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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Fed. Hazardous Substance Act Section 191.12 (1973)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, aluminum sodium salt
EC Number:
215-684-8
EC Name:
Silicic acid, aluminum sodium salt
Cas Number:
1344-00-9
Molecular formula:
nSiO2*mAl2O3*zNa2O n = 2-4; m = 0,07 - 0,53; z = 0,11-0,50 Provided stoichiometric data are in accordance with commission regulation (EU) No 231/2012 (Specification E 554)
IUPAC Name:
Silicic acid, aluminum sodium salt
Details on test material:
ZEOLEX 23A - surface area (BET): 65 -80 m2/g, pH 9.8 - 10.6

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg


Observation period (in vivo):
24, 48, and 72 following application
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24 h
Score:
3.3
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Based on the effects of redness (A), swelling (B) and discharge (C) with (A+B+C)x2/number of animals = 3.3
Irritant / corrosive response data:
Only on day 1, transient slight erythema and edema were noted in all animals (effect score 1), in one animal score 2 for erythema; cornea and iris remained unaffected. No irritating effects any more after 48 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information