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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
ACUTE ORAL
The potential for oral acute toxicity of the test material Santicizer Platinum P1400 was determined according the OECD 423 and OPPTT 870.1000 Testing Guidelines.
Three males and three females Sprague Dawley were dosed orally with 2000 mg/kg of Santicizer Platinum P1400. The single dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle.
The animals were observed for mortality, body weight changes, general toxicity and pharmacological effects. All animals survived until the end of the treatment. No abnormal physical signs nor changes in body weights related to the treatment were observed. The gross pathology were normal. Based on the results of this study, the LD50 was considered to be greater than 2000 mg/kg bw.
ACUTE DERMAL
The test article Santicizer Platinum P1400 was applied dermally to five male and female rabbits. The test material was kept in contact with the scin for 24 hours (semi- occlusive patch). The test sites were scored for dermal irritation at 24 hours post dose and on day 14 using numerical Draize scoring code below. The skin was evaluated for ulceration, necrosis and tissue destruction. Mortality, body weights, toxicit, pharmacologic effects were recorded. The results of the study showed incidence of few faces in two males and one female with soiling of the angemital area on day 14. Erythema was slight to well denined with very slight to sligh edema at 24 hours and by day 14 no erytthema was observed. The body weights were normal as well as the necropsy results. Based on the result of this study, the acute dermal toxicity LD50 of the test material Santicizer Platinum P 1400 is greater than 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Identity: Santicizer Platinum P-1400
Batch:: RP-620
Supplier: Ferro Corporation
Date Received: 19 August 2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Specific gravity: 1.05
Sample Preparation: Used as received - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA on 11/09/10
- Age at study initiation: Born on 09/14/10
- Weight at study initiation: 179-184 grams for males and 291-324 for females
- Fasting period before study: 16-20 hours prior dosing
- Housing: suspended wire cages
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet#5012) was freely available except for 16-20 hours prior dosing
- Water (e.g. ad libitum): freely available
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): parameters deviated from protocol - not adverse effect on the study animals or the integrity of the study
- Humidity (%): parameters deviated from protocol - not adverse effect on the study animals or the integrity of the study
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark
TEST DATES:
Study initiation: 08 November 2010
Experimental Start Date: 17 November 2010
Experiment Term date: 06 December 2010
Draft Report Signed: 06 January 2011
Final Report Signed: 03 March 2011 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg
- The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. - Doses:
- 1 single dose: 2000 mg/kg
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: half hr, 1, 2, 3 hr post dose and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects - Statistics:
- Not available
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the 2000 mg/kg oral dose
- Clinical signs:
- other: No abnormal physical signs were observed during the treatment
- Gross pathology:
- No effects
- Other findings:
- No additional observations
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results observed, the LD50 of the test material Santicizer Platinum P1400 was determined to be greater than 2000 mg/Kg body weight in rats.
- Executive summary:
The potential for oral acute toxicity of the test material Santicizer Platinum P1400 was determined according the OECD 423 and OPPTS 870.1000 Testing Guidelines. Three males and three females Sprague Dawley were dosed orally with 2000 mg/Kg of Santicizer Platinum P1400. The single dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle.
The animals were observed for mortality, body weight changes, general toxicity and pharmacological effects. All animals survived until the end of the treatment. No abnormal physical signs nor changes in body weights related to the treatment were observed. The gross pathology were normal. Based on the results of this study, the LD50 was considered to be greater than 2000 mg/Kg bw.
Reference
Table 1. Body Weights and Dose Volume |
||||||
Animal No. |
Sex |
Dose Volume (mL) |
Body Weight (g) |
|||
Day 0 |
Day 7 |
Day 14 |
||||
1 |
Female |
0.34 |
179 |
246 |
262 |
|
2 |
Female |
0.34 |
180 |
238 |
265 |
|
3 |
Female |
0.35 |
184 |
243 |
277 |
|
Mean |
181 |
242 |
268 |
|||
S.D. |
2.6 |
4.0 |
7.9 |
|||
# |
3 |
3 |
3 |
|||
|
||||||
4 |
Male |
0.61 |
320 |
384 |
418 |
|
5 |
Male |
0.62 |
324 |
399 |
437 |
|
6 |
Male |
0.55 |
291 |
363 |
398 |
|
Mean |
312 |
382 |
418 |
|||
S.D. |
18.0 |
18.1 |
19.5 |
|||
# |
3 |
3 |
3 |
Table 2. Necropsy Observations |
||||||
Animal Number |
1 |
2 |
3 |
4 |
5 |
6 |
Sex |
Female |
Female |
Female |
Male |
Male |
Male |
Death (D) / Sacrifice (S) |
S |
S |
S |
S |
S |
|
Observation |
|
|
||||
Appeared normal / No findings |
X |
X |
X |
X |
X |
X |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Adequate
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Due to the physicochemical properties, exposure by inhalation is absent.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Due to the physicochemical properties, exposure by inhalation is absent.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 09/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Specific gravity: 1.05
Sample Preparation: The test article was used as received
TEST DATES:
Study Initiation: 08 November 2010
Experimental Start Date: 10 November 2010
Experimental Term Date: 24 November 2010
Draft Report Signed: 07 January 2011
FInal Report Signed: 03 March 2011 - Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry Incorporated, Thompson Statio, TN
- Received on: 10/21/10
- Date of birdh: 07/20/10
- Weight at study initiation: 2.4-2.9 Kg for males and 2.8-3.0 Kg for females
- Housing: 1/cage in suspended cages
- Diet (e.g. ad libitum): PMI Rabbit Chow - daily
- Water (e.g. ad libitum): freely available
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): parameters deviated from protocol - no adverse effect on the study animals or the integrity of the study
- Humidity (%): parameters deviated from protocol - no adverse effect on the study animals or the integrity of the study
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light - Type of coverage:
- semiocclusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10x15 cm
- % coverage: 10%
- Type of wrap if used: piece of porous dressing (semi occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water distillated
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- Single Dose of 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 4 hours post dosing and once daily until Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity, pharmacological effects, gross pathology - Statistics:
- An estimate of the LD50 was made based on the mortality occurring during the study.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the end of the study.
- Clinical signs:
- other: Few feces were observed in two males and one female was observed with soiling of the anogenital area on day 14. No other observation.
- Gross pathology:
- Necropsy did not reveal any treatment-related changes.
- Other findings:
- Erythema was slight to well defined with very slight to slight edema at 24 hours and by day 14 there was no erythema or edema observed.
- Interpretation of results:
- other: Not classified
- Conclusions:
- Based on the results observed, the dermal LD50 of Santicizer P1400 was determined to be greater than 2000 mg/Kg of body weight in rabbits. According to GHS Classification, Santicizer P1400 meets the criteria to be classified as Acute Toxic Category 5.
- Executive summary:
A key EPA Guideline OPPTS 870.1200 study was conducted to determine the potential for toxicity of the test material (Santicizer P1400) when applied dermally. Five male and five female New Zealand White rabbits were dosed dermally with Santicizer P1400 at 2000 mg/Kg of body weight. The test material was kept in contact with the skin for 24 hours and dermal responses recorded at 24 hours post exposure and on Day 14. Animals were observed for toxicity, mortality and pharmacological effects at 1 and 4 hours post exposure and once daily for 14 days. Body weights were recorded pretest, weekly and at termination and all animals were examined for gross pathology.
No mortality was observed through the study period. Incidences of few faeces were observed in two males while one female was observed to have soiling of the anogenital area on Day 14. No other physical signs were observed. At 24 hours post exposure, erythema was slight to well-defined and edema was very slight to slight. By Day 14, no erythema or edema was observed. Body weight changes in all animals in both sexes appeared normal and gross necropsy revealed no remarkable findings.
Based on the results observed, the dermal LD50 of Santicizer P1400 was determined to be greater than 2000 mg/Kg of body weight in rabbits. According to GHS Classification, Santicizer P1400 meets the criteria to be classified as Acute Toxic Category 5.
Reference
Table 1. Body Weights and Dose Volume |
|||||
Animal No. |
Sex |
Dose Volume (mL) |
Body Weight (Kg) |
||
Day 0 |
Day 7 |
Day 14 |
|||
H3813 |
Male |
5.5 |
2.9 |
3.0 |
3.1 |
H3842 |
Male |
4.6 |
2.4 |
2.6 |
2.6 |
H3816 |
Male |
5.3 |
2.8 |
2.9 |
3.0 |
H3802 |
Male |
5.3 |
2.8 |
3.0 |
3.0 |
H3803 |
Male |
5.3 |
2.8 |
2.9 |
3.0 |
Mean |
2.7 |
2.9 |
2.9 |
||
S.D. |
0.2 |
0.2 |
0.2 |
||
# |
5 |
5 |
5 |
||
|
|||||
H3829 |
Female |
5.7 |
3.0 |
3.2 |
3.1 |
H3830 |
Female |
5.3 |
2.8 |
3.0 |
3.2 |
H3831 |
Female |
5.3 |
2.8 |
3.0 |
3.0 |
H3824 |
Female |
5.5 |
2.9 |
2.9 |
3.1 |
H3825 |
Female |
5.3 |
2.8 |
3.0 |
3.2 |
Mean |
2.9 |
3.0 |
3.1 |
||
S.D. |
0.1 |
0. |
0.1 |
||
# |
5 |
5 |
5 |
Table 2. Dermal Observations |
|||||||||||
Time Periods |
Animal Number and Sex |
||||||||||
Male |
Female |
||||||||||
H3813 |
H3842 |
H3816 |
H3802 |
H3803 |
H3829 |
H3830 |
H3831 |
H3824 |
H3825 |
||
24-hour |
Erythema |
2 |
2 |
1 |
1 |
2 |
2 |
1 |
2 |
1 |
2 |
Edema |
2 |
1 |
2 |
2 |
1 |
0 |
1 |
2 |
2 |
1 |
|
Day 14 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table3. Necropsy Observations |
||||||||||
Animal Number |
H3813 |
H3842 |
H3816 |
H3802 |
H3803 |
H3829 |
H3830 |
H3831 |
H3824 |
H3825 |
Sex |
Male |
Female |
||||||||
Death (D) / Sacrifice (S) |
S |
S |
S |
S |
S |
S |
S |
S |
S |
S |
Observation |
|
|||||||||
Normal |
X |
X |
X |
X |
X |
|
X |
X |
X |
X |
Anogenital area: soiled |
|
|
|
|
|
X |
|
|
|
|
X: Observed
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Adequate for assessment
Additional information
Justification for classification or non-classification
P1400 is not classified as hazardous according to the CLP regulation.
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