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EC number: 402-470-6 | CAS number: 87172-89-2 CINEOLE ALCOHOL
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial specific surface area
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- Endpoint summary
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- Environmental data
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- 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
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- Repeated dose toxicity
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- Additional toxicological data
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Endpoint summary
Administrative data
Description of key information
In a dermal skin sensitisation study according the Buehler method, the test substance did not cause dermal contact sensitisation in albino guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-02-18 to 1986-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A Buhler test with the test substance is available. The Buhler test has been shown to be sensitive enough to detect moderate to strong sensitisers and is thus considered suitable to address this endpoint.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA.
- Weight at study initiation: Test group: 413 +/-18; Naive control: 409 +/- 16; Positive control: 402 +/-12
- Housing: The animals were individually housed in wire-mesh cages.
- Diet: NIH Animal Feed A, Zeigler Brothers, Inc., Gardners, PA; ad libitum
- Water: Tap water; ad libitum
- Acclimation period: The animals were acclimated to the laboratory environment for at least 5 days
- Indication of any skin lesions: None
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12 - No. of animals per dose:
- Test group: 10 animals
Positive control: 6 animals
Naive control: 3 animals - Details on study design:
- RANGE FINDING TESTS:
A test item sample was prepared at concentrations of 25, 50 and 75% w/v in mineral oil immediately prior to application and dispensed for dose administration. The test article was also dispensed neat (as received from the Sponsor). Four female guinea gips were exposed once to the test article. No dermal irritation was observed following application of the tested concentrations. Based on the range finding study the test item was dispensed as received from the Sponsor for both the induction and challenge application.
MAIN STUDY
A. INDUCTION EXPOSURE (Day 1, 8, 15)
- No. of exposures: 3
- Exposure period: 6 h; Patches were secured in place after dose administration with an overwrap of Micropore® tape, plastic wrap and a stockinette sleeve. Following the exposure period, the patches were removed and any remaining material was gently wiped off with a clean gauze.
- Test groups: 10 animals (see table 1 for details).
- Control group:
Positve control: 6 female animals were exposed to DNCB (see table 1 for details).
Naive control: 3 additional animals serve as naive controls at the challenge (see table 1 for details).
- Site: Clipped back of the animals
- Frequency of applications: Once a week
- Concentrations: 0.5 g of the test item
B. CHALLENGE EXPOSURE (Day 29)
- No. of exposures: Single application
- Day of challenge: 29
- Exposure period: 6 h; Patches were secured in place after dose administration with an overwrap of Micropore® tape, plastic wrap and a stockinette sleeve. Following the exposure period, the patches were removed and any remaining material was gently wiped off with a clean gauze.
- Test groups: 10 animals (see table 1 for details).
- Control group:
Positve control: 6 female animals were exposed to DNCB (see table 1 for details).
Naive control: 3 additional animals serve as naive controls at the challenge (see table 1 for details).
- Site: Dorsal virgin skin sites
- Concentrations: 0.5 mL
OTHER:
Daily observations and dermal response evaluation:
All animals were observed daily for signs of toxicity and overt behavioral changes. Mortality checks were conducted twice daily, at least five hours apart. The application sites were examined for erythema and edema at 24 and 48 hours post-induction and challenge applications. Erythema and edema were scored according to the Draize method. - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g of the test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Edema and Erythema Score; For details see table 1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g of the test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Edema and Erythema Score; For details see table 1
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this Buehler test, the test substance did not cause dermal contact sensitisation in female albino guinea pigs.
Reference
Daily observation and body weight:
One animal exhibited soft stools during the study. All other animals appeared normal throughout the study period.
All animals gained weight during the study.
Induction Application:
Very slight (Draize score = 1) erythema was noted for one test article-treated animal following induction application two.
DNCB-treatment caused dermal irritation which was characterized by erythema. Individual erythema scores within this treatment group increased from none (0) to well-defined (2) after three applications. Slight (1) edema was observed in two DNCB-treated animals following induction application 3.
Challenge:
No irritation was noted in the test or naive animals following the challenge application. This response was significantly greater (p<=0.05) than the response obtained after the first induction application. Slight (1) edema was also observed following the challenge application of DNCB in one of the six animals.
Table 1: Summary of Dermal Response - Edema
Group |
Application |
Mean Edema Score |
|
24 h |
48 h |
||
Test |
Induction 1 |
0 |
0 |
Induction 2 |
0 |
0 |
|
Induction 3 |
0 |
0 |
|
Challenge |
0 |
0 |
|
Naive Control |
Challenge |
0 (3) |
0 (3) |
Positive Control |
|
|
|
DNCB (0.1% in 70% ethanol) |
Induction 1 |
0 (6) |
0 (6) |
DNCB (1.0% in 70% ethanol) |
Induction 1 |
0 (6) |
0 (6) |
Induction 2 |
0 (6) |
0 (6) |
|
Induction 3 |
0.3±0.5 (6) |
0.2±0.4 (6) |
|
DNCB (0.1% in 70% ethanol) |
Challenge |
0 (6) |
0.2±0.4 (6) |
70% ethanol |
Challenge |
0 (6) |
0 (6) |
Values are group mean±S.D. of scores read at 24 and 48 hours post-administration for 10 animals except where indicated in ()
Table 2: Summary of Dermal Response - Erythema
Group |
Application |
Mean Erythema Score |
|
24 h |
48 h |
||
Test |
Induction 1 |
0 |
0 |
Induction 2 |
0 |
0.1 ±0.3 |
|
Induction 3 |
0 |
0 |
|
Challenge |
0 |
0 |
|
Naive Control |
Challenge |
0 (3) |
0 (3) |
Positive Control |
|
|
|
DNCB (0.1% in 70% ethanol) |
Induction 1 |
0 (6) |
0 (6) |
DNCB (1.0% in 70% ethanol) |
Induction 1 |
1.2±0.4 (6) |
1.2±0.4 (6) |
Induction 2 |
1.0 ± 0 (6) |
1.0±0 (6) |
|
Induction 3 |
1.8±0.4 (6) |
1.8±0.4 (6) |
|
DNCB (0.1% in 70% ethanol) |
Challenge |
1.7 a±0.5 (6) |
1.5 a±0.5 (6) |
70% ethanol |
Challenge |
0 (6) |
0 (6) |
Values are group mean±S.D. of scores read at 24 and 48 hours post-administration for 10 animals except where indicated in ()
a Significantly different from induction application 1 (p≤0.05)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation:
A dermal skin sensitisation study with the test substance in guinea pigs according to the Buehler method was performed. Once a week for a total of three induction applications, ten female, albino, guinea pigs were exposed topically for six hours to 0.5 g of the test substance. After a two-week rest period, the induction test animals and three naive animals were challenged with 0.5 g of the test item. Another six animals served as the positive control group and were exposed to DNCB during induction and challenge applications. The application sites were examined and evaluated for erythema and edema. No significant irritation was observed in the test or naive animals. Thus, under the conditions of this study, the test substance did not cause dermal contact sensitisation in albino guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin sensitisation, the test item is not classified
according to Regulation (EC) No 1272/2008 (CLP), as amended for the
tenth time in Regulation (EU) No 2017/776.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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