Reaction mass of calcium disilicide and calcium silicide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

22 Oct. - 05 Nov 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Read-across to synthetic amorphous silica.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Silicon dioxide

EC Number:

231-545-4

EC Name:

Silicon dioxide

Cas Number:

7631-86-9

Molecular formula:

O2Si

IUPAC Name:

Silicon dioxide

Details on test material:

Sident 9, CAS-Name: Silica, precipitated, cryst.-free; CAS-No.: 112926-00-8
SiO2 >98% , Na20 <1%, Al2O3 <0.2%, SO3 <0.8%, Fe2O3 <0.03%:

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

dose: 100 mg

Duration of treatment / exposure:

24 h, not rinsed

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

Comment: not rinsed
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
- Time after start of exposure: 24 h


SCORING SYSTEM: Intensities of irritation effects by using the Draize scale for grading of lesions (scores 0 - 4).
Irritation index: calculated according to Draize from grades on cornea, iris and conjunctiva at the time 1, 24, 48 and 72 h,
modified according to Gilman et al. 1983

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Reversibility:

fully reversible

Remarks on result:

other: weakly irritating. There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, score 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge was very slight only 1 h after application (score 1)

Irritant / corrosive response data:

There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, score 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge was very slight only 1 h after application (score 1).

Any other information on results incl. tables

There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, score 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge was very slight only 1 h after application (score 1).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No classification (EU and GHS)

Executive summary:

Jahn and Berthold (1991) studied eye irritation of precipitated silica. There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, score 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge was very slight only 1 h after application (score 1).