Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Purity: 99.4%
Impurities: Not reported

Test animals

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc. Mocksville, NC
- Age at study initiation: Young adult
- Weight at study initiation: 2131 - 3503 g
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. A toy was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): approximately 150 grams/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 or 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 53-68%
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.67 g (75% w/w mixture)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: 1 in x 1 in 4-ply gauze applied to test site and entire trunk wrapped with semiocclusive 3-inch Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleansed residual test substance
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
For animal 1: immediately after removal, 30-60 mins, 24 hr, 48 hr, and 72 hr
For animals 2 & 3: 30-60 mins, 24 hr, 48 hr, and 72 hr

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There was no dermal irritation observed at any treated dose site during the study.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application in accordance with OPPTS 870.2500 and OECD 404.

The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and then applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation immediately after patch removal and/or at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no irritation observed at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.

All animals appeared active and healthy and gained body weight during the study. There were no clinical signs observed. There was no dermal irritation observed at any treated dose site during the study.