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Toxicological information

Skin irritation / corrosion

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Administrative data

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

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.4 (Acute Toxicity: Dermal 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

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.

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables


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

Applicant's summary and conclusion

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.