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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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).