Registration Dossier

Toxicological information

Eye irritation

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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:
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
Name:
Unnamed
Type:
Constituent
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