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Registration Dossier
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EC number: 432-070-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 27, 1997 - July 03, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Batch number: 971108
Description: white crystalline solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Sulzfeld
- Age at study initiation: no data available
- Weight at study initiation:
animal #1: 2623 g (at the start) ; 2677g (at conclusion of the test)
animal #2: 2613g (at the start); 2665g (at conclusion of the test)
animal l#3: 2863g (at the start), 2954g (at conclusion of the test)
- Housing: Altromin Type S8/15, granulated soft wood bedding, Batch 181297
- Diet (e.g. ad libitum): Altromin 2123, standard diet for rabbits, Batch 220198/1404
- Water (e.g. ad libitum): tap water (municipal supply), Makrolon bottles, daily change
- Acclimation period: 6 weeks before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 35-45%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light is set to give a cycle of 12 hours light and 12 hours dark, light from 6.30 a.m. - 6.30 p.m.
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test article
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): the gauze patch with the test article on it was moistened with distilled water and then applied - Duration of treatment / exposure:
- The administration was performed on January 15, 1998, 8.39 - 8.41 a.m.
Exposition period: 4 hours - Observation period:
- Animals were examined for sings of erythema and oedema and the response scored at 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 4x5 cm on the left and on the right side of the spine (one area was used as control)
- % coverage: 2.5x3.5 cm (gauze patch, two layers)
- Type of wrap if used:overed with aluminium foil (3x4 cm) which was held in contact with the skin by occlusvie dressing (Lohmann GmbH & Co. , Neuwied)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application area was washed with water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Grading of skin reaction:
Erythema and Eschar formation value
No erythema .............................................................................0
Very slight erytheina (barely perceptible) ........................... 1
Well defined erythema .............................................................2
Moderate to severe erythema................................................ 3
Severe erythema (beet redness) to eschar formation
preventing grading of erythema............................................4
Oedema formation
No oedema ...............................................................................0
Very slight oedema (barely perceptible)..............................1
Slight oedema (edges of area well defined by definite raising....2
Moderate oedema (raised approximately 1 millimetre) .............. 3
Severe oedema (raised more than 1 millimetre
and extending beyond area of exposure)......................................4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- see "results and discussions"
- Other effects:
- The control skin areas of the animals didn`t show any alterations at any observation time.
The treated skin areas showed only a slight erythema one hour after patch removal in two animals.
Other signs of irritation were not observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The application of 0.5g of the test item to shaved dorsal area of trunk of albino rabbits caused only a slight erythema on hour after patch removal in two animals. No systemic toxic effects were observed.
- Executive summary:
The acute dermal irritation/corrosion of the test item was tested in three albino rabbits.
The test article was applied in a single dose of 0.5 g to a shaved dorsal area of trunk and covered with agauze patch and aluminium foil which was held in contact with the skin by an occlusive dressing. Exposure duration was 4 hours. Thereafter residual substance was removed using water.
Animals were examined for mortality, clinical signs and signs of irritation response 60 minutes, 24, 48, 72 hours after patch removal.
Only a slight erythema was observed one hour after patch removal in two animals. No animal died or showed clinical signs in the course of testing.
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