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EC number: 268-706-3 | CAS number: 68133-79-9
- 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:
- key study
- Study period:
- April 18, 1991-May 14, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Hazardous Substances Act, CFR 16, Section 1500.41
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
- EC Number:
- 268-706-3
- EC Name:
- 2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
- Cas Number:
- 68133-79-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Buckshire Corp. Perkasie, Pennsylvania 18944, USA
- Housing: Elevated stainless steel with wire mesh flooring, 1 rabbit per cage
- Diet (e.g. ad libitum): Wane 15% Rabbit Ration ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21 degrees C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: April 29, 1991 To: May 14, 1991
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one site was left intact, the other was abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, deionized water
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
30-60 minutes after end of exposure, 24 and 72 hrs, day 7 and 14
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/72 hrs
- Score:
- 4.12
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/72 hrs
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24/72 hrs
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24/72 hrs
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24/72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24/72 hrs
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Observations were reported at 24 and 72 hrs post exposure.
- Irritant / corrosive response data:
- All animals showed erythema and edema formation (highest score of 3) at the 24 and 72 hr observations on both intact and abraded skin. All animals also showed edema formation (highest score of 2) at the 24 and 72 hr observations on both intact and abraded skin. All but one animals showed denuded skin and/or exfoliation at the 14 day observation on both intact and abraded skin. No edema was seen on any animal at the day 14 observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- None of the 6 rabbits exhibited eschar formation on day 14 of the observation period. None of the reaction that typify skin corrosive, as noted in the ECHA Guidance, including ulcers, bleeding, bloody scabs, skin discoloration/blanching, alopecia, or hyperkeratosis were reported in any of the animals, and the effects of apritone on the skin were clearly reversible in this study. The test substance is therefore classified as a skin irritant.
- Executive summary:
Bioresearch (1991) performed a test for skin corrosion/irritation following the procedures specified in USA Federal Hazardous Substances Act (16CFR 1500.41). Accordingly, Bioresearch (1991) applied apritone to the clipped skin on both sides of the bodies New Zealand White rabbits (n=6). The surface of the skin on one side of each rabbit was abraded through the stratum corneum without disturbing the dermis or causing bleeding, and the skin on the other side was left intact before applying the test article (0.5 ml apritone, neat, to each side). A gauze patch (1 in.2; 6.45 cm2) was then applied to each site of exposed skin, and an occlusive bandage was wrapped around the trunk of each animal and secured with elastic tape. The tape, bandage and gauze were removed after a 24-hour exposure period, and the sites were wiped with deionized water. The sites were scored, using the Draize method approximately 24 hours and again 72 hours after apritone was applied to the skin (i.e., 30 to 60 minutes and again 48 hours after patch removal).
Bioresearch (1991) presented the primary skin irritation scores of each rabbit. Two of the 6 rabbits scored 3 (moderate to severe erythema ) for erythema/eschar formation at the 24-hour (intact and abraded skin) and 72-hour (abraded skin only) observation points. All other scores were 2 (well defined erythema). None of the rabbits scored 4 (severe erythema to eschar formation preventing grading of erythema) for erythema/eschar formation at either observation point.
One rabbit scored 1 (very slight, barely perceptible) for edema of both intact and abraded skin and another rabbit scored 1 only on the intact skin at the 72-hour observation point. All of the other scores were 2 (slight edema, edges of are well defined by definite raising) at both the 24-hour and 72-hour observation points.
Bioresearch calculated the average erythema/eschar formation scores and edema scores across the 6 rabbits for both intact skin and abraded skin, and then calculated a primary skin irritation index (PII) based on these averages, in accordance with 16CFR 1500.41. Thus, Bioresearch (1991) reported an overall PII of 4.12 for apritone from the results of this study. The PII is 4.08 if only the averages for abraded skin are excluded from the calculation.
The highest average individual scores for were 3 for erythema/eschar formation (in two of the six rabbits) and 2 for edema (in intact skin of 5 of the six rabbits at the 24-hour observation point; in intact skin of 4 of the six rabbits at the 72-hour observation point).
Bioresearch examined and scored the exposed skin again 7-days and 14 days after apritone had been applied, because signs of irritation persisted at the 72-hour observation period. One rabbit scored 1 (very slight, barely perceptible) for edema, and that score was only for the 7-day observation point and was the same for the intact and abraded skin of that single rabbit. One rabbit exhibited remnants of eschar formation on observation day 7, although no score was given for erythema/echar formation in this animal, most probably because the eschar observed was not accompanied by evidence of erythema. All of the other scores were 0 for both erythema/eschar formation and edema at both the 7-day and 14-day observation points.
However, Bioresearch (1991)These authors also noted the following:
- Observation Day 7
- Exfoliation of intact and abraded skin in 4 of 6 animals
- Exfoliation and denudation only on abraded skin in 1 of 6 animals
- Eschar formation in intact and abraded skin in 1 of 6 animals
- Observation Day 14
- Exfoliation of intact and abraded skin in 2 animals
- Exfoliation of intact skin and denudation of abraded skin in 1 animal
- Exfoliation and denudation of both intact and abraded skin in 1 animal
- Denudation of both intact and abraded skin in 1 animal
None of the 6 rabbits exhibited eschar formation on day 14 of the observation period.
None of the reaction that typify skin corrosive, as noted in the ECHA Guidance (2017b), including ulcers, bleeding, bloody scabs, skin discoloration/blanching, alopecia, or hyperkeratosis were reported in any of the animals, and the effects of apritone on the skin were clearly reversible in this study.
[1]ECHA (2017b), see Section 3.2.1 Definitions for classification for skin corrosion/irritation, page 271; see also OECD TG 404, Paragraph #23 page 4; see also the U.S. OSHA Hazard Communication Standard (HCS 2012, e.g.,https://www.schc.org/assets/docs/ghs_info_sheets/Skin%20Corrosion%20%20Irritation%20(Final%202018-03).pdf) and the Definitions Chapter 6 of the UN International Labour Organisation (ILO) draft Integrated Proposal (https://www.ilo.org/legacy/english/protection/safework/ghs/ghsfinal/ghsc06.pdf).
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