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EC number: 449-360-4 | CAS number: 647828-16-8
- 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:
- 03 June 2003 to 17 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 449-360-4
- EC Name:
- -
- Cas Number:
- 647828-16-8
- Molecular formula:
- C18H32O
- IUPAC Name:
- decahydro-2,2,6,6,7,8,8-heptamethyl-2H-Indeno[4,5-b] furan
- 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: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Individually housed in suspended metal cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): At least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE:
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cotton gauze patch secured with a strip of surgical adhesive tape. Animal was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE:
- Washing: yes
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 Dyas
- Remarks on result:
- other: Reaction extends 3 cm beyond treatment site, light brown discolouration of the epidermis, loss of skin elasticity, and slight desquamation noted
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 Days
- Irritant / corrosive response data:
- The individual scores for erythemaleschar and oedema, are given in the table 1 at any other information on results.
Well-defined erythema was noted at all treated skin sites 1 hour after patch removal and at the 24, 48 and 72-hour observations. The reaction extended 3 cm beyond the treatment sites at the 24, 48 and 72-hour observations.
Slight oedema was noted at all treated skin sites one hour after patch removal and at the 24, 48 and 72-hour observations.
Light brown discolouration of the epidermis was noted at all treated skin sites at the 48 and 72-hour observations with an isolated incident of loss of skin elasticity at the 72-hour observation.
Severe desquamation was noted at all treated skin sites at the 7 -day observation.
All treated skin sites appeared normal at the 14-day observation.
Any other information on results incl. tables
Table 1. Individual Skin Reactions.
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
#1 Male |
#2 Male |
#3 Female |
|||
Erythema Formation |
1 hour |
2 |
2 |
2 |
(6) |
24 hours |
2R |
2R |
2R |
6 |
|
48 hours |
2RBr |
2RBr |
2RBr |
(6) |
|
72 hours |
2RBrLe |
2RBr |
2RBr |
6 |
|
7 days |
0D |
0D |
0D |
(0) |
|
14 days |
0 |
0 |
0 |
(0) |
|
Oedema Formation |
1 hour |
2 |
2 |
2 |
(6) |
24 hours |
2 |
2 |
2 |
6 |
|
48 hours |
2 |
2 |
2 |
(6) |
|
72 hours |
2 |
2 |
2 |
6 |
|
7 days |
0 |
0 |
0 |
0 |
|
14 days |
0 |
0 |
0 |
(0) |
|
Sum of 24 and 72-hour Readings (S): 24 |
|||||
Primary Irritation Index (S/6): 24/6 = 4.0 |
( ) = Total values not used for calculation of primary irritation index
R = Reaction extends 3 cm beyond treatment site
Br = Light brown discolouration of the epidermis
Le = Loss of skin elasticity
D = Slight desquamation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a skin irritant according to EU CLP (EC 1272/2008 and its amendments).
- Conclusions:
- The test substance was considered to be non-irritanting to skin based on OECD TG 404.
- Executive summary:
An in vivo skin irritation test was performed in accordance with OECD TG 404 and under GLP-conditions, to assess the irritancy potential of the test substance to the skin of the New Zealand White rabbit. A single 4-hour, semi-occluded application of the test substance to the intact skin of 3 rabbits produced well-defined erythema and slight oedema. These reactions scored maximally score 2 (Draize) and extended beyond all treated skin sites at the 24, 48 and 72-hour observations but was reversible within 14 days. Light brown discolouration, loss of skin elasticity and severe desquamation were also noted. No corrosive effects were observed. The test substance is considered not a skin irritant.
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