Registration Dossier
Registration Dossier
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EC number: 690-995-3 | CAS number: 756-12-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- MTDID 20422
- IUPAC Name:
- MTDID 20422
- Reference substance name:
- 1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)butan-2-one
- EC Number:
- 690-995-3
- Cas Number:
- 756-12-7
- Molecular formula:
- C5 F10 O
- IUPAC Name:
- 1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)butan-2-one
- Test material form:
- other: Liquid
- Details on test material:
- Name of test material (as cited in study report: MTDID 20422
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: 99.99%
- Purity test date: 02/16/2011
- Expiration date of the lot/batch: 02/16/2013
- Storage condition of test material: At room temperature in the dark.
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 1
- Expiration date of the lot/batch: 05 June, 2019
- Purity test date: 05 June, 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, dosed neat
FORM AS APPLIED IN THE TEST: Neat
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle, France
- Age at study initiation: 21-22 weeks old
- Weight at study initiation: 3490-3727 grams
- Housing: On arrival and following assignment to the study, animals were housed individually in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) equipped with water bottles. The room(s) in which the animals were kept were documented in the study records. Each cage was clearly labeled.
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 Teklad®, Mucedola, Milanese, Italy) was provided once daily throughout the study. In addition, hay (TecniLab-BMI BV, Someren, The Netherlands) was available during the study period. The feed was analyzed by the supplier for nutritional components and environmental contaminants. Results of the analysis were provided by the supplier and are on file at the Test Facility. It is considered that there were no known contaminants in the feed that would interfere with the objectives of the study.
- Water (e.g. ad libitum): Municipal tap-water was freely available to each animal via water bottles. Periodic analysis of the water was performed, and results of these analyses are on file at the Test Facility. It is considered that there were no known contaminants in the water that would interfere with the objectives of the study.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 70-73
- Air changes (per hr): At least 10 an hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10 October, 2017 To: 23 October, 2017
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other:
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
VEHICLE : None, dosed neat
NEGATIVE CONTROL : None
POSITIVE CONTROL : None - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Flank
- % coverage: 2 x 3 cm
- Type of wrap if used: The test article was covered with a metalline patch mounted on micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with tap water
- Time after start of exposure: 4 hours after application.
OBSERVATION TIME POINTS
Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Four hours exposure to 0.5 mL of the test article resulted in very slight edema in the treated areas of two of the three rabbits. The skin irritation resolved within 24 hours after exposure in these animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study (PII= 0.22), the test article is not a skin irritant.
- Executive summary:
The acute dermal irritation potential of the test article was evaluated in three female rabbits. The study was conducted according to OECD 404 (2015) in compliance with OECD GLP principles. Three female rabbits were exposed to 0.5 mL of the test article by application onto clipped skin. The test article was covered with a metalline patch mounted on micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage. Following a 4 hour exposure to the test article, the site was washed with tap water and skin reactions were assessed at 1, 24, 48 and 72 hours. Four hours exposure to 0.5 mL of the test article resulted in very slight edema in the treated areas of two of the three rabbits. The skin irritation resolved within 24 hours after exposure in these animals. Based on the results of the study (PII= 0.22), the test article is not a skin irritant.
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