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EC number: 207-012-7 | CAS number: 422-05-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 02 - 12 September 1989
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize Test Guidelines
- Version / remarks:
- Draize Testing method (Draize JH et al., Pharm. Exp. Ther. 82: 377-390, 1944; Draize JH, Assoc. Food Drugs Officials of the United States: 46-49, Topeka Kansas, 1965) as prescribed by the FDA (in The Federal Register 38 No. 187 §15000.41, USA).
- Deviations:
- yes
- Remarks:
- concentration of test substance was not mentioned
- Principles of method if other than guideline:
- - Principle of test: the principles of the Draize primary skin irritation test in rabbits were followed
- Short description of test conditions: the skin on the backs of rabbits is shaved with four quadrants being assigned per rabbit: 2 abraded and 2 intact sites. Two test substances were applied per rabbit yielding one abraded and one intact site per rabbit per test substance. A volume of 0.5 mL of each test substance was applied to each site. After 24 hours of unoccluded exposure, all test sites were gently washed with distilled water, and graded for erythema and edema at 1 and 48 hours after washing.
- Parameters analysed / observed: Clinical observations were made on the day of administration, and daily thereafter. Erythema and edema were graded according to the Draize scales. A Primary Irritation Index was generated by averaging of the sums of the 1 and 48 hour grades for erythema and edema per test substance. - GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,2,3,3,3-pentafluoropropanol
- EC Number:
- 207-012-7
- EC Name:
- 2,2,3,3,3-pentafluoropropanol
- Cas Number:
- 422-05-9
- Molecular formula:
- C3H3F5O
- IUPAC Name:
- 2,2,3,3,3-Pentafluoropropan-1-ol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Japanese
- Remarks:
- JW-NIBS / Rabiton
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rabiton Institute, Inc., Japan
- Age at study initiation: 3.5 - 4 months
- Weight at study initiation: 2.00 - 2.37 kg
- Housing: metal cages
- Diet: NRT-1s from Nisseiken, Tokyo, Japan, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 - 60%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 02 September 1989 To: 12 September 1989
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted, not further specified - Duration of treatment / exposure:
- 24 h
- Observation period:
- 3 days, not further specified
Reading time points: 1 h and 48 h corresponding to 24 and 72 hour reading time points according to current guideline - Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: not specified
- Type of wrap if used: sponge and surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with distilled water
- Time after start of exposure: 24 h
OBSERVATION TIME POINTS
- 1 (after the 24 h exposure) and 48 h after washing
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 unabraded sites
- Time point:
- other: 24/72
- Score:
- ca. 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: No data after 72 h scoring
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 unabraded sites
- Time point:
- other: 24/72
- Score:
- ca. 0.58
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: No data after 72 h scoring
- Irritant / corrosive response data:
- The Primary Irritation Index (PII) was calculated based on Draize scoring. The test material is considered a moderate skin irritant based on the PII.
PII scores of < 2 are slightly irritating, scores of 2 - 6 are moderately irritating, and scores of > 6 are strongly irritating.
Mean of the Intact erythema plus edema 24 h scores: 2.50
Mean of the Abraded erythema plus edema 24 h scores: 4.17
Mean of the Intact erythema plus edema 48 h scores: 1.67
Mean of the Abraded erythema plus edema 48 h scores: 2.50
Primary Irritation Index (PII) = Average of these 4 Means: 2.71 - Other effects:
- - Other adverse local effects: On abraded sites necrosis was observed, not further specified
- Other adverse systemic effects: Throughout the test period, no other abnormalities were noted in any animals
Any other information on results incl. tables
Table 1. Intact Skin Reported Only
Reading |
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
|
No experimental data available for the 24 h time reading; however for calculation of mean (x̅) scores, the reported 1 h values were used as 24 h, since the time reading was 1 h after the 24 h exposure. |
||||||||||||
24 h |
2 |
2 |
3 |
2 |
1 |
0 |
1 |
0 |
2 |
1 |
1 |
0 |
72 h |
3 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
x̅ of 24 +72 h |
2.5 |
1.5 |
2.5 |
1.5 |
0.5 |
0 |
0.5 |
0 |
2.5 |
0.5 |
0.5 |
0 |
Ery = Erythema
Oed = Oedema
Table 2. Abraded Skin Reported Only
Reading |
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
Ery |
Oed |
|
No experimental data available for the 24 h time reading; however for calculation of mean (x̅) scores, the reported 1 h values were used as 24 h, since the time reading was 1 h after the 24 h exposure. |
||||||||||||
24 h |
4 |
2 |
4 |
2 |
2 |
0 |
2 |
1 |
4 |
1 |
2 |
1 |
72 h |
4 |
1 |
2 |
1 |
0 |
0 |
1 |
0 |
4 |
0 |
1 |
1 |
x̅ of 24 +72 h |
2.5 |
1.5 |
2.5 |
1.5 |
0.5 |
0 |
0.5 |
0 |
2.5 |
0.5 |
0.5 |
0 |
Ery = Erythema
Oed = Oedema
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- This study was not performed according to current OECD guideline 404 as the treatment lasted 24 hours and skin irritation scores were evaluated after 1 hour and 48 hours after removing the test substance. Skin irritation was observed in all 6 animals. In 3 of 6 animals the skin irritation was not reversible. Thus, a final conclusion on the skin irritation potential of the test substance cannot be made.
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