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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Oct. - 05 Nov 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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

Constituent 1
Chemical structure
Reference substance name:
Silicon dioxide
EC Number:
231-545-4
EC Name:
Silicon dioxide
Cas Number:
7631-86-9
Molecular formula:
O2Si
IUPAC Name:
dioxosilane
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

Resultsopen allclose all
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #1
Remarks:
ID Nr. 2303
Time point:
other: 1 h after application
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #2
Remarks:
ID Nr. 2331
Time point:
other: 1 h after application
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #3
Remarks:
ID Nr. 2374
Time point:
other: 1 h after application
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #1
Remarks:
ID Nr. 2303
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #2
Remarks:
ID Nr. 2313
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #3
Remarks:
ID Nr. 2374
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #2
Remarks:
ID 2313
Time point:
other: 4 days
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #2
Remarks:
ID Nr. 2313
Time point:
7 d
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The conjuctiva reacted with diffuse redness (grade 2) in all 3 animals 1h after application. The findings had completely disappeared after 72 h to 7 days. Only at the day of application the conjuctivas were swollen (Grade 1). In addition, a slight discharge (grade 1) was observed in all 3 animals at the day of application. All effects were reversible after 48h, 72h or 7 days respectively.
It is considered that all effects were induced by the physical property (dust) of the test substance. Therefore the test substance was considered to be not irritant.

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:
GHS criteria not met
Conclusions:
No classification (EU and GHS)
Executive summary:

Jahn and Berthold (1991) studied eye irritation of precipitated silica in rabbits by the OECD 405 guideline test method. 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 were very slight only 1 h after application (score 1).