Registration Dossier

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:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TEST SUBSTANCE
The test substance consists of a chemical compound.
Product OXALIC ACID DI-HYDRATE
Components Oxalic Acid
Stability 6 months
Formula (COOH)2 2H2O
CAS N° 6153-56-6
TESTED SAMPLE
The test substance consisted of a fine white crystal.
Batch MAR 10-10
Manufacturing date March 2010
Expiry date September 2010
Water solubility 10g/100 ml (water at 20°C)
CoA See Addendum N,1
Receiving EUITVI-7606
Date March 9th, 2010
#ID 10.322-S

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Duration of treatment / exposure:
Skin preparation:
4 hours before the beginning of the test an area of approximately 240 cm2 has been shaved off from the
back and hips of the animals. An area of about 6 cm2 was used for the application of the assay sample.

Application:
500 mg of the test substance have been applied on the animal’s skin, after humidification with
physiological solution, with a square gauze (2.5 cm x 2.5 cm) and fixed with an elastic bandaging.

Removal of the patches:
The patches have been removed 4 hours after the application.
The exceeding substance has then been cleansed off from skin using a pad soaked with physiological
solution.
Observation period:
OBSERVATIONS
The general conditions of the animals have been daily verified. Skin reactions have been evaluated one
hour after removal of the patches.
The evaluation has been repeated 24, 48 and 72 hours after the application.
Number of animals:
Three rabbits have been used to perform the test.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 minutes
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 min
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Other effects:
not other effect

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the results, interpreted according to Official Journal of the European Union
2001/59/EC dated August 6th, 2001 and OECD n° 404 April 24th 2002, the test substance “OXALIC
ACID DI-HYDRATE” must be considered NOT IRRITANT for the skin.
Executive summary:

A GLP Laboratory test has been conducted following the OECD Guideline TG 404 for Skin irritation.

On the basis of the results, interpreted according to Regulation CE 1272/2008, the test substance “OXALIC ACID DI-HYDRATE” must be considered NOT IRRITANT for the skin.