Registration Dossier

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:
other: Guideline study under GLP, no deviations; dose level sufficeient for classification and risk assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
500 mg SMC / 0.19 ml physiol. saline
Duration of treatment / exposure:
4 hour
Observation period:
72 hrs
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: all scores for all animals:
Max. score:
0
Reversibility:
other: not applicable with zero score
Irritation parameter:
edema score
Basis:
other: all scores of all animals
Max. score:
0
Reversibility:
other: not applicable with zero score
Irritant / corrosive response data:
no edema, o erythema, no corrosion
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.