Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 20 October 2015 and 18 January 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Lot/Batch number 1004R17501
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and humidity
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS:
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA.
- Age at study initiation: ~27 weeks
- Weight at study initiation: 2.9 - 3.3 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 October 2015 To: 23 October 2015
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 - Duration of treatment / exposure:
- 72 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx 6 sq cm
- % coverage: 100
- Type of wrap if used: non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize technique
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: ALL
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: All
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: all
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: all
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: all
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: all
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
Any other information on results incl. tables
Results Table:
| No. of animals | Dermal responses (time post exposure) | Erythema | Edema | Addiitonal dermal observations |
| Four-hour exposure | ||||
| 3 | 1 hr | Absent to very slight | Absent | NA |
| 3 | 24 hr | Absent | Absent | NA |
| 3 | 48 hr | Absent | Absent | NA |
| 3 | 72 hr | Absent | Absent | NA |
| Systemic Observations | No abnormal physical signs were observed | |||
| Body weights | One animal gained bodyweight by study termination and two animals' weight remained the same | |||
| Conclusion | RC 14156 is not a dermal irritant | |||
NA = Not Applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- RD 14156 is not a dermal irritant
- Executive summary:
Objective:
To determine the irritant or corrosive effects, if any, of a test article when applied to the skin of a rabbit. This study was designed to comply with the standards set forth in the current OECD Guideline for Testing of Chemicals, Number 404 Acute Dermal Irritation/Corrosion.
Method Synopsis:
Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (one male - two females) were dosed dermally with RD 14156. The test article (0.5 g) was applied dermally to one intact site per rabbit and wrapped with a semi-occlusive dressing. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Erythema and edema were scored at 1, 24, 48 and 72 hours. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Animals were observed for mortality, toxicological and pharmacological effects at each dermal observation period. Body weights were recorded pretest and at termination.
Summary:
No. of animals Dermal responses (time post exposure) Erythema Edema Addiitonal dermal observations Four-hour exposure 3 1 hr Absent to very slight Absent NA 3 24 hr Absent Absent NA 3 48 hr Absent Absent NA 3 72 hr Absent Absent NA Systemic Observations No abnormal physical signs were observed Body weights One animal gained bodyweight by study termination and two animals' weight remained the same Conclusion RC 14156 is not a dermal irritant NA = Not Applicable
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