Registration Dossier

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
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2- 2.9 kg
No further data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Observation period (in vivo):
14 days (observations at 24, 48 and 72 hours and at 4, 7, 10 and 14 days)
Number of animals or in vitro replicates:
Nine
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Three eyes washed after two seconds, three after four seconds and three eyes not washed.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: 2% fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Unwashed. Corneal bulging with whitish coloured fluid discharge at 14 days.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 2 on Days 7 and 10.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: No scores as blanched.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Unwashed. Grade 4 on Day 14
Irritation parameter:
iris score
Basis:
animal #2
Remarks on result:
other: Because of severe opacity over the rest of the cornea, the iris could not be observed or graded.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks on result:
other: No score as blanched.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Remarks on result:
other: Unwashed. Due to severe bulging of the cornea, opacity could not be graded on Days 7 and 10.
Irritation parameter:
iris score
Basis:
animal #3
Remarks on result:
other: Because of severe opacity covering the rest of the cornea, the iris could not be observed or graded.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks on result:
other: No scores as blanched.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14.
Irritant / corrosive response data:
Signs of irritation were observed in all eyes from 24 hours through to termination of the study and consisted of moderate to severe opacity, slight to moderate iritis (two eyes could not be observed for iritis throughout the study due to severe opacity), blanching of the conjunctivae, slight to severe chemosis, and slight to moderate discharge. Other signs of irritation included sloughing of the corneal epithelium in seven eyes, sloughing of blanched areas of conjunctivae in three eyes, sluggish pupillary response in eight eyes, alopecia around eye in one eye, bulging of cornea and discharge from cornea in four eyes, and vascularisation of the corneal epithelium in three eyes. The cornea could not be stained with fluorescein at 14 days due to bulging and discharge in four eyes. Positive fluorescein staining on Day 14 revealed corneal damage in five eyes. Only scores for unwashed eyes are presented.
Other effects:
Blinking in all animals, phonation in six animals, and preening in five animals were observed immediately after instillation of the test substance.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In an eye irritation/corrosion study conducted using a protocol similar to OECD TG 405, but not compliant with GLP (reliability score 2) methylsilanetriyl triacetate caused severe, irreversible damage to the eyes of rabbits.