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Diss Factsheets
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EC number: 908-114-0 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The in vivo test was performed before the REACH regulation came into force, requesting in vitro studies. This information is used for read-across to Citronellyl Acetate Multi
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across information.
- Justification for type of information:
- The read-across justification is presented in the Endpoint summary Irritation. The accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Interpretation of results:
- other: Skin irritant Cat. 2
- Remarks:
- according to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- The mean erythema score (24 -72 hours) per animal was 3, 2.3 and 2.3 (highest score was 3, any erythema signs resolved on day 15), the mean edema scores were 1, 0.7 and 0.7 (any edema signs resolved at 72 hours). Scaling was observed in all animals 8 days after removal and scaling was still noted for one rabbit 15 days after removal. Based on these results from read-across, Citronellyl Acetate Multi is found to have skin irritant properties and is classified Category 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Citronellyl acetate
- EC Number:
- 205-775-0
- EC Name:
- Citronellyl acetate
- Cas Number:
- 150-84-5
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 3,7-dimethyloct-6-en-1-yl acetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. Thomae GmbH, Biberach
- Age at study initiation: young adult
- Animal identification: ear tattoo
- Weight at study initiation: female: 3.76 kg; male: 3.41 and 3.48 kg
- Housing: single housing, stainless stell wire mesh cages with grating, floor area: 3000 cm2
- Bedding: no bedding in the cages; sawdust in the waste trays
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Tap Water (about 250 ml/animal/day)
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml on intact untreated skin
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 15 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Preparation: at least 24 h before the test, the fur was removed by clipping the dorsal of the trunk of the animal; only animals with healthy/intact skin were used
- Area of exposure: upper third of back or flanks
- Application: 2.5 x 2.5 cm test patch moistened with 0.5 ml of the test substance
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adheasive Fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (BASF SE) and Lutrol in water (1:1)
- Time after start of exposure: 4 h
READING
- 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after patch removal
OBSERVATIONS
- Check for general observations and dead or moribund animals: twice daily (Mo - Fr), once daily (Sa/Su)
SCORING SYSTEM
- According to OECD guideline 404 (adopted july 17, 1992) and EEC L 383A, B.4 (december 29, 1992)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
Any other information on results incl. tables
For calculation of the means only the 24, 48 and 72 hours readings were taken into consideration.
Irritant response data:
Readings | Animal | Exposure period: 4 h | ||
Erythema | Edema | Additional findings | ||
1h | 1 | 2 | 1 | |
2 | 2 | 1 | ||
3 | 2 | 1 | ||
24 h | 1 | 3 | 2 | |
2 | 3 | 1 | ||
3 | 3 | 1 | ||
48 h | 1 | 3 | 1 | |
2 | 2 | 1 | ||
3 | 2 | 1 | ||
72 h | 1 | 3 | 0 | |
2 | 2 | 0 | ||
3 | 2 | 0 | ||
8 d | 1 | 1 | 0 | scaling |
2 | 0 | 0 | scaling | |
3 | 0 | 0 | scaling | |
15 d | 1 | 0 | 0 | scaling |
2 | 0 | 0 | ||
3 | 0 | 0 | ||
Mean 24 - 72 h | 1 | 3 | 1 | |
2 | 2.3 | 0.7 | ||
3 | 2.3 | 0.7 | ||
Mean | 2.5 | 0.8 |
Animal 1: female; animal 2: male; animal 3: male
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant Cat. 2
- Remarks:
- according to EU CLP (EC No. 1272/2008, and its amendments).
- Conclusions:
- The mean erythema score (24 -72 hours) per animal was 3, 2.3 and 2.3 (highest score was 3, any erythema signs resolved on day 15), the mean edema scores were 1, 0.7 and 0.7 (any edema signs resolved at 72 hours). Scaling was observed in all animals 8 days after removal and scaling was still noted for one rabbit 15 days after removal. Based on these results, Citronellyl Acetate (‘mono’) is found to have skin irritant properties and is classified Category 2.
- Executive summary:
An in vivo skin irritation test was performed with Citronellyl Acetate (‘mono’) according to OECD 404 and following GLP principles. Three rabbits were exposed semi-occlusively to 0.5 mL of the test substance (purity 98.8%) during 4 hours. After exposure, the sites were washed with Lutrol and Lutrol in water (1:1), skins were examined at 1 hour, 24, 48, 72 hours, 8 and 15 days after patch removal. The mean erythema score (24 -72 hours) per animal was 3, 2.3 and 2.3 (highest score was 3, any erythema signs resolved on day 15), the mean edema scores were 1, 0.7 and 0.7 (any edema signs resolved at 72 hours). Scaling was observed in all animals 8 days after removal and scaling was still noted for one rabbit 15 days after removal. Based on these results, Citronellyl Acetate (‘mono’) is found to have skin irritant properties and is classified Category 2: Irritant to the skin.
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