Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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