Silicic acid, aluminum calcium sodium salt

Endpoint summary

Description of key information

The registered substance is not classified as a skin irritant or an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted by GLP compliant laboratory using OECD Testing Guideline 404.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: Japanese white

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes

Amount / concentration applied:

0.4 ml

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

6

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

0.17

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 h

Score:

0.03

4 hours after application of the test material, erythema grade one was observed. This had disappeared 24 hours after application.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was not found to be a skin irritant with a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 recorded 48 hours after application of the substance. The substance is therefore not considered a skin irritant.

Executive summary:

The skin irritation potential of the substance was determined in accordance with the OECD Guideline for Testing of Chemiclas 404. The substance was applied in semi-occlusive coverage to the clipped skin of rabbits. After 48 hours a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 was recorded. The substance is not classified as a skin irritant according to EU CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study meets generally accepted scientific standards, is sufficiently documented, and is considered acceptable for assessment. The study was conducted according to Federal Hazardous Substances Act Section 191.12 (1973). Read-across from the results on the test substance has been made to the registered substance based on the similar structure of the two substances.

Qualifier:

according to guideline

Guideline:

other: Fed. Hazardous Substance Act Section 191.12 (1973)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):

24, 48, and 72 hours following application.

Number of animals or in vitro replicates:

6

Details on study design:

Comment: not rinsed

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24 h

Score:

3.3

Max. score:

20

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Based on the effects of redness (A), swelling (B) and discharge (C) with (A+B+C)x2/number of animals = 3.3

Irritant / corrosive response data:

Only on day 1, transient slight erythema and edema were noted in all animals (effect score 1), in one animal score 2 for erythema; cornea and iris remained unaffected. No irritating effects any more after 48 h.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria.

Executive summary:

The eye irritation potential of the test substance was determined in accordance with the test guideline outlined in the Federal Hazardous Substances Act Section 191.12 (1973). 100 mg of the test substance was applied to rabbit eyes and observations made 24, 48 and 72 hours after application. The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria. The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

A study was conducted on the registered substance to determine the skin irritation potential of the substance. The skin irritation potential of the substance was determined in accordance with the OECD Guideline for Testing of Chemiclas 404. The substance was applied in semi-occlusive coverage to the clipped skin of rabbits. After 48 hours a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 was recorded. The substance is not classified as a skin irritant according to EU CLP criteria.

A study was conducted on a structurally similar substance to determine the eye irritation potential of the substance. The eye irritation potential of the test substance was determined in accordance with the test guideline outlined in the Federal Hazardous Substances Act Section 191.12 (1973). 100 mg of the test substance was applied to rabbit eyes and observations made 24, 48 and 72 hours after application. The conjunctivae score (mean of 6 animals) was found to be 3.3, with effects fully reversible within 48 hours. The substance is therefore not classified as an eye irritant according to EU CLP criteria.

The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.

Justification for selection of skin irritation / corrosion endpoint:
Study was conducted on the registered substance according to GLP standards and using OECD Testing Guideline 404.

Justification for selection of eye irritation endpoint:
Study was conducted on the substance silicic acid, aluminium, sodium salt, which is structurally similar to the registered substance, thereby justifying read-across of results. The study was conducted using the testing guideline included in the Federal Hazardous Substance Act Section 191.12 (1973).

Justification for classification or non-classification

No irrititation potential was found in either the skin or eye irritation studies.