Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize-Test; Hazardous Substances, Part 191, Section 12, Federal Register, Vol. 37, No. 83, FDA, Washington 1972
Principles of method if other than guideline:
1 dose level, single administration, rinsing after 5 min. or 24 h., 7-day post observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform, no surface treatment
Details on test material:
precipitated, Cas.-No.: 112926-00-8, Surface Area/BET [m2/g]: 170-210
Specific details on test material used for the study:
amorphous silicon dioxide Sipernat 22

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: V2A steel cages
- Diet: Altromin 2023, ad libitum except treatment day
- Water: tap water, ad libitum except treatment day
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-2 °C
- Humidity (%): 60 +- 3
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
group I: 5 minutes (rinsed thereafter)
group II: 24 hours (rinsed thereafter)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
group I: 5 animals
group II: 3 animals
Details on study design:
The substance was applied into the conjunctival sac of the left eye, while the right eye remained untreated serving as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24 ,48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
eyes rinsed after 5 min. or 24 h.
Time point:
other: 1, 24, 48, 72 h, 7 d
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritating response at any time after exposure (1 h - 7 d).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Sipernat 22 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide Sipernat 22 was assessed in rabbits.