Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Jul 2007 - 16 Oct 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
exception: The test article was characterized for composition and purity. However, it was not done under GMP/GLP. It was not characterized for stability.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Remarks:
exception: The test article was characterized for composition and purity. However, it was not done under GMP/GLP. It was not characterized for stability.

Test material

Constituent 1
Chemical structure
Reference substance name:
(2-chloro-5-iodophenyl)(4-fluorophenyl)methanone
EC Number:
619-596-4
Cas Number:
915095-86-2
Molecular formula:
C13 H7 Cl F I O
IUPAC Name:
(2-chloro-5-iodophenyl)(4-fluorophenyl)methanone
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Age: 14 weeks at start of dosing; records of dates of birth for animals used in this study are retained in the Calvert archives. Body weight range: 2.2-2.3 kilograms at the outset (Day 1) of the study. Animal Source: Harlan, Oxford, MI Experimental history: Purpose-bred and experimentally naive at the outset of the study. Identification: Ear tag and cage card. The rabbit is the standard species used in dermal irritation studies and is acceptable to regulatory agencies. The albino rabbit is recommended as the preferred species because of its size, skin permeability and published historical database for dermal irritation assays.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
Each animal received 500 mg of the test material on an intact skin site moistened with distilled water (0.3 ml).
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48, 72h
Number of animals:
3 male
Details on study design:
The test article, IN 00078280, was applied to one site on the clipped dorsal trunk of three male New Zealand White rabbits. The total exposure period was 4 hours. Observations for dermal irritation and corrovisity were recorded for each 30-60 minutes after patch removal and at 24, 48 and 72 hours after unwrap. Grdaing of irritation was according to the method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A primary Irritation Index (PII) will be calculated from the erytherma and edema scores according to the following formula:

PII= Sum of erytherma and edema scores for the 1, 24, 48 and 72-hour evaluation
--------------------------------------------------------------------------------------------------
4 evaluation intervals x number of animals

The maximum possible score is 8.0. The PII of the test item will be used to classify the test article as follows:

Primary Irritation index (PII) Irritation Rating
----------------------------------------------------------
0 non-irritating
0.1-2.0 Slightly Irritating
2.1-5.0 Moderately Irritating
5.1-8.0 Severly Irritating

Applicant's summary and conclusion

Interpretation of results:
other: not classified acc. CLP
Conclusions:
The test article, BI 10773, was not found to be irritant to the skin of rabbits with a Primary Irritation Index score of 0.
Executive summary:

A. Title Primary Dermal Irritation Study of IN 00078280 in Rabbits

B. Objective The purpose of this study was to determine the potential irritant and/or corrosive effects of IN 00078280 on the skin of rabbits.

C. Methods The test article, IN 00078280, was applied to one site on the clipped dorsal trunk of three male New Zealand White rabbits. The total exposure period was 4 hours. Observations for dermal irritation and corrosivity were recorded for each site 30-60 minutes after patch removal and at 24, 48 and 72 hours after unwrap. Grading of irritation was according to the method of Draize.

D. Results The Primary Irritation Index (PII) was calculated and determined to be 0.

E. Conclusion Under the conditions of this study, IN 00078280, was found to be a nonirritant to the skin of rabbits with a Primary Irritation Index score of 0.