Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
sodium monochloroacetate
IUPAC Name:
sodium monochloroacetate
Details on test material:
96.2 % pure. impurities MCAA 1,45%, sodium carbonate 1,48%, iron 2,7% others each < 1%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3 animals, weight 2.5-2.9 kgs, age 3-5 months
fully climatized room, single cages
temp. 20+-3 degr C
rel. humidity 50+-20
light /dark 12/12
feed Altrom 2123 rabbit feed
water de-ionized chlorinated water ad lib.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
prior to dosing, eyes were examined with fluorescein under UV to exclude existing damage
dosing: 100 mg in left eye; fflushed out after 24 hrs with physiologial saline.
evaluation 1 ,24, 48, 72 hrs and 7 days after dosing
effects on cornea, iris, coniunctivae numerically rated, all other effects recorded in writing

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.44
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Time post application 1 hr 24 hrs 48 hrs 72 hrs 7 days
Animal nr 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
chemosis 3 3 3 3 2 2 2 2 2 1 1 0 0 0 0
Coniunctival erythema 3 3 3 3 3 3 3 2 2 2 2 2 0 0 0
Iris 1 1 1 1 1 1 1 0 1 0 0 1 0 0 0
Corneal clouding 0 0 0 2 0 0 2 1 1 1 1 1 0 0 0
Corneal epithelial defects         1 1       1 1 1 0 0 0
Clear discharge x x x                        
White thick discharge       x x x x                
Corneal bleeding         x   x     x          
Red iris x x x x x x x   x     x      

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
moderately irritating, also cat. 2 based on CLP criteria

Categories Display