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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-858-4 | CAS number: 12037-47-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Silicon orthophosphate
- EC Number:
- 234-858-4
- EC Name:
- Silicon orthophosphate
- Cas Number:
- 12037-47-7
- Molecular formula:
- O16P4Si3
- IUPAC Name:
- silicon(4+) tetraphosphate
- Details on test material:
- - Name of test material (as cited in study report): silicon orthophosphate
- Physical state: solid, light grey
- Analytical purity: >80% (w/w)
- Batch No.: 5
- Storage condition of test material: at room temperature, dry atmosphere, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8-10 wks (males), 12-14 wks (females)
- Weight at study initiation: 235-247 g (males), 215-238 wks (females)
- Housing: individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot 261111)
- Diet (ad libitum): Altromin 1324 (lot 0715)
- Water (ad libitum): tap water, sulphur acidified to a pH of approximately 2.8
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: 10% of the total body surface
- Type of wrap if used: The test item was held in contact with the skin by a dressing throughout a 24-h period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: at the end of the 24 h exposure period the residual test item was removed using aqua ad injectionem
- For solids, paste formed: yes, the test substance was moistened with aqua ad injectionem - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: cageside observations were done several times on the days of dosing and once a day until the end of the observation period. Observations included general symptoms, changes in the skin and fur, eyes, and mucous membranes. Also changes in respiratory, circulatory, autonomic and centrals nervous system and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors convulsions, salivation, diarrhea, lethargy, sleep and coma. Weighing was done on day 1 (prior to application) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: primary skin irritation was assessed using the scoring system of Draize
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which was due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
- Other findings:
- - Other observations: Erythema grade 1 was observed in 1 of 5 female animals on Days 2 and 3 after start of the application. Scratches and eschar were observed in all male and female animals. All signs of irritation were reversible within the observation period. Edema was not observed (see Tables 2 and 3).
Any other information on results incl. tables
Table 1: Body weight development (in g and %)
Sex |
Day 1 (g) |
Day 8 (g) |
Day 15 (g) |
Day 1-15 (%) |
male |
238 |
260 |
300 |
26 |
male |
243 |
257 |
287 |
18 |
male |
247 |
266 |
303 |
23 |
male |
238 |
256 |
280 |
18 |
male |
235 |
244 |
279 |
19 |
female |
238 |
239 |
255 |
7 |
female |
215 |
220 |
227 |
6 |
female |
220 |
216 |
229 |
4 |
female |
217 |
215 |
235 |
8 |
female |
226 |
223 |
230 |
2 |
Table 2: Skin irritation: Individual data - Males
Day after start application |
Animal No. 21 |
Animal No. 22 |
Animal No. 23 |
Animal No. 24 |
Animal No. 25 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
Day 2 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 3 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s* |
Day 4 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
Day 5 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
(es, s)* |
0/0 |
es, s |
Day 6 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
(es, s)* |
0/0 |
es, s |
Day 7 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
Day 8 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
nsf |
0/0 |
nsf |
Day 9 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
nsf |
0/0 |
nsf |
Day 10 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 11 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 12 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 13 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 14 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Comments:
E = erythema, O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2, Draize scoring system)
es = eschar, s = scratches, s* = small scratches, (es, s)* = eschar and scratches on the edge of the application site; nsf = no specific finding
Table 3: Skin irritation: Individual data - Females
Day after start application |
Animal No. 26 |
Animal No. 27 |
Animal No. 28 |
Animal No. 29 |
Animal No. 30 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
Day 2 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 3 |
1/0 |
es, s* |
0/0 |
es, s |
0/0 |
es, s* |
0/0 |
es, s* |
0/0 |
s* |
Day 4 |
1/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
nsf |
Day 5 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
(es, s)* |
0/0 |
nsf |
Day 6 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
(es, s)* |
0/0 |
nsf |
Day 7 |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
nsf |
Day 8 |
0/0 |
nsf |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
nsf |
0/0 |
nsf |
Day 9 |
0/0 |
nsf |
0/0 |
es, s |
0/0 |
es, s |
0/0 |
nsf |
0/0 |
nsf |
Day 10 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 11 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 12 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 13 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 14 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Comments:
E = erythema, O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2, Draize scoring system)
es = eschar, s = scratches, s* = small scratches, (es, s)* = eschar and scratches on the edge of the application site; nsf = no specific finding
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
