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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 930-930-0 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/03/2018 - 23/04/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Calcium peroxide
- EC Number:
- 215-139-4
- EC Name:
- Calcium peroxide
- Cas Number:
- 1305-79-9
- Molecular formula:
- CaO2
- IUPAC Name:
- calcium peroxide
- Reference substance name:
- Calcium dihydroxide
- EC Number:
- 215-137-3
- EC Name:
- Calcium dihydroxide
- Cas Number:
- 1305-62-0
- Molecular formula:
- CaH2O2
- IUPAC Name:
- calcium dihydroxide
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10-11 weeks old.
- Weight at study initiation: 192 to 212 g.
- Housing: On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) ad libitum.
- Water: tap-water from public distribution system ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 43 - 51
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- other: non-occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: at least 10% of the body surface area
- % coverage: at least 10% of the body surface area
- Type of wrap if used: non-occlusive porous gauze dressing (50x50 mm2 non-woven swab, 4-layer patch, MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic micropore™ adhesive tape from 3M).
REMOVAL OF TEST SUBSTANCE
- Washing: the gauze dressings were removed and the treated area was rinsed with distilled water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 0.2 g/ml
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL
- Concentration (if solution): 1% aqueous CMC
- Lot/batch no. (if required): Genfarma, Zaandam (NL)
- Rationale: selected based on the results of trial preparation of formulations. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- yes
- Remarks:
- control group referred to historical values.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, the animals were weighed on day 0 (just before administering the test item) then on day 2, day 7, and day 14.
- Necropsy of survivors performed: yes. Observed organs: oesophagus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, testicles, adrenals, pancreas. As no abnormalities were observed, no microscopic examinations were performed.
- Other examinations performed: clinical signs, body weight. Histopathological examination was not performed because no macroscopic anomalies were observed in any organ.
Results and discussion
- Preliminary study:
- One animal was dosed at 1000 mg/kg in order to select the dose causing no mortality or significant toxicity to be used in the main study. Based on the results, one additional animal was dosed at 1000 mg/kg 48h after the first. Based on the results of the range finding study, two animals were dosed at 2000 mg/kg.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: At 2000 mg/kg, fissures, scales, scabs, general erythema and/or white staining were seen in the treated skin-area of the animals between Days 2 and 15. Scabs and/or focal erythema were noted on the back of two animals between Days 8 and 15. Chromodacryor
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
Table 1 MORTALITY DATA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FEMALES 1000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Table 2 CLINICAL SIGNS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||
ANIMAL 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin / fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
White staining (Treated skin) |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion / excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (Snout) |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
||||||||||||||||||
ANIMAL 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin / fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema focal (Back) |
(4) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
Fissures (Treated skin) |
(3) |
- |
- |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Scabs (Back) |
(3) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
- |
White staining (Treated skin) |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Red (Treated skin) |
(1) |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
||||||||||||||||||
ANIMAL 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin / fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Scabs (Back) |
(3) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
White staining (Treated skin) |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion / excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (Nose) |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin / fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
Scabs (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
White staining (Treated skin) |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion / excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (Nose) |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- = Sign not observed |
Table 3 BODY WEIGHTS (GRAM) |
|
||||
|
|
|
|
|
|
|
|||||
|
1 |
200 |
199 |
218 |
|
|
|
|
|
|
|
|
MEAN |
200 |
199 |
218 |
|
|
ST.DEV. |
--- |
--- |
--- |
|
|
N |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
|||||
|
2 |
192 |
192 |
211 |
|
|
|
|
|
|
|
|
MEAN |
192 |
192 |
211 |
|
|
ST.DEV. |
--- |
--- |
--- |
|
|
N |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
|||||
|
3 |
207 |
180 |
224 |
|
|
4 |
212 |
185 |
218 |
|
|
|
|
|
|
|
|
MEAN |
210 |
183 |
221 |
|
|
ST.DEV. |
4 |
4 |
4 |
|
|
N |
2 |
2 |
2 |
|
|
|
|
|
|
|
Table 4 MACROSCOPIC FINDINGS |
|||
|
|
|
|
|
|||
1 |
|
No findings noted |
Scheduled necropsy |
|
|
|
Day 15 after treatment |
|
|||
2 |
|
No findings noted |
Scheduled necropsy |
|
|
|
Day 15 after treatment |
|
|||
3 |
|
No findings noted |
Scheduled necropsy |
|
|
|
Day 15 after treatment |
4 |
|
No findings noted |
Scheduled necropsy |
|
|
|
Day 15 after treatment |
Table 5 IRRITATION |
|||||||
|
|
|
|
|
|||
|
|
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
|||||||
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|||||||
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|||||||
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria.
- Conclusions:
- The dermal LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
To determine the acute dermal toxicity of the test item in rats, a limit test was performed, according to OECD 402 (GLP study). Initially, the test item was administered to single female Wistar rats by a single dermal application at 1000 mg/kg and 2000 mg/kg body weight for 24 hours in a range finding study. Based on the results, the main study was performed by dosing two females at 2000 mg/kg. All animals were subjected to daily observations and weekly determination of body weight for 14 days. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). No mortality ocurred at any dose tested. No significant signs of systemic toxicity were noted at 1000 mg/kg. At 2000 mg/kg, fissures, scales, scabs, general erythema and/or white staining were seen in the treated skin-area of the animals between Days 2 and 15. Scabs and/or focal erythema were noted on the back of two animals between Days 8 and 15. Chromodacryorrhoea of the nose was noted for two animals on Day 1. Based on the study results, the dermal LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg body weight.
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.