Registration Dossier
Registration Dossier
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EC number: 816-285-7 | CAS number: 1263133-33-0
Skin irritation / corrosion
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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nousan-8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 1263133-33-0
- Test material form:
- solid
- Details on test material:
- Purity: 99.4%
Impurities: Not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or test system 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.
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