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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1975
Report date:
1975
Reference Type:
other company data
Title:
Unnamed
Year:
1975
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

Constituent 1
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)

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