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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
Study period:
Study completed October 9, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
The test material was stored at room temperature. The Sponsor was responsible for any necessary evaluations related to identity, strengh, purity, composition, stability and method of synthesis of the test material according to 40 CFR 160.105 and 40 CFR 792.105.
The Sponsor was responsible for maintaining a retention sample of the test article.
The test article was administered as reveived from the Sponsor and dispensed fresh on the day of dosing.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Plastic ear tags displaying unique identification numbers were used to individually identify the animals.
Animals were housed individually in suspended stainless steel cages.
Animals room temperature and relative humidity ranges were 66-70°F and 43-49%.
PMI Certified Rabbit Chow was provided ad libitum.
Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.

Upon receipt, animals were acclimated to the laboratory conditions for a minimun of 5 days.
Animals were approximately 11 weeks old and weighted 2,3-2,5 kg at study initiation.
Light timers were set to maintain a 12-hour light-12-hour dark cycle and roon ventilation was set to produce 10-15 air changes-hour.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
Care was taken to avoid abrading the skin during the clipping procedure.
Vehicle:
water
Amount / concentration applied:
0,5g applied
Concentration 100%
Duration of treatment / exposure:
4h exposure period
Observation period:
1 hour after patch removal
24, 48 and 72h after patch application
Number of animals:
3
Details on study design:
The test article was moistened with the appropriate amount of deionized water to form a paste and then administered under the gauze patch. Tha gauze patch was held in contact with the skin at the cut edges with a nonirritating tape.
Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and test area (semi-occlusive binding).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 1
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 1
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
ca. 0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritant / corrosive response data:
The responses were scored according to the Macroscopic Dermal Grading System which is based on Draize, which is the same as the system used in the 404 OECD guideline.
Other effects:
Any unusual observations and/or mortality were recorded.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not classified. Score of 0.25.
Executive summary:

In a primary skin irritation study, performed according the OPPTS Guideline 870.2500, in GLP compliance, 3 New Zealand rabbits were used to assess irritant and/or corrosive potential effect of 2,4 -Dinitroanisole. Each of 3 rabbits received a 0,5g dose of the test article in a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder.

Exposure to DNAN produced a very slight erythema on 2/3 test sites at the 1/hour scoring interval. The dermal irritation resolved completely in the affected animals by the 48 -hour scoring interval.

The Draize's score is 0.25.