Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion: not irritant

Eye irritation: moderately irritant

Respiratory irriation: no data

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 animals, weight 2.5-2.9 kg, 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.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
500 mg SMC / 0.18 mL physiol. saline
Duration of treatment / exposure:
4 hour
Observation period:
30-60 min, 24, 48 and 72 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable with score zero
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable with score zero
Remarks on result:
no indication of irritation
Other effects:
none


30'

24 hrs

48 hrs

72 hrs

Animal nr

1

2

3

1

2

3

1

2

3

1

2

3

erythema

0

0

0

0

0

0

0

0

0

0

0

0

edema

0

0

0

0

0

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
SMCA is not a skin irritant
Executive summary:

The sodium salt of monochloroacetiac acid (SMCA) was tested for skin irriation / corrosion in acordance with EU protocol B.4 under GLP. The substance was found not to be irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

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

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

key study (EU protocol B.4, GLP) indicates that SMCA is not a skin irritant

key study (EU protocol B.5, GLP) indicates that SMCA is a moderate eye irritant

no data on respiratory irritation


Justification for classification or non-classification

Based on the available animal data and experience in humans SMCA need to be classified for irritation to eyes (GHS/CLP cat. 2).

Although SMCA did not show skin irritation, CLP ANNEX VI classification indicates classification as a skin irritant cat. 2 (H315).