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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-05-19 to 2010-05-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Remarks:
U.S. FDA

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloro-5-iodobenzoic acid
EC Number:
606-224-0
Cas Number:
19094-56-5
Molecular formula:
C7H4ClIO2
IUPAC Name:
2-chloro-5-iodobenzoic acid
Test material form:
solid: particulate/powder
Details on test material:
white to off-white powder
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: ambient temperature in the dark

In vitro test system

Justification for test system used:
rabbit is a standard species used in dermal irritation studies and is acceptable to regulatory agencies

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
SOURCE ANIMAL- Source: Harlan, Oxford, MI- Sex: female- Age at study initiation (in days): 11 weeks at start of dosing; - Weight at study initiation: 2.1 to 2.3 kilograms at the outset (day 1)- Housing:individually- Diet (e.g. ad libitum):ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period: a minimum of five days prior to dosing ENVIRONMENTAL CONDITIONS - Temperature (°C): 21 to 24 °C - Humidity (%): 28 to 60% (rel. Humidity) - Photoperiod (hrs dark / hrs light):12 hours light/12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL - Amount(s) applied (volume or weight with unit):500 mg of the test item moistened slighly with saline; measured pH4 VEHICLE - Amount(s) applied (volume or weight with unit): approx. 0.3 ml - Lot/batch no. (if required): C764207NEGATIVE CONTROL: noPOSITIVE CONTROL: no
Duration of treatment / exposure:
4 hours
Observation period:
Animals were observed for signs of erythema and edema and the responses scored 30-60 minutes after removal of the patches, 24, 48,72 hours
Number of animals:
3
Details on study design:
TEST SITE - Area of exposure: intact skin, area on the dorsal trunk - % coverage: 5x5 cm - Type of wrap if used: covered with a gauze patch; the trunk was wrapped with an elastic bandage dressing, held with non-irritating tape REMOVAL OF TEST SUBSTANCE - Washing (if done): residual test article was removed using water and gauze - Time after start of exposure: after four hoursOBSERVATION TIME POINTS- Dermal observation: 30-60 minutes and then at 24, 48, 72 hours after each patch removal- Mortality: once daily- Clinical observation: prior to dose administration and then daily- Body weight: prior to dose administrationSCORING SYSTEM: - Method of calculation: Primary irritation index (PII) using scoring by Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 minutes
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30-60 minutes
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30-60 minutes
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30-60 minutes
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30-60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30-60 minutes
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: PII= Summ of erythema and edema scores for 30 -60 min., 24, 48, 72-hour evaluation/ 4evaluation intervals x number of animals
Time point:
other: 30-60 min, 24, 48 and 72 hour
Score:
0.6
Max. score:
8
Other effects:
- Other adverse local effects:no necrosis, no fissuring, no sloughing

Applicant's summary and conclusion

Interpretation of results:
other: "not classified" according CLP
Conclusions:
Under the conditions of the study , the Primary Irritation Index (PII) score was calculated from the erythema and edema score to be 0.6.