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EC number: 412-280-5 | CAS number: 2511-00-4 POIRENATE
- 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
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- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 november to 14 December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to the EEC Method B.6, Part B and it is GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Ethyl 2-cyclohexylpropionate
- EC Number:
- 412-280-5
- EC Name:
- Ethyl 2-cyclohexylpropionate
- Cas Number:
- 2511-00-4
- Molecular formula:
- C11H20O2
- IUPAC Name:
- ethyl 2-cyclohexylpropanoate
- Details on test material:
- - Physical state: clear liquid
- Storage condition of test material: 4ºC in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dutch
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D.Hall, Newchurch, Staffordshire, England
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 299-358g
- Housing: in group of 10 in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- coconut oil
- Concentration / amount:
- Table 4 and 5
Challengeopen allclose all
- Route:
- other: topical induction
- Vehicle:
- coconut oil
- Concentration / amount:
- Table 4 and 5
- No. of animals per dose:
- 30
- Details on study design:
- POSITIVE CONTROL
-Results in table 6
TREATMENT PROCEDURE
Preliminary study
- Results in table 4
Induction:
- Intradermal injection: 20% v/v in Alembicol D
- Topical application: As supplied
This was the maximum practical concentration and did not give rise to irritating effects
CHALLENGE
Topical applications: as supplied
From preliminary investigations the test substance, as supplied was the maximum practical concentration and did not give rise to irritating effects.
Main study: the procedure may be considered in two parts, induction and challenge.
INDUCTION
Injectables for the test animals were prepared as follows:
1. Freund's complete adjuvant* was diluted with an equal volume of water for irrigation (Ph.eur.)
2. The test substance, 20% v/v in Alembicol D.
3. The test substance, 20% v/v in a 50:50 mixture of Freund's complete adjuvant and Alembicol D.
Control animals: Table 1
CHALLENGE
The control and test animals were challenge topically two weeks after the topical induction applications using the test substance, as supplied and 50% v/v in Alembicol D. - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Health status:
No signs of ill health or toxic were recorded
Induction:
Dermal reactions seen following the induction applications are summarised in Table 1:
Intradermal injections:
Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals.
Irritation was seen in test animals at sites receiving the test substance, 20% v/v in Alembicol D. Very slight irritation was observed in control animals.
Topical applications:
Moderate erythema was observed in test animals following topical application with the test subtance, as supplied.
Similar signs of irritation were seen in the controls.
Challenge:
The numerical values given to the dermal reactions elicited by the challenge application are shown in Table 2.
The dermal response seen in test and control animals was similar.
Any other information on results incl. tables
Table 1 | ||||
Dermal reactions observed after each induction | ||||
Site | Intradermal injection | Topical applications | ||
Test animals | Control animals | Test animals | Control animals | |
1 | Necrosis | Necrosis | Moderate erythema | Moderate erythema |
2 | Irritation | Necrosis | ||
3 | Necrosis | Necrosis |
Table 2 | ||||||||
Dermal reactions observed after the challenge application with the test substance | ||||||||
Guinea-pig number | E=Erythema O=Oedema |
Score | Results Positive (+) Negative (-) Inconclusive (±) |
|||||
24 hours | 48 hours | 72 hours | ||||||
A | P | A | P | A | P | |||
4900 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4901 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4902 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4903 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4904 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4905 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4906 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4907 | E | 0 | 0 | 0 | 0 | 0* | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4908 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4909 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4910 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4911 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4912 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4913 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4914 | E | 0* | 0 | 0* | 0 | 0* | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4915 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4916 | E | 0* | 0 | 0* | 0 | 0* | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4917 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4918 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4919 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4920 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4921 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4922 | E | 0* | 0 | 0* | 0 | 0* | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4923 | E | 0 | 0 | 0 | 0 | 0* | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4924 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4925 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4926 | E | 0 | 0 | 0 | 0 | 0* | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4927 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4928 | E | 0 | 0 | 0 | 0 | 0* | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - | |
4929 | E | 0 | 0 | 0 | 0 | 0 | 0 | - |
O | 0 | 0 | 0 | 0 | 0 | 0 | - |
*: Dryness and sloughing of the epidermis | |||
a: Anterior site, exposed to the test substance, as supplied | |||
P: Posterior site, exposed to the test substance, 50% v/v in Alembicol D |
Table 3 | |||
Group | Guinea-pig number | At start of study 19.11.91 | at finish of study |
Control | 4900 | 475 | 632 |
4901 | 548 | 655 | |
4902 | 484 | 689 | |
4903 | 472 | 592 | |
4904 | 458 | 603 | |
4905 | 510 | 642 | |
4906 | 468 | 644 | |
4907 | 503 | 698 | |
4908 | 487 | 610 | |
4909 | 487 | 621 | |
Test | 4910 | 446 | 552 |
4911 | 424 | 553 | |
4912 | 443 | 570 | |
4913 | 435 | 562 | |
4914 | 401 | 534 | |
4915 | 451 | 627 | |
4916 | 456 | 604 | |
4917 | 480 | 649 | |
4918 | 453 | 597 | |
4919 | 423 | 585 | |
4920 | 442 | 574 | |
4921 | 454 | 603 | |
4922 | 502 | 609 | |
4923 | 429 | 571 | |
4924 | 469 | 626 | |
4925 | 454 | 614 | |
4926 | 453 | 594 | |
4927 | 464 | 666 | |
4928 | 458 | 586 | |
4929 | 474 | 594 |
Table 4 | ||||
Results of preliminary investigations with the test substance | ||||
Intradermal injections | ||||
Vehicle: Alembicol D | ||||
Guinea-pig number | Concentration % v/v | Score | ||
Hours | 24 | 72 | ||
471 | 30 | D | 10 | 10 |
E | SN | SN | ||
O | 2 | 2 | ||
20 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 1 | ||
454 | 10 | D | 10 | 10 |
E | 2 | 2 | ||
O | 2 | 2 | ||
7,5 | D | 10 | 10 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
5 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
2,5 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
1 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
0,5 | D | 6 | 6 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
Vehicle control | D | 3 | 3 | |
E | 1 | 1 | ||
O | 1 | 1 | ||
468 | 30 | D | 10 | 10 |
E | SN | N | ||
O | 2 | 2 | ||
20 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
456 | 10 | D | 10 | 10 |
E | 2 | 2 | ||
O | 2 | 2 | ||
7,5 | D | 10 | 10 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
5 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
2,5 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
1 | D | 8 | 8 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
0,5 | D | 6 | 6 | |
E | 2 | 2 | ||
O | 2 | 2 | ||
Vehicle control | D | 3 | 3 | |
E | 1 | 1 | ||
O | 1 | 1 | ||
D: Diameter (mm) | ||||
E: Erythema (0-4 numerical scores) | ||||
O:Oedema (0-4 numerical scores) | ||||
N: Necrosis | ||||
SN: Slight necrosis |
Table 5 | |||||||
Topical appliaction | |||||||
Vehicle: Alembicol D | |||||||
Guinea-pig number | Concentration % v/v | Score | |||||
0 Hours | 24 Hours | 48 Hours | |||||
E | O | E | O | E | O | ||
450 | As supplied | 0 | 0 | 0 | 0 | 0 | 0 |
75 | 0 | 0 | 0 | 0 | 0 | 0 | |
60 | 0 | 0 | 0 | 0 | 0 | 0 | |
50 | 0 | 0 | 0 | 0 | 0 | 0 | |
451 | As supplied | 0 | 0 | 0 | 0 | 0 | 0 |
75 | 0 | 0 | 0 | 0 | 0 | 0 | |
60 | 0 | 0 | 0 | 0 | 0 | 0 | |
50 | 0 | 0 | 0 | 0 | 0 | 0 | |
448 | As supplied | 0 | 0 | 0 | 0 | 0 | 0 |
75 | 0 | 0 | 0 | 0 | 0 | 0 | |
60 | 0 | 0 | 0 | 0 | 0 | 0 | |
50 | 0 | 0 | 0 | 0 | 0 | 0 | |
455 | As supplied | 0 | 0 | 0 | 0 | 0 | 0 |
75 | 0 | 0 | 0 | 0 | 0 | 0 | |
60 | 0 | 0 | 0 | 0 | 0 | 0 | |
50 | 0 | 0 | 0 | 0 | 0 | 0 | |
E: Erythem (0-4 numerical scores) | |||||||
O: Oedema (0-4 numerical scores) |
Table 6 | |||||||||||
Summary of positive control data Magnusson and Kligman test using formalin | |||||||||||
M&K R&D No. | Numerical of female animals | Dates of study | Dates of study of receipt of Formalin | Dose Levels % (aqueous dilutions) | Results | ||||||
Induction | Challenge | Positive | Inconclusive | Negative | |||||||
Test | Control | Start | Finish | Intradermal | Topical | ||||||
20 | 20 | 20 | 06.01.86 | 03.02.86 | 11.12.85 | 0,05 | 10 | 5 and 2,5 | 10/20 | 7/20 | 3/20 |
21 | 20 | 20 | 07.04.86 | 02.05.86 | 11.12.85 | 0,1 | 10 | 5 and 1 | 17/20 | 2/20 | 1/20 |
22 | 20 | 10 | 09.06.86 | 04.07.86 | 11.12.85 | 0,1 | 10 | 5 and 1 | 19/19* | 0/19* | 0/19* |
23 | 10 | 10 | 16.02.87 | 13.03.87 | 09.12.86 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
24 | 10 | 10 | 23.03.87 | 17.04.87 | 09.12.86 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
25 | 10 | 10 | 30.06.87 | 25.07.87 | 09.12.86 | 0,1 | 10 | 5 and 1 | 8/10 | 0/10 | 2/10 |
26 | 10 | 10 | 18.01.88 | 12.02.88 | 05.08.87 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
27 | 10 | 10 | 21.07.88 | 15.08.88 | 13.05.88 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
28 | 10 | 10 | 10.01.89 | 04.02.89 | 16.12.88 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
29 | 10 | 10 | 17.07.89 | 11.08.89 | 15.05.89 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
30 | I 10 | 10 | 31.10.89 | 25.11.89 | 15.05.89 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
31 | 10 | 10 | 16.01.90 | 10.02.90 | 29.11.89 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
32 | 10 | 10 | 23.07.90 | 24.08.90 | 04.07.90 | 0,05 | 5 | 3 and 1,5 5 and 3*** |
5/10 10/10 |
0/10 0/10 |
5/10 0/10 |
33 | 10 | 10 | 30.10.90 | 24.11.90 | 04.07.90 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
34 | 10 | 10 | 15.01.91 | 09.01.91 | 09.01.91 | 0,1 | 10 | 5 and 1 | 8/10 | 1/10 | 1/10 |
35 | 10 | 10 | 06.03.91 | 31.03.91 | 09.01.91 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
36 | 10 | 10 | 12.03.91 | 06.04.91 | 09.01.91 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
37 | 10 | 10 | 15.08.91 | 09.09.91 | 19.06.91 | 0,1 | 10 | 5 and 1 | 10/10 | 0/10 | 0/10 |
I Animals supplied by Interfauna, Huntingdon, Cambridgeshire, England
All other animals supplied by D.Hall, Newchurch, Staffordshire, England
(Fromain obtained from Savory and Moore, Huntingdon, Cambridgeshire, England or from 1991, supplied by Thornton and Ross, Hunddersfield, England)
* One animal excluded due to poor health status
** Second challenge
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this tes, performed in twenty albino guinea-pigs of the test substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity).
- Executive summary:
The study was performed to assess the skin sensitisation potential of the test substance in the guinea-pig. The method followed was that described in the EEC Methods for the determianation of toxicity, Directive 84/449/EEC Part B, Method B.6. Acute toxicity (skin sensitization).
Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:
- Intradermal injection: 20% v/v in Alembicol D.
- Topical application: as supplied.
- Challenge application: as supplied and 50% v/v in Alembicol D.
Twenty test and ten conrol guinea-pigs were used in this study.
The test substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity).
The test substance does not require labelling with the risk pharse R43 "May cause sensitization" by skin contact" in accordance with Council Directive 79/831/EEC Annex V1, Part II (D) as described in Commission Directive 91/325/EEC.
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