Registration Dossier
Registration Dossier
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EC number: 701-085-3 | CAS number: -
Eye irritation
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substance Act: CFR part 191, Chapter I, Title 21, Fed. Register 26, p. 7333, 12 Aug. 1961 / Fed. Regulation, 29, No. 182, p. 13009, 17 Sep. 1964
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicic acid, calcium salt
- EC Number:
- 215-710-8
- EC Name:
- Silicic acid, calcium salt
- Cas Number:
- 1344-95-2
- IUPAC Name:
- Silicic acid, Calcium salt
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BR-19
- Composition of test material, percentage of components: SiO2 (62%); Al2O3 (11.6%); Na2O (8.3%) (see Jones 1975)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- unlimited contact, no rinse
- Observation period (in vivo):
- 1, 24, 48, 72 h, 7 and 14 d after application
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scoring system for descriptive rating of ocular lesions (cornea, iris, and conjunctiva);
numerical transformation into weighted scores for grading of severity of ocular lesions with score maximum of 110 points:
80 (cornea) + 10 (iris) + 20 (conjunctiva).
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 37.7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 - 14 d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 35
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 - 14 d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 17.4
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 - 14 d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 5.9
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 - 14 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 - 14 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 - 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 - 7 d
- Remarks on result:
- other: Score maximum each for erythema and secretion, based on the scale given.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 d
- Remarks on result:
- other: Score maximum for edema
- Irritant / corrosive response data:
- Haemorrhagic conjunctivae were observed after the first hour post-application, which subsided after 24 h.
Individual scores after 24 - 72 h: Cornea 0 - 1, iris 0 - 1, conjunctivae 1 - 2 for erythema, edema and discharge but 2/6 with score 3 for secretion.
Effects were fully reversible within 7 d except for slight residual lesions of the cornea in 3/6 animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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