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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
EC Number:
406-250-0
EC Name:
Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
Cas Number:
72619-32-0
Molecular formula:
C16H13ClF3NO4
IUPAC Name:
methyl 2-(4-{[3-chloro-5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoate
Test material form:
solid
Specific details on test material used for the study:
R Enantiomer of XRD-453 Methyl Ester
Lot # AGR 259823
Purity: 95.7%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania
- Weight: 2.1 to 2.4 kg
- Housing: Individually
- Diet: Purina Certified Rabbit Chow # 5322 (Ralston Purina Co., St. Louis, Missouri), ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least two weeks

ENVIRONMENTAL CONDITIONS
- Animal room was designed to maintain adequate environmental conditions concerning temperature and humidity

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6 (2M + 4F)
Details on study design:
TEST SITE
- Area of exposure: Approximately 2.5 x 2.5 cm
- Type of wrap if used: Gauze patch held in place with non-irritating tape. The gauze patch was covered with a flannel bandage taped to the rabbit

REMOVAL OF TEST SUBSTANCE
- Washing: The wrapping and gauze patch were removed after four hours and the back was wiped with a damp disposable towel to remove any residual test substance
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
- The application sites were graded for erythema and edema within thirty minutes and 24, 48 and 72 hours after patch removal.

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:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of dermal irritation at any time post-treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There were no signs of dermal irritation in the rabbits at any time post-treatment.
Executive summary:

The primary dermal irritation study was conducted on New Zealand White rabbits according to the guideline EPA OPP 81-5. Aliquots of 0.5 ml of undiluted test substance were applied for four hours to the intact skin on the back of six New Zealand White rabbits. There were no signs of dermal irritation at any time post-treatment.