Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP; Study according to OECD-Guideline of Mai 1981 lack of data on the purity / quality of the sample tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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:
Citrowanil B

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Five adult White New Zealands with the average weight of 2.5 kg have been used for the procedure.
The animals were housed in single cages and were fed with a standard laboratory diet for rabbits (Altromin/Lage) and were watered ad libitum.
The room temperature was kept constantly at 18 °C +/- 2 °C, the relative humidity 50 - 60 % and daily illumination time was 12 hours.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml test substance were administered to skin by means of a 2.5 cm² cellulose patch.
Duration of treatment / exposure:
24 hours
Observation period:
24 hours, 72 hours and 7 days
Number of animals:
5
Details on study design:
Primary skin irritation was tested by the patch method on shaved and scarified skin of albino rabbits.
The animals were fixed in an immobilisation cage and the patch by means of leucoplast. All the trunk of the animal was enwrapped into a rubber cloth for 24 hours in order to delay evaporation of etheric substances.
After 24 hours the bandage was removed and local reaction was classifid by points. Readings were repeated 72 hours post application and the final score was the average of 24 and 72 hours reading. After 7 days localizations were controlled finally.
For reproduction 2 treated localizations (shaved and shaved/scarified) and for control 2 untreated localizations (shaved and shaved/scarified) were prepared. Only reactions being different to control localizations were valuated for positive skin reactions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all 5 animals
Time point:
other: 24 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal: all 5 animals
Time point:
other: 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal: all 5 animals
Time point:
other: 7 days
Score:
0
Irritation parameter:
edema score
Basis:
animal: all 5 animals
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal: all 5 animals
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal: all 5 animals
Time point:
other: 7 days
Score:
0
Irritant / corrosive response data:
These results were observed both on the shaved skin and on the shaved/scarified skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
No classification as skin irritant.
Executive summary:

The compound CITROWANIL B M 2/585 Nr. 4 has been tested undiluted in a primary skin irritation test on rabbits. Under the conditions of the experiment the following results have been determined:

1. No skin irritation have been observed on any animal till the 72 -hours-value.

2. The index of the primary irritation of the produkt CITROWANIL B M 2/585 Nr. 4 was "0" and could be stated as "non-irritant".

There is no objection for contact with normal human skin.