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EC number: - | CAS number: -
- 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:
- Between 18 May and 08 June 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 404 without any deviation. The substance is adequately identified, but some data on composition is missing. Therefore validation applies with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2009-09-03 / Signed on 2009-12-10
Test material
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 1]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 1]
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 2]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 2]
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 3]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 3]
- Reference substance name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 4]
- Molecular formula:
- C12 H22 O2
- IUPAC Name:
- (2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 4]
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless translucent liquid
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- Date received: 10 May 2010
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe).
- Weight at study initiation: 2.15 - 2.77 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SDS - C15), ad libitum
- Water: tap-water (from public system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30- 70 %
- Air changes: fifteen changes per hour
- Photoperiod: 12 hours light/12 hours dark.
IN-LIFE DATES: From 18 May to 08 June 2010.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test item was applied as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).
- Number of animals:
- 3 females
- Details on study design:
- PRETEST
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
TEST SITE
- Area of exposure: Undamaged skin area of one flank of each animal
- Type of wrap if used: Patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).
SCORING SYSTEM:
- Method of calculation: Skin irritant reaction was scored as per Draize scale according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- - A well defined erythema, associated with a very slight to slight oedema, was noted on the treated area of all animals, 24 hours after the patch removal.
- The erythematous reaction was totally reversible between days 2 and 7 and the oedematous reaction was totally reversible between days 2 and 5.
- A slight dryness was noted from day 2, day 4 or day 5 and was totally reversible on day 13 in one animal and remained on day 14 (last day of the study) in the two others. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Individual and mean skin reactions/Erythema - Eschar formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A0222/Female |
A0243/Female |
A0244/Female |
||
Erythema/Eschar formation |
1 h |
1 |
2 |
2 |
24 h |
2 |
2 |
2 |
|
48 h |
0 |
2 |
2 |
|
72 h |
0 |
1 |
1 |
|
Day 4 |
- |
1 |
0 |
|
Day 5 |
- |
1 |
0 |
|
Day 6 |
0 |
1 |
0 |
|
Day 7 | 0 | 0 | 0 | |
Total (24, 48 and 72 hours) |
2 | 5 | 5 | |
Mean (24, 48 and 72 hours) |
0.7 | 1.7 | 1.7 |
Table 7.3.1/2: Individual and mean skin reactions/Oedema formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A0222/Female |
A0243/Female |
A0244/Female |
||
Oedema formation |
1 h |
1 |
2 |
2 |
24 h |
2 |
2 |
1 |
|
48 h |
0 |
2 |
1 |
|
72 h |
0 |
1 |
0 |
|
Day 4 |
- |
1 |
0 |
|
Day 5 |
- |
0 |
0 |
|
Day 6 |
0 |
0 |
0 |
|
Day 7 | 0 | 0 | 0 | |
Total (24, 48 and 72 hours) |
2 | 5 | 2 | |
Mean (24, 48 and 72 hours) |
0.7 | 1.7 | 0.7 |
Note:
A0222: slight dryness days 2 & 3, between day 6 and day 14
A0243: slight dryness day 5, day 6, between day 8 and day 10 day 13 & day 14; dryness day 7
A0244: slight dryness between day 4 and day 10
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Annex I of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.
- 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 item was applied on an undamaged skin area of the flank of 3 female New Zealand White rabbits. On the other flank an untreated area was served as the control. Test sites were covered with a semi-occlusive dressing for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
A well defined erythema, associated with a very slight to slight oedema, was noted on the treated area of all animals, 24 hours after the patch removal. The erythematous reaction was totally reversible between days 2 and 7 and the oedematous reaction was totally reversible between days 2 and 5. A slight dryness was noted from day 2, day 4 or day 5 and was totally reversible on day 13 in one animal and remained on day 14 in the two others.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.7 / 1.7 / 1.7 for erythema and 0.7 / 1.7/ 0.7 for oedema.
Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Annex I of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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