Registration Dossier
Registration Dossier
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EC number: 800-433-2 | CAS number: 1016636-76-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 April to 01 June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- Batch No.: E010013971
Purity: 98.52%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.25 to 2.69 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): Free access to food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- First animal: 3 minutes, 1 hour and 4 hours
Additional two animals: 4 hours - Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm*2.5 cm
- % coverage: Each patch was secured in position with a strip of surgical adhesive tape.
- Type of wrap if used: To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize score system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritant / corrosive response data:
- 3-Minute and 1-Hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.
A single 4-Hour, semi-occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation. - Other effects:
- All animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Individual Skin Reactions Following 4-Hour Exposure
Observation period (hours) |
Rabbit No. |
|||||
73141Male |
73148 Male |
73220 Male |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item was not classified as an irritant according to GHS and EC CLP 1272/2008.
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