Registration Dossier
Registration Dossier
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EC number: 253-057-0 | CAS number: 36483-57-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Japanes test guidelines (2000)
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- EC Number:
- 253-057-0
- EC Name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- Cas Number:
- 36483-57-5
- Molecular formula:
- C5H9Br3O
- IUPAC Name:
- 3-bromo-2,2-bis(bromomethyl)propan-1-ol
- Details on test material:
- Identification: FR-513
Mol. formula: C5H9Br3O
Mol. Weight: 324.92
CAS #: 36483-57-5
Description: White flakes
Batch: 039084 (taken from label)
Composition: Tribromoneopentyl alchohol 97%, Dibromoneopentyl glycol < 0.1%
Storage: At room temperature in the dark
Stability under storage conditions: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Albino Rabbit , New Zealand White (SPF-Quality)
Source: Charles River Deutschland, Kisslegg, Germany
Number of animals: 3 males
Age and body weight: at least 6 weeks old and body weights were at least 1.0 kg.
Housing: Individually in labelled cages with perforated floors.
Acclimatisation: at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory diet
Water: Free access to tap water
Temperature (°C): 21.0 ± 3.0 °C (actual range:16.7-22.4°C)
Humidity (%): 30-70% (actual range 37-74%)
Air changes (per hr): 15
Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The dorsal fur was clipped with electronic clippers
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 gr
- Duration of treatment / exposure:
- 4 hr
- Observation period:
- 1, 24, 48 and 72 hrs after exposure
- Number of animals:
- 3
- Details on study design:
- see attached file on study design
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1-72hr
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1-72hr
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1-72hr
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1-72hr
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1-72hr
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1-72hr
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No skin irritation was caused after 4 hrs exposure to FR-513
There was no evidence of corrosive effect on the skin - Other effects:
- No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
see attached document on tables
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- FR-513 found to be non-irritant to the rabbits under the conditions of the study
- Executive summary:
Primary skin irritation/corrosion with FR-513 in the rabbit was conducted according to the appropriate guidelines of OECD 404 and OPPTS 870.2500. Three rabbits were exposed to 0.5 gr of FR-513, applied onto clipped skin for 4 hr using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hr after exposure.
No skin irritation was caused by 4 hr exposure to FR-513. Hence FR-513 was found to be non-irritant to the rabbits under the conditions of the study.
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