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EC number: 812-739-3 | CAS number: 157357-30-7
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 12 to June 26, 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study conducted according to OECD test Guideline No. 404. The study was fully reliable (Klimisch score = 1), however the reliability score was lowered to 2 which is the maximum score for read-across. The supporting substance is considered adequate for read-across purpose (see IUCLID section 13 for additional justification). Environmental conditions were not reported but assumed to be adequate because it is a GLP study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- some details missing on test animals and environmental conditions, but assumed to be adequate because it is a GLP study.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-pentylcyclopentan-1-ol
- EC Number:
- 283-187-3
- EC Name:
- 2-pentylcyclopentan-1-ol
- Cas Number:
- 84560-00-9
- IUPAC Name:
- 2-pentylcyclopentanol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ST 22 C 95
- Physical state: clear liquid
- Storage conditions: ambient temperature and humidity in the container in which it was received
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Trevanor Farm, Mainesburg, PA. USDA # 23-A-055.
- Age at study initiation: no data.
- Weight at study initiation: no data.
- Housing: individually housed in suspended stainless steel wire-mesh cages.
- Diet: Agway High Fiber Rabbit feed and Alfalfa cubes, ad libitum.
- Water: city water ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
No data
IN-LIFE DATES:no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations within 30-60 minutes after patch removal and at 24, 48 and 72 hours, and on Day 4, 7 and 14 after exposure.
- Number of animals:
- 3 (Male or Female)
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk, 6 cm² approximately
- Type of wrap if used: Patch held in place with non-irritating tape and covered with gauze which was then overwrapped with Elastikon tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Flaking skin in 2/3 at 72hrs; blanched skin in 1/3 at the three time points
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- There was well-defined erythema and very slight oedema in 3/3 animals tested four hours post dosing. At 24 hours, all animals had well-defined erythema; 2 animals had very slight oedema, one animal had well-defined oedema.
At 48 and 72 hours there was well-defined erythema with one animal having blanched skin at the test site. Very slight oedema was noted in 2 animals, one animal had well-defined oedema.
On day 4, all animals had well-defined erythema and very slight oedema. One animal had blanched and flaking skin at the test site and one animal had flaking skin.
On day 7, 2 animals had very slight erythema, one of which had blanched skin. One animal had no erythema. All animals had flaking skin at the test site. There was no oedema noted.
On day 14, there was no erythema or oedema noted. All three animals had flaking skin. - Other effects:
- All animal appeared normal during the observation period.
Any other information on results incl. tables
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
2 / 2 / 2 |
1 / 1 / 1 |
24 h |
2 / 2 / 2 |
1 / 2 / 1 |
48 h |
2B / 2 / 2 |
1 / 2 / 1 |
72 h |
2B / 2 / 2 |
1 / 2 / 1 |
4 d |
2BF / 2F / 2 |
1 / 1 / 1 |
7 d |
1BF / 1F / 0F |
0 / 0 / 0 |
14 d |
0F / 0F / 0F |
0 / 0 / 0 |
Average 24h, 48h, 72h |
2.00 / 2.00 / 2.00 |
1.00 / 2.00 / 1.00 |
Reversibility*) |
c. |
c. |
Average time for reversion |
14 days |
7 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
F = Flaking skin
B = Blanched skin at test site
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test material induced irritation that persisted to the end of the observation period (flaking skin). The test item is therefore classified as category 2 irritant according to Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test material was dermally applied on the clipped skin of the dorsal surface of the trunk of 3 New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days for edema and erythema.
Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch and on day 4, 7 and 14.
The scores calculated for each animal tested within 3 scoring times (24, 48 and 72 hrs) were 2.0/2.0/2.0 for erythema and 1.0/2.0/1.0 for oedema.
All 3 animals had flaking skin on Day 14.
Under the test conditions, the test material induced irritation that persisted to the end of the observation period (flaking skin).
Therefore, the test material requires a classification as irritating to skin H315, according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as reversibility of skin lesions was not achieved at the end of the 14-day observation period.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
The supporting substance is considered adequate for read-across purpose (see IUCLID section 13 for justification).
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