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:
1975-05-16 to 1975-06-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US FHSLA
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Chemical name: C12-C16-alkyldimethylbenzylammoniumchlorid
CAS: 68424-85-1
Mean MW: 357 g/mol
Specific details on test material used for the study:
- Name in the test report: Barquat MB-80

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits
Details on test animals or tissues and environmental conditions:
n.a.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
once; eyes were not rinsed after administration
Observation period (in vivo):
24, 48 and 72 h
Duration of post- treatment incubation (in vitro):
n.a.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed after administration of the test substance.

SCORING SYSTEM: Scoring according to the method of Draize:


Cornea:
Opacity: degree of density (area most dense taken for reading)
0 - No ulceration or opacity
1 - Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 - Easily discernible translucent areas, details of iris slightly obscured
3 - Nacreous areas, no details of iris visible, size of pupil barely discernible
4 - Opaque cornea, iris not discernible through the opacity

Area of cornea involved
1 - One quarter (or less) but not zero
2 - Greater than one quarter, but less than half
3 - Greater than half, but less than three quarter
4 - Greater than three quarters, up to whole area

Iris
0 - Normal
1 - Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 - No reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
0 - Blood vessels normal
1 - Some blood vessels definitely hyperaemic (injected)
2 - Diffuse, crimson colour, individual vessels not easily discernible
3 - Diffuse, beefy red

Chemosis (lids and/or nictating membranes)
0 - No swelling
1 - Any swelling above normal (includes nictitating membranes)
2 - Obvious swelling with partial eversion of lids
3 - Swelling with lids about half-closed
4 - Swelling with lids more than half-closed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Other effects:
n.a.

Any other information on results incl. tables

Table 2: Individual Eye Irritation Scores

Animal No. Observation time point Cornea opacity Iris Conjunctivae redness Conjunctivae chemosis
1 24 h 4 2 3 4
48 h 4 2 3 4
72 h 4 2 3 4
2 24 h 4 2 3 4
48 h 4 2 3 4
72 h 4 2 3 4
3 24 h 4 2 3 4
48 h 4 2 3 4
72 h 4 2 3 4
4 24 h 4 2 3 4
48 h 4 2 3 4
72 h 4 2 3 4
5 24 h 4 2 3 4
48 h 4 2 3 4
72 h 4 2 3 4
6 24 h 4 2 3 4
48 h 4 2 3 4
72 h 4 2 3 4

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under experimental conditions, the test substance, Barquat MB-80, was seen as severe corrosive to the eyes of rabbits.
Executive summary:

In a primary eye irritation study conducted according to US FHSLA, 0.1 mL of the test item, Barquat MB-80 was instilled into the conjunctival sac of six albino rabbits. All treated eyes were unwashed. Animals were observed for 72 hours with examination at 24, 48 and 72 h after test substance administration. Eye lesions were scored by the method of Draize. Severe corrosive effects were observed so that the maximum score of all lesions has been reached in each animal. In this study, the test substance was seen to be severe corrosive and classification for Eye Dam. 1 based on CLP criteria is warranted.