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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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).