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Diss Factsheets
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EC number: 201-289-8 | CAS number: 80-54-6
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October 1997 - October 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well described publication which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Further important sensitizers in patients sensitive to fragrances: I. Reactivity to 14 frequently used chemicals
- Author:
- Frosch P.J., Johansen J.D., Menné T., Pirker C., Rasogi S.C., Andersen K.E., Bruze M., Goosens A., Lepoittevin J.P. White I.R
- Year:
- 2 002
- Bibliographic source:
- Contact Dermatitis 2002, 47, 78-85
- Reference Type:
- secondary source
- Title:
- Further important sensitizers in patients sensitive to fragrances: I. Reactivity to 14 frequently used chemicals
- Author:
- Frosch P.J., Johansen J.D., Menné T., Pirker C., Rasogi S.C., Andersen K.E., Bruze M., Goosens A., Lepoittevin J.P. White I.R
- Year:
- 2 002
- Bibliographic source:
- Contact Dermatitis 2002, 47, 78-85 [as cited in RIFM and FEMA Fragrance and Flavour Database (online), 188, Location 41242, updated 28-Sep-07]
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human Patch Test with individuals who had a history of adverse reaction to fragrances
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- EC Number:
- 201-289-8
- EC Name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- Cas Number:
- 80-54-6
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-(4-tert-butylphenyl)-2-methylpropanal
- Details on test material:
- - Name as cited in document: Lilial (2-methyl-3(4-tert-butylphenyl)propanal
- Analytical purity: => 95
- Source: Dragoco (Holzminden, Germany)
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 1855
- Clinical history:
- Each patient was placed in 1 of 4 categories (certain, probable, questionable and none) according to a history of adverse reactions to fragrances as described in Frosch et al. 1999. This history was taken before the patch testing procedure.
Frosch P J, Johansen J D, Menné T et al. Lyral is an important sensitizer in patients sensitive to fragrances. Br J Dermatol 1999: 141: 1076-1083 - Controls:
- Fragrance mix (8%) supplied by Hermal, Reinbek, Germany (Larsen in 1977, Arch Dermatol 1977 : 113 : 623-626)
- Route of administration:
- dermal
- Details on study design:
- The tests were performed in 6 dermatological centres across europe (Dortmund, Copenhagen, Malmo, Odense, London and Leuven). A total of 14 fragrance compounds (termed: series I) were tested in the study.
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: no data
- Site of application: skin of the back
- Description of patch: Finn Chambers on Scanpor and van der Bend chambers (only in Leuven)
- Vehicle: petrolatum
- Concentrations: 10% (based on literature reports and pilot testing performed in 4 centres (Copenhagen, Dortmund, Malmoe, London)
- Volume applied: no data
- Duration of application: 2 days
- Testing/scoring schedule: reading were taken at most centers on day 2 and day 4. The reading on day 3 or day 4 was used for overall evaluation of positive test results
- Removal of test substance: no details given
EXAMINATIONS
- Grading/Scoring system: according to published guidelines (Wahlberg J E. Patch testing In: Rycroft R.J.G, Menné T., Lepoittevin J.P., eds . Textbook of Contact Dermatitis, 3rd edn . Heidelberg : Springer, 2001 : 435-468
- Statistical analysis: no data
Results and discussion
- Results of examinations:
- RESULT OF CASE REPORT: see table 1
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION: see table 2
- 3 cases of positive reaction to Lysmeral. In the 2 with a + + reaction, the fragrance mix (FM) was positive only in 1; this patient also had a certain fragrance history, while the other 2 patients had a questionable and no history, respectively.
Any other information on results incl. tables
Table 1: History of adverse reaction to fragrances of the patients involved in the study
Group |
History |
FM positive |
Series I and FM postive |
Only Series I positives |
Certain |
124/1855 (6.6%) |
51/124 (41.1%) |
15/124 (12.0%) |
9/124 (7.2%) |
Probable |
150/1855 (8.0%) |
29/150 (19.3%) |
7/150 (4.7%) |
6/150 (4.0%) |
Questionable |
170/1855 (9.2%) |
14/170 (8.2%) |
7/170 (4.1%) |
7/170 (3.5%) |
None |
1411/1855 (76.1%) |
77/1411 (5.4%) |
10/1411 (0.7%) |
19/1411 (1.3%) |
Table 2: Results obtained by testing 1855 consecutive patients. Listed are the numbers of observed reactions
Doubtful |
Positive |
||||||
n |
% |
+ |
++ |
+++ |
Total |
% |
|
FM (8%) |
116 |
6.3 |
110 |
80 |
20 |
210 |
11.3 |
Lysmeral (10%) |
12 |
0.6 |
1 |
2 |
0 |
3 |
0.2 |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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