Registration Dossier
Registration Dossier
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EC number: 607-104-0 | CAS number: 225375-65-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-07-30 to 1984-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- Silicophosphonat
- IUPAC Name:
- Silicophosphonat
- Details on test material:
- - Name of test material (as cited in study report): Silicophosphonat
- Substance type: Liquid
- Composition: 39% in water, NaOH
- Date of receipt: not given
- Lot/batch No.: W 760/84
- Expiration date of the lot/batch: stability verified at the end of the test.
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main
- Age at study initiation: not given
- Weight at study initiation: mean 2.4 kg
- Housing: individually in metal cages with mesh walk floors, floor area 40x51 cm
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): 250 mL per animal per day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 30-70 %
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping 15 hours before
- Vehicle:
- water
- Controls:
- other: untreated sites of the same animal
- Amount / concentration applied:
- 0.5 mL undiluted test lest sulution on a 2.5x2.5 cm patch
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3 (1 female, 2 males)
- Details on study design:
- TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: 25 mm x 25 mm
- Type of wrap if used: not given
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and water (1:1) at the end of the exposure period
- Time after start of exposure: 4 hours
NEGATIVE CONTROL: untreated sites of the same animal
SCORING SYSTEM:
Erythema and Edema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe
Calculation of the mean according to 83/467/ECC criteria of July 29th, 1983
(for calculation of the means of erythema and edema only the reading of 24, 48 and 72 hours are used)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- other: 4, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 4, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 4, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- other: 4, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 4, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 4, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No dermal reaction to treatment was observed in any animal throughout the study
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occlusive application of Silicophosphonate to intact rabbit skin for four hours elicited no dermal irritation
- Executive summary:
A study was performed to assess the skin irritation potential of Silicophosphonat to the rabbit. The method followed was that described in OECD Methods for the determination of toxicity. The rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for four days. No dermal reactions were observed in any animal following a single semi-occlusive application of Silicophosphonat to intact rabbit skin for four hours.
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