Registration Dossier
Registration Dossier
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EC number: 473-390-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries. 12 Nousan, Notification No. 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 473-390-7
- EC Name:
- -
- Cas Number:
- 1093615-61-2
- Molecular formula:
- C7F15NO
- IUPAC Name:
- 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine; 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,2,2,3,3,3-heptafluoropropyl)morpholine
- Reference substance name:
- MTDID 7145
- IUPAC Name:
- MTDID 7145
- Details on test material:
- - Name of test material (as cited in study report): MTDID 7145
- Molecular weight (if other than submission substance): 399
- Substance type: Clear colorless liquid
- Physical state: liquid
- Analytical purity: ~94.5%
- Lot/batch no.: Batch 142072:43
- Expiration date of the lot/batch: 30 December 2007
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: Test substance is volatile. pH: 7.2. Specific gravity: 1.8
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- sex : Male
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing:- Diet (e.g. ad libitum): ~100 g/day pelleted diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21 C
- Humidity (%): 43-69%
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): applied undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24,48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 150 square centimeters
- % coverage: 2x3 cm Metalline patch mounted on Micropore tape wrapped around abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours after application
SCORING SYSTEM: 0-4 erythema and eschar formation; 0-4 edema formation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 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:
- 24/48/72 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:
- 24/48/72 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of skin irritation, corrosion, skin coloring or toxicity was observed. Scores of 0 were noted at all timepoints.
Any other information on results incl. tables
No signs of skin irritation, corrosion, skin coloring or toxicity was observed. Scores of 0 were noted at all timepoints.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD GHS and EU
- Conclusions:
- No skin irritation was caused by 4 hours exposure to the test article.
- Executive summary:
A primary skin/irritation study was performed with the test article according to OECD Study Guideline No. 404 (2002). Three New Zealand albino rabbits (male) were exposed to 0.5 ml (undiluted) of the test article by application onto clipped skin using a semi-occlusive dressing. The exposure periods were 3 minutes, 1 hour and 4 hours, respectively. Skin reactions were assessed at least once daily for 4 days after treatment. No skin irritation of any kind was caused by up to 4 hours of exposure to the test article. Neither, was there any lethality or any indication of systemic toxicity during testing period. Based on these results test article does not have to be classified and has no obligatory labeling requirement of skin irritation according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and EC criteria for classification and labelling.
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