |
0 |
0 |
0 |
||
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
Chemosis |
1 |
0 |
0 |
0 |
||
F |
Discharge |
1 |
0 |
0 |
0 |
||
|
3. Total = (D+E+F) x 2 |
4 |
0 |
0 |
0 |
||
|
Total = 1+2+3 |
4 |
0 |
0 |
0 |
||
|
Systemic Observations |
A |
A |
A |
A |
||
|
Sodium Fluorescein |
|
0 |
N/A |
N/A |
||
|
Pretest Body Weight: 2.7 Kg |
|
|
|
|
||
|
|||||||
H3837 / Female |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
B |
Area |
0 |
0 |
0 |
0 |
||
|
1. Total = (A x B) x 5 |
0 |
0 |
0 |
0 |
||
C |
Iris |
|
0 |
0 |
0 |
0 |
|
|
2. Total = (C x 5) |
0 |
0 |
0 |
0 |
||
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
Chemosis |
0 |
0 |
0 |
0 |
||
F |
Discharge |
0 |
0 |
0 |
0 |
||
|
3. Total = (D+E+F) x 2 |
0 |
0 |
0 |
0 |
||
|
Total = 1+2+3 |
0 |
0 |
0 |
0 |
||
|
Systemic Observations |
A |
A |
A |
A |
||
|
Sodium Fluorescein |
|
0 |
N/A |
N/A |
||
|
Pretest Body Weight: 2.8 Kg |
|
|
|
|
A = Normal
The control eyes appeared normal at all observation points
Table 2. Mean scores (EU and GHS) |
||||
Time Points |
24 hours |
48 hours |
72 hours |
Mean |
Animal Number / Sex |
H3811 / Male |
|||
Corneal Opacity |
0 |
0 |
0 |
0.0 |
Iritis |
0 |
0 |
0 |
0.0 |
Conjunctival Redness |
0 |
0 |
0 |
0.0 |
Conjunctival Edema (chemosis) |
0 |
0 |
0 |
0.0 |
|
||||
Animal Number / Sex |
H3812 / Male |
|||
Corneal Opacity |
0 |
0 |
0 |
0.0 |
Iritis |
0 |
0 |
0 |
0.0 |
Conjunctival Redness |
0 |
0 |
0 |
0.0 |
Conjunctival Edema (chemosis) |
0 |
0 |
0 |
0.0 |
|
||||
Animal Number / Sex |
H3837 / Female |
|||
Corneal Opacity |
0 |
0 |
0 |
0.0 |
Iritis |
0 |
0 |
0 |
0.0 |
Conjunctival Redness |
0 |
0 |
0 |
0.0 |
Conjunctival Edema (chemosis) |
0 |
0 |
0 |
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
The test material Santicizer Platinum P1400 was investigated to determine the irritant and corrosive effects when applied dermally for 4 hours (MB Research Laboratories, 2011c). Three New Zealand rabbits were dosed dermally with 0.5 ml of the test material, which was applied and kept in contact to one skin site for 4 hours, at which time the wrapping was removed. The skin was evaluated for edema, erythema and scored at 1, 24, 48 and 72 hr (numerical Draize technique) following the patch removal. Toxicological and pharmacological effects, body weight and mortality were also recorded.
The results of the study showed well defined erythema and very slight edema at 1hr after the 4 hour exposure. At 24 and 48 hours, slight erythema and very slight edema was observed. These effects were fully reversible in all 3 tested animals by 72 hours. No adverse clinical signs, abnormal body weight or mortality were observed during the study. In conclusion, the test material Santiciser P1400 is a mild dermal irritant but does not meet the criteria for classification under EU CLP or GHS.
Based on the lack of effects observed, it was determined that the test material Santicizer P1400 does not meet the criteria for classification as a dermal irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Eye Irritation
In a key read across EPA OPPTS Guideline 870.2400 study, the potential of the test material (Santicizer P1400) to cause ocular irritation or corrosion was evaluated after instillation into the rabbit eye (MB Research Laboratories, 2011d). 0.1 mL of the test material was placed into the conjunctival sac of one eye of three healthy New Zealand White rabbits (1 female and 2 males) with the contralateral eye serving as control. Treated and control eyes were examined pretest and scored by the Draize technique at 1, 24, 48, and 72 hours post-exposure. Sodium fluorescein dye procedures were used at the 24 hour observation interval and animals were evaluated for mortality, toxicity, and pharmacological effects at each ocular observation point. Body weights were recorded pretest.
No abnormal physical signs were observed during the study period and no corneal opacity, iritis, or conjunctival irritation was observed at any observation point. In 1 animal at the 1 hour timepoint, chemosis (1) and discharge (1), without redness (0) was observed. However, this was fully reversible by 24 hours and not considered indicative of irritation by the test material. All control eyes appeared normal through the study period.
Based on the lack of effects observed, it was determined that the test material Santicizer P1400 did not produce irritation to eyes anddoes not meet the criteria for classification as an ocular irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Justification for classification or non-classification
P1400 does not meet the criteria for classification as a dermal or ocular irritant under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.