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Diss Factsheets
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EC number: 203-376-6 | CAS number: 106-23-0
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: Review article
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Reevaluation of data from sensitisation assays with citral both in humans and test animals, compiled data are both from reliable published studies and from RIFM study reports which are not publically available; review acceptable for identifying a threshold for sensitisation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Citral: Identifying a threshold for induction of dermal sensitization
- Author:
- Lalko J, Api AM
- Year:
- 2 008
- Bibliographic source:
- Reg Toxicol Pharmacol 52: 62-73
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human repeated insult patch test (general principle): induction by nine 24-h occluded applications within 3 weeks, 2 week rest period, challenge by single 24-h patch
Human maximization test (general principle): induction by 5 alternate day 48-h occluded patches, 10 to 14-day rest period, challenge by 48-h patch - GLP compliance:
- not specified
Test material
- Reference substance name:
- Citral
- EC Number:
- 226-394-6
- EC Name:
- Citral
- Cas Number:
- 5392-40-5
- Molecular formula:
- C10H16O
- IUPAC Name:
- Reaction mass of (E)-3,7-dimethylocta-2,6-dienal and (Z)-3,7-dimethylocta-2,6-dienal
- Reference substance name:
- (Z)-3,7-dimethylocta-2,6-dienal
- EC Number:
- 203-379-2
- EC Name:
- (Z)-3,7-dimethylocta-2,6-dienal
Constituent 1
Constituent 2
Method
- Type of population:
- general
Results and discussion
- Results of examinations:
- NOEL of 1400 µg/cm2
Any other information on results incl. tables
Sensitisation data in humans
The review of Lalko and Api (2008) compiled data from 5 human repeat insult patch tests (HRIPT; unpublished RIFM studies) and 14 human maximization tests (HMT) which are exclusively cited from unpublished RIFM reports. Furthermore various clinical diagnostic patch tests with citral have been assessed.
Evaluation of human maximization test (HMT)data:
In all but one HMT, citral induced sensitisation at test concentrations ranging from 4 to 8% corresponding to 2759 to 5517 µg/cm2citral in petrolatum. Overall, a decrease in the incidences of positive responses have been observed by increased doses. In a single HMT conducted with 2% (1379 µg/cm2) citral in petrolatum on 24 male volunteers, sensitization reactions (2/24) were observed.
Evaluation of human repeated insult patch test (HRIPT) data:
Test concentrations in the different studies covered a range of 388 to 3876 µg/cm2;
No sensitising effects were observed up to 1400 µg/cm2; A sensitisation rate of 5/8 was observed at the highest test concentration of 3876 µg/cm2
Overview on diagnostic patch tests with citral*:
*The table is restricted to the literature reports of clinical diagnostic patch tests to citral in greater than 100 consecutive patients.
Concentration/Vehicle |
Results |
References |
5% in petrolatum |
4/155 cosmetic dermatitis patients |
Ishihara et al. (1981) |
5/159 eczema/dermatitis patients |
||
0/48 control subjects |
||
5% VNR |
8/310 cosmetic dermatitis patients |
Itoh et al. (1986, 1988), Nishimura et al.(1984) |
9/408 non-cosmetic patients |
||
1/122 control subjects |
||
2% VNR |
21/1825 patients |
Frosch et al. (2002) |
2% in petrolatum |
19/1825 patients |
DeGroot et al. (2000) |
2% VNR |
12/1701 patients |
Frosch et al. (2004, 2005) |
2% VNR |
28/658 patients |
Heydorn et al. (2002, 2003a,b) |
2% VNR |
1/240 cosmetic dermatitis patients |
Itoh et al. (1986, 1988), Nishimura et al.(1984) |
2/584 non-cosmetic patients |
||
0/105 control subjects |
||
1% VNR |
6/1701 patients |
Frosch et al. (2004, 2005) |
1% VNR |
4/228 patients |
Mitchell et al. (1982) |
1% in petrolatum |
8/192 patients |
Frosch et al. (1995) |
0.1% VNR |
1/192 (reaction was questionable) patients |
Frosch et al. (1995) |
Abbreviations: VNR = vehicle not reported.
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.
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