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Toxicological information

Skin irritation / corrosion

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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:
1994
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

Constituent 1
Chemical structure
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

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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