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EC number: 229-861-2 | CAS number: 6790-58-5
- 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:
- From 1992-08-24 to 1992-09-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to the original OECD Guideline 404 (1981).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (Adopted 12th May 1981)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- EC Number:
- 229-861-2
- EC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- Cas Number:
- 6790-58-5
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aR,5aS,9aS,9bR)-3a,6,6,9a-tetramethyl-dodecahydronaphtho[2,1-b]furan
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): 8α,-11-Oxido-13,14,15,16-tetranorlabdan / Ambroxan
- Physical state: white solid
- Stability under test conditions: stable for at least 2 years
- Storage condition of test material: cool and dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae GmbH, Biberach-D
- Age at study initiation: approximately 19 months
- Weight at study initiation: approximately 2460 g
- Housing: individual accommodation
- Diet (e.g. ad libitum): Ssniff rabbit diet K4, Ssniff GmbH, Soest-D (Batch 550792/01) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20-25°C
- Humidity (%): approximately 45-70%
- Air changes (per hr): at least eight per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: August 24, 1992 To: September 07, 1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- moistened
- Controls:
- other: untreated skin areas serve as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours and 7 days after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: right flank
- % coverage: ca. 6 cm²
- Type of wrap if used: adhesive air- and vapour permeable gauze-patch fixed by a hypo-allergenic adhesive gauze-bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, but no detail
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale, as described in OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Scratching was observed at 24-48-72 hours
- Irritant / corrosive response data:
- Slight to weak erythema and slight oedema of the first, slight erythema of the second, and no reaction of the third experimental animals were observed during the first 72 hours after exposure. One week later the first and second experimental animals were without irritation effects.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
1 / 1 / 0 |
1 / 0 / 0sc |
24 h |
2 / 1 / 0 |
1 / 0 / 0sc |
48 h |
1 / 1 / 0 |
0 / 0 / 0sc |
72 h |
1 / 1 / 0 |
0 / 0 / 0sc |
Average 24h, 48h, 72h |
1.3 / 1.0 / 0.0 |
0.3 / 0.0 / 0.0 |
Reversibility*) |
c. |
c. |
Average time for reversion |
7 days |
48 hours |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
sc = scratch
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material induces a slight to weak irritation being reversible within 7 days. Therefore the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 g of undiluted test material was moistened and applied on the shaved skin of the dorsal flank area of 3 Kleinrussen, Chbb:HM rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 hours and 7 days after the removal of the patch.
Slight to weak erythema and slight oedema of the first, slight erythema of the second, and no reaction of the third experimental animal were observed during the first 72 hours after exposure. One week later the first and the second experimental animal were without irritation effects.
The individual scores for each animal within 3 scoring times (24, 48 and 72 hours) were 1.33 / 1.00 / 0.00 for erythema and 0.33 / 0.00 / 0.00 for oedema.
Therefore the test material is not classified as irritant to the skin according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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