Registration Dossier
Registration Dossier
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EC number: 237-623-4 | CAS number: 13870-28-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-05-19 until 1987-05-22
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- , adopted: 12 May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- , directive 84/449/EWG
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium disilicate
- EC Number:
- 237-623-4
- EC Name:
- Disodium disilicate
- Cas Number:
- 13870-28-5
- Molecular formula:
- Na2Si2O5
- IUPAC Name:
- disodium disilicate
- Details on test material:
- - Name of test material (as cited in study report): Natriumschichtsilikat Na-SKS-6 kristallin
- Physical state and appearance: White powder
- Analytical purity: > 99%
- Storage condition of test material: Darkness at room temperature in a fume cupboard
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: About 3-5 months
- Weight at study initiation: 2.4- 3.5 kg
- Housing: In fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet- rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): Water from automatic water dispensers, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50- 20%
- Photoperiod (hrs dark / hrs light): Lighting time: 12 hours daily
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g of the test substance
The amount applied (0.5 g) was pasted with 0.2 mL isotonic saline. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes and 24, 48, 72 hours after removal of the patches.
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The substance was applied over the whole surface of a cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
SCORING SYSTEM: The scoring system is as instructed by the relevant guidelines according to the technique of Draize.
REMOVAL OF TEST SUBSTANCE
- After the exposure period (4 hours) all remnants of the test substance were carefully removed from the skin with warm tap water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score (0) is a mean value of the results obtained at the time points indicated above for animal # 1.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score (0) is a mean value of the results obtained at the time points indicated above for animal # 2.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score (0) is a mean value of the results obtained at the time points indicated above for animal # 3.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score (0) is a mean value of the results obtained at the time points indicated above for animal # 1.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score (0) is a mean value of the results obtained at the time points indicated above for animal # 2.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score (0) is a mean value of the results obtained at the time points indicated above for animal # 3.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of irritation were observed during the whole observation period.
- Other effects:
- No other effects
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study disodium disilicate (delta-crystalline) is not irritating to the skin.
- Executive summary:
In a primary dermal irritation study (study no.: 94.0712), 3 male and female New Zealand albino rabbits (weight: 2.4 - 3.5 kg, age: 3 - 5 months) were dermally exposed to disodium disilicate (delta-crystalline). 0.5 g of the test substance was pasted with 0.2 mL isotonic saline on a 2.5 cm x 2.5 cm cellulose patch which was fixed in a semi-occlusive dressing for 4 hours. Animals were observed for up to 72 hours after removal of the patches. The study was conducted according to the OECD 404 guideline and the EG guideline B.4 and irritation was scored by the method of DRAIZE.
No cutaneous reactions (edema, erythema or corrssion) were recorded in any of the observation time points (each determined score was 0.0). Thus, under the study conditions the test substance, disodium disilicate (delta-crystalline), in rabbits exhibit no potential as a skin irritant.
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