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EC number: 294-470-6 | CAS number: 91722-69-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula hybrida, Labiatae.
- 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:
- 23 October to 08 November 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 404 without any deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 16 December 2005
Test material
- Reference substance name:
- Lavender, Lavandula hybrida, ext.
- EC Number:
- 294-470-6
- EC Name:
- Lavender, Lavandula hybrida, ext.
- Cas Number:
- 91722-69-9
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- Essential oil of Lavandula x intermedia Emeric ex Loisel. (Lamiaceae) obtained from flowering tops by steam distillation
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ONIPPAM / 081007
- Physical state: Green to pale yellow liquid
- Date of receipt: 15 October 2007
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at 4 °C, protected from light and under nitrogen gas
- Stability under test conditions: Test item was considered to be stable during the study period
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France.
- Age at study initiation: 2-4 months
- Weight at study initiation: Mean body weight: 3.0 ± 0.3 kg
- Housing: Animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
- Diet: 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water (filtered by a FG Millipore membrane (0.22 µm)), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h dark/ 12 h light
IN-LIFE DATES: 23 October to 08 November 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted
- pH of the test item was not measurable (non-aqueous test item)
CONTROL
- Untreated skin served as control - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h after removal of the dressing. Since there was a persistent irritation reaction at 72 h, the observation period was extended up to their complete reversibility (Day 15).
- Number of animals:
- 3 males
- Details on study design:
- PRETREATMENT
Preparation and selection of the animals: The day before treatment, both flanks of each animal were clipped using electric clippers and just before treatment, the skin of each animal was examined in order to check the absence of any signs of skin irritation. Clipping was repeated thereafter on days 4 and 6 for the animal No. 555.
APPLICATION OF THE TEST ITEM
The test item was first evaluated on a single animal (No. 555). The durations of exposure were 3 minutes, 1 hour and 4 hours. Since the test item was not severely irritant nor corrosive on this first animal, it was then applied simultaneously for 4 hours to two other animals (Nos. 560 and 561).
TEST SITE
- Area of exposure: Test substance was applied to an area of approximately 6 cm2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals.
- Type of wrap if used: Test substance was placed on the gauze pad and held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the dressing, any residual test item was wiped off by means of a dry cotton pad.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48 and 72 h and Day 5 to 15
SCORING SYSTEM:
Draize scale, as described in OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- After a 3-minute exposure (one animal)
- A very slight erythema (grade 1) was noted from day 1 until day 6.
- A dryness of the skin was observed from day 4 until day 8.
After a 1-hour exposure (one animal)
- A very slight erythema (grade 1) was noted from day 1 until day 7.
- A dryness of the skin was observed from day 4 until day 8.
After a 4-hour exposure (three animals)
- A very slight or well-defined erythema (grade 1 or 2) was noted in all animals from day 1 until day 6 (1/3 animal) or 7 (2/3 animals).
- A dryness of the skin was recorded in all animals from day 4 until day 8 (1/3 animals) or 15 (end of the observation period; 2/3 animals).
- Mean scores over 24, 48 and 72 hours for each animal were 1.0, 1.0 and 1.3 for erythema and 0.0, 0.0 and 0.0 for edema. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: 4-hour exposure - Individual cutaneous examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Score at time point |
Erythema (Animal No. 1 / 2 / 3) Max. score 4 |
Oedema (Animal No. 1 / 2 / 3) Max. score 4 |
Other (Animal No. 1 / 2 / 3) |
1 h |
2/2/2 |
0/0/0 |
*/*/* |
24 h |
1/1/2 |
0/0/0 |
*/*/* |
48 h |
1/1/1 |
0/0/0 |
*/*/* |
72 h |
1/1/1 |
0/0/0 |
S/S/S |
Day 5 |
1/1/1 |
0/0/0 |
S/S/S |
Day 6 |
1/1/1 |
0/0/0 |
S/S/S |
Day 7 |
1/1/0 |
0/0/0 |
S/S/S |
Day 8 |
0/0/0 |
0/0/0 |
S/S/S |
Day 9 |
0/0/0 |
0/0/0 |
*/S/S |
Day 10 |
-/0/0 |
-/0/0 |
-/S/S |
Day 11 |
-/0/0 |
-/0/0 |
-/S/S |
Day 12 |
-/0/0 |
-/0/0 |
-/S/S |
Day 13 |
-/0/0 |
-/0/0 |
-/S/S |
Day 14 |
-/0/0 |
-/0/0 |
-/S/S |
Day 15 |
-/0/0 |
-/0/0 |
-/S/S |
Average 24, 48 and 72 h |
1.0/1.0/1.3 |
0/0/0 |
- |
Reversibility |
Completely reversible |
- |
- |
Average time for reversion |
8 days |
- |
- |
Animal No. 1 / 2 / 3 = Animal No. 555, 560 and 561, respectively
* = none
S = dryness of the skin
- = cutaneous examination not performedApplicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified as irritant according to Regulation (EC) No 1272/2008 (CLP) and to GHS.
- Executive summary:
A dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP. The test substance was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since the test substance was not severely irritant nor corrosive on this first animal, it was then applied simultaneously for 4 hours to two other animals.
A single dose of 0.5 mL of the undiluted test substance was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the observation period. The mean values of the scores for erythema and edema were calculated for each animal.
After a 3-minute exposure (one animal): A very slight erythema was noted from day 1 until day 6. A dryness of the skin was observed from day 4 until day 8.
After a 1-hour exposure (one animal): A very slight erythema was noted from day 1 until day 7. A dryness of the skin was observed from day 4 until day 8.
After a 4-hour exposure (three animals): A very slight or well-defined erythema was noted in all animals from day 1 until day 6 (1/3 animal) or 7 (2/3 animals). A dryness of the skin was recorded in all animals from day 4 until day 8 (1/3 animals) or 15 (end of the observation period; 2/3 animals).
Mean scores over 24, 48 and 72 hours for each animal were 1.0, 1.0 and 1.3 for erythema and 0.0, 0.0 and 0.0 for edema.
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