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EC number: 613-782-9 | CAS number: 65355-32-0
- 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:
- 2002-01-22 to 2002-02-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 07-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 07-1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1r,1's,4r,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-carboxylic acid
- EC Number:
- 613-782-9
- Cas Number:
- 65355-32-0
- Molecular formula:
- C16 H28 O2
- IUPAC Name:
- (1r,1's,4r,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 12 weeks (males) and 10-11 weeks (females)
- Weight at study initiation: 2.16 - 2.4 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood, and haysticks for gnawing
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Days 1 to 7
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- Before application, the test material was moistened with 0.1 mL of purified water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg
VEHICLE
Name: purified water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 2 females and 1 male
- Details on study design:
- TEST SITE
Four days before treatment, one flank was clipped. The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 500 mg of the test item was placed on a surgical gauze patch, which was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
OBSERVATION TIME POINTS
1 hour after removal, after 24, 48, 72 hours, and then daily up to experimental day 7.
Viability/Mortality/Clinical signs: Daily from delivery of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
Necropsy: Not performed as animals were sacrificed at termination of observation.
SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system
(Erythema: 0= no erythema, 1= very slight erythema, 2= well defined erythema, 3= moderate to severe erythema, 4= severe erythema. Edema: 0= no edema, 1= very slight edema, 2= slight edema, 3= moderate edema, 4= severe erythema) listed in the EU Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217, approximately 1, 24, 48 and 72 hours, as well as 7 days after the removal of the dressing, gauze patch and test item.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin irritating potential could be detected.
- Other effects:
- - pH measurements: Prior to the application, the pH of the test item was determined at a concentration of 1% in water with a pH test strip (E. Merck, D-64271 Darmstadt / Germany). The pH was found to be 5.
- Other adverse local effects: Very slight erythema was observed at the test site of two animals 1 hour after treatment (table 1). The test item did not, however, elicit any signs of irritation at the application site of any animal at the 24-, 48-, 72-hour or 7-day readings. The mean values from 24 to 72 hours were, therefore, 0 for erythema and 0 for edema (table 2).
Any other information on results incl. tables
Table 1: Skin irritation scores – individual values
Animal Number | Sex | Evaluation Interval | Erythema | Edema |
55 | M | 1 hour | 1 | 0 |
56 | F | 1 | 0 | |
57 | F | 0 | 0 | |
55 | M | 24 hours | 0 | 0 |
56 | F | 0 | 0 | |
57 | F | 0 | 0 | |
55 | M | 48 hours | 0 | 0 |
56 | F | 0 | 0 | |
57 | F | 0 | 0 | |
55 | M | 72 hours | 0 | 0 |
56 | F | 0 | 0 | |
57 | F | 0 | 0 | |
55 | M | 7 days | 0 | 0 |
56 | F | 0 | 0 | |
57 | F | 0 | 0 |
M= Male
F=Female
Table 2: Skin irritation scores – individual mean values after 24, 48 and 72 hours
Animal Number | Sex | Erythema | n | Edema | n |
55 | M | 0 | 3 | 0 | 3 |
56 | F | 0 | 3 | 0 | 3 |
57 | F | 0 | 3 | 0 | 3 |
n= number of available data points
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not induce significant or irreversible damage to the rabbit skin and is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48, 72 as well as 7 days after removal of the dressing. The application of the test item caused very slight erythema at the test site of two animals 1 hour after treatment. The test item did not, however, elicit any signs of irritation at the application site of any animal at the 24-, 48-, 72- hour or 7-day readings. The mean values from 24 to 72 hours were, therefore, 0 for erythema and 0 for edema. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Thus, the test item did not induce significant or irreversible damage to the rabbit skin. Based upon the referred classification criteria (EU Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217), the test item is considered to be "not irritating" to rabbit skin.
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