Registration Dossier
Registration Dossier
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EC number: 230-898-1 | CAS number: 7360-53-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline- and GLP-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Aluminium triformate
- EC Number:
- 230-898-1
- EC Name:
- Aluminium triformate
- Cas Number:
- 7360-53-4
- Molecular formula:
- CH2O2.1/3Al
- IUPAC Name:
- aluminium triformate
- Details on test material:
- Test article: Altriform CFD
Chemical name: Aluminiumtriformiat
Batch No.: 46799/01
Activity: approx. 97%
Description: White powder
Stability: 12 months
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb:HM(SPF)-Littlerussian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.8, 2.9, 3.0 kg
- Housing: individual caging in PPO cages
- Diet (e.g. ad libitum): Altromin 2123
- Water (e.g. ad libitum): domestic quality drinking water acidified with HCl to pH 2.5
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3 °C
- Humidity (%): 55 % +/- 15 %
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with an electric clipper
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test article per animal and test site, 2 test sites per animal, moistened with 0.1 mL each
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm per test site
- Type of wrap if used: Gothaplast tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with mild soap and lukewarm water
SCORING SYSTEM:
Reading 1, 24, 48, and 72 hours after termination of exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- 1, 24, 48 and 72 hours after termination of exposure the animals showed no skin reaction at all.
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the directive of the EEC commission 98/98/EC of May 19th, 2000 Aluminiumtriformiat, Batch No. 46799/01, shall not be classified as skin irritating.
- Executive summary:
The primary skin irritant effect of Aluminiumtriformiat was investigated according to the method recommended in the OECD Guideline No. 404, "Acute Dermal Irritation/Corrosion", 1992 and EEC Guideline B.4 "Acute Toxicity (Skin Irritation)", Jan. 1997.
Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure.
No skin reactions were observed at the rabbits.
Under the experimental conditions the mean score for erythema was 0.0 and for oedema 0.0.
According to the directive of the EEC commission 98/98/EC of May 19th, 2000 Aluminiumtriformiat, Batch No. 46799/01, shall not be classified as skin irritating.
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