Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Existing in-vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 12 to 19, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study similar to the guideline and under GLP. Only the results of the test on intact skin were taken into account.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- 6 rabbits were treated on abraded and intact skin (each 2 sites per animal) during 24 hours
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid: viscous
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Hill Farm, S. Brunswick NJ
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: Pel1eted Purina Rabbit Chow (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-27 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL at each site
- Concentration: 90% formulation
VEHICLE: none - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2 males and 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2 per application site
- % coverage: 10%
- Type of wrap if used: adhesive-backed gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none, gently wiped clean
- Time after start of exposure: 24 hour after application
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- >= 0 - <= 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Only the results of the intact skin were taken into account.
Any other information on results incl. tables
|
24 hours |
48 hours |
72 hours |
7 days |
||||
|
oedema |
erythema |
oedema |
erythema |
oedema |
erythema |
oedema |
erythema |
Animal 1 |
0/0* |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 2 |
0/0 |
0/1 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 3 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 4 |
0/0 |
0/1 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 5 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 6 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
*site 1/site 2 of intact skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to the skin
- Executive summary:
Six rabbits were dermally exposed to the substance under occlusion for 24 hours. Observations at 24, 48 and 72 hours, as well after 7 days after exposure did not show any signs of irritation. Only the results of intact skin sites were taken into account. The substance is considered not irritating to the skin.
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