Registration Dossier
Registration Dossier
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EC number: 407-870-4 | CAS number: 97384-48-0 CITROWANIL B
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP; Study according to OECD-Guideline of Mai 1981 lack of data on the purity / quality of the sample tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- CITROWANIL B M 2/585 Nr. 4, clear fluid
- IUPAC Name:
- CITROWANIL B M 2/585 Nr. 4, clear fluid
- Details on test material:
- Citrowanil B
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Five adult White New Zealands with the average weight of 2.5 kg have been used for the procedure.
The animals were housed in single cages and were fed with a standard laboratory diet for rabbits (Altromin/Lage) and were watered ad libitum.
The room temperature was kept constantly at 18 °C +/- 2 °C, the relative humidity 50 - 60 % and daily illumination time was 12 hours.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml test substance were administered to skin by means of a 2.5 cm² cellulose patch.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 hours, 72 hours and 7 days
- Number of animals:
- 5
- Details on study design:
- Primary skin irritation was tested by the patch method on shaved and scarified skin of albino rabbits.
The animals were fixed in an immobilisation cage and the patch by means of leucoplast. All the trunk of the animal was enwrapped into a rubber cloth for 24 hours in order to delay evaporation of etheric substances.
After 24 hours the bandage was removed and local reaction was classifid by points. Readings were repeated 72 hours post application and the final score was the average of 24 and 72 hours reading. After 7 days localizations were controlled finally.
For reproduction 2 treated localizations (shaved and shaved/scarified) and for control 2 untreated localizations (shaved and shaved/scarified) were prepared. Only reactions being different to control localizations were valuated for positive skin reactions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: all 5 animals
- Time point:
- other: 24 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: all 5 animals
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: all 5 animals
- Time point:
- other: 7 days
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: all 5 animals
- Time point:
- other: 24 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: all 5 animals
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: all 5 animals
- Time point:
- other: 7 days
- Score:
- 0
- Irritant / corrosive response data:
- These results were observed both on the shaved skin and on the shaved/scarified skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- No classification as skin irritant.
- Executive summary:
The compound CITROWANIL B M 2/585 Nr. 4 has been tested undiluted in a primary skin irritation test on rabbits. Under the conditions of the experiment the following results have been determined:
1. No skin irritation have been observed on any animal till the 72 -hours-value.
2. The index of the primary irritation of the produkt CITROWANIL B M 2/585 Nr. 4 was "0" and could be stated as "non-irritant".
There is no objection for contact with normal human skin.
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