Silicic acid, titanium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: National guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.11 (formely 21 CFR 191.11)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, titanium salt

EC Number:

255-911-8

EC Name:

Silicic acid, titanium salt

Cas Number:

42613-21-8

Molecular formula:

TiSixOy, where x and y are unspecified.

IUPAC Name:

titanium(4+) bis(oxosilanebis(olate))

Details on test material:

- Name of test material (as cited in study report): Magnapore 963 FP
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Rabbit Farm
- sex: females
- Weight at study initiation: 1.55-1.75 kg on receipt
- Diet: Big Red Rabbit Chow (Pro-pet Inc., Wilmington DE), ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

- Aqueous slurry of 1 g Magnapore and 1 ml water;
- 0.5 mL of the slurry were applied to the rabbits on two layers of surgical gauze

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 25X25 mm
- The animals were prepared by clipping their sides closely with an appropriate electric clipper 24 hours before the beginning of the experiment. Two experimental areas were prepared on each animal: one site was left intact, the other side was superficially abraded by shallow incisions through the stratum corneum without causing bleeding. Since the results of the abraded skin are not relevant for the hazard assessment, they are not shown.
- 0.5 mL of the test material were applied to the rabbits on two layers of surgical gauze which were placed on the experimental skin site and tightly occluded by means of a large piece of dental rubber dam over paraffin film. All bandaged were secured by mean of adhesive tape.
- Observations for systemic toxicity were recorded after 12, 24 and 72 hours, signs of dermal irritation at 24 and 72 hours.

REMOVAL OF TEST SUBSTANCE
- No

SCORING SYSTEM:
- According to: Draize Dermal Irritating Scoring System (Draize, 1959)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

0

Max. score:

0

Remarks on result:

other: Edema, erythema and eschar formation

Any other information on results incl. tables

There were no systemic toxic effects observed in any of the animals.

The material is virtually non-irritating.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information