Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-710-8 | CAS number: 1344-95-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study based on national guideline, limited documentation, 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, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Details on test material:
- - Name of test material (as cited in study report): BR-19
- Substance type: inorganic
- Physical state: solid, white powder
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: SiO2 (62%); Al2O3 (11.6%); Na2O (8.3%) (see Jones 1975)
Constituent 1
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:
- other: 24 h
- Score:
- 35
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 - 14 d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 17.4
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 - 14 d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 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:
- other: 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:
- other: 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:
- other: 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:
- other: 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:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on current standards, the irritation effects and development over time observed do not justify classification:
Criteria for classification: 24 - 72h mean cornea score >=2; iris score >=1; conjunctivae (erythema) >=2.5; conjunctivae (edema) >=2
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
