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EC number: 279-815-0 | CAS number: 81782-77-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8th August 2000 to 5th September 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methyl-3-decen-5-ol
- EC Number:
- 279-815-0
- EC Name:
- 4-methyl-3-decen-5-ol
- Cas Number:
- 81782-77-6
- Molecular formula:
- C11H22O
- IUPAC Name:
- 4-methyldec-3-en-5-ol
- 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: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France- Age at study initiation: 14 weeks (males) and 15 weeks (females)- Weight at study initiation: 2.7 - 2.9 kg- Housing: Individually in stainless steel cages- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum, batch no. 30/00, provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Haysticks, QS n. 137/00, provided by Eberle Nafag AG, CH-9200 Gossau- Water (e.g. ad libitum): Tap water from Füllinsdorf, ad libitum- Acclimation period: 6 days under laboratory conditionsENVIRONMENTAL CONDITIONS- Temperature (°C): 21 - 23.5 °C- Humidity (%): 44 - 79 %- Air changes (per hr): 10 - 15 charges per hour- Photoperiod (hrs dark / hrs light): 12 hrs light and 12 hours dark.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): Single dose of 0.5 mL
- Duration of treatment / exposure:
- Duration of exposure: 4 hours
- Observation period:
- A total of 21 days at the following time points: 1, 24, 48 and 72 hours and 7, 10, 14, 17 and 21 days.
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE- Area of exposure: 6 cm² (2.5 x 2.5 cm)- Type of wrap if used: Approximately 6 cm² of surgical gauze, covered with a semi-occlusive dressing, which was wrapped around the abdomen and anchored with tape.REMOVAL OF TEST SUBSTANCE- Washing (if done): Yes with lukewarm tap water.- Time after start of exposure: 4 hours post application.OBSERVATIONS:Mortality/Viability - Daily until termination of the test.Clinical Signs - Daily until termination of the test.Body weight - At the start of acclimatisation, day of application and at termination of the test.No necropsy was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Irritation scores were calculated as a mean of the three animals over the three time point 24, 48 and 72 hours for both erythema and oedema.Slight scaling was observed in all animals at day 7 all were recoved by day 21
- Other effects:
- Mortality - none occurred.Clinical Signs - no systemic signs of toxicity.Body Weight - all rabbits were considered to be within the normal range of variability.Colouration - no staining to the skin was observed.Corrosion - no irreversible alterations of the treated skin were observed nor were corrosion effects evident on the skin.
Any other information on results incl. tables
Table 2. Individual Skin Irritation Scores.
Animal |
Sex |
Evaluation Interval |
Erythema |
Oedema |
Cumulative |
Scaling |
|
Score |
Mean |
||||||
73 |
M |
1 hour |
2 |
2 |
4 |
3.33 |
0 |
74 |
F |
2 |
1 |
3 |
0 |
||
75 |
F |
2 |
1 |
3 |
0 |
||
73 |
M |
24 hours |
2 |
1 |
3 |
3.00 |
0 |
74 |
F |
2 |
1 |
3 |
0 |
||
75 |
F |
2 |
1 |
3 |
0 |
||
73 |
M |
48 hours |
1 |
1 |
2 |
2.00 |
0 |
74 |
F |
2 |
1 |
3 |
0 |
||
75 |
F |
1 |
0 |
1 |
1 |
||
73 |
M |
72 hours |
1 |
0 |
1 |
0.67 |
0 |
74 |
F |
1 |
0 |
1 |
0 |
||
75 |
F |
0 |
0 |
0 |
1 |
||
73 |
M |
7 days |
0 |
0 |
0 |
0.00 |
2 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
1 |
||
73 |
M |
10 days |
0 |
0 |
0 |
0.00 |
1 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
0 |
||
73 |
M |
14 days |
0 |
0 |
0 |
0.00 |
0 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
0 |
||
73 |
M |
17 days |
0 |
0 |
0 |
0.00 |
0 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
0 |
||
73 |
M |
21 days |
0 |
0 |
0 |
0.00 |
0 |
74 |
F |
0 |
0 |
0 |
0 |
||
75 |
F |
0 |
0 |
0 |
0 |
Table 3. Mean Skin Irritation Scores After 48 and 72 Hours.
Animal |
Sex |
Erythema |
Oedema |
73 |
M |
1.33 |
0.67 |
74 |
F |
1.67 |
0.67 |
75 |
F |
1.00 |
0.33 |
Mean |
|
1.33 |
0.56 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test material was determined to be not irritating. Slight erythema (1.33) and oedema (0.56) were observed, however the effects were not severe enough to trigger a classification and all effects were fully reversible within 21 days.
- Executive summary:
In a GLP compliant skin irritation study, performed to standardised guidelines OECD 404 and EU method B.4 the irritation potential of the test material was determined in a 4 hour semi-occlusive test. Three rabbits were exposed to 0.5 mL of the unchanged test material for a duration of 4 hours and observed for 21 days. The mean scores from observation at 24, 48 and 72 hours were used to determine a classification. Slight erythema 1.33 and oedema 0.56 were observed, however, the effects were not severe and were fully reverse within 21 days. Under the conditions of the test, the test material was determined to be not irritating, and no classification is required under Regulation 1272/2008.
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