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EC number: 289-995-2 | CAS number: 90063-37-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula angustifolia, 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
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study on rats, the Oral LD50 was calculated at 6.2 +/- 0.8 mL/kg for males and at 5.0 +/-0.9 mL/kg bw for females. (Rel. K2)
In an acute dermal toxicity study, the dermal LD50 of Lavender oil was higher than 5000 mg/kg bw in rats (Rel. K2).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - April 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: French Norm NF T 03-021 détermination de la toxicité aigüe chez le Rat, administration unique orale"
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA-CREDO (Domaine des Oncins, 69210 L'Arbresle France)
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Weight at study initiation: 150g
- Housing: group of 5 animals, in Makrolon polycarbonate Bayer Techniplast cage
- Diet ad libitum, exept 18 hours before administration of the test item
- Water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 15 volum per hour
- Photoperiod (hrs dark / hrs light): 12H dark/ 12 H light - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 3, 4,5,6, and 7 ml/kg body weight
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes
- Remarks:
- dosed with volume of 7ml/kg of filtered water
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation before administration of the test item, and then twice a day exept on saturday and sunday (once a day). Weighing at day : D-1, D1, D2, D3, D8 and D15.
- Necropsy of animails dying during the study, and macroscopic examination
- Necropsy of survivors performed: yes: macropsy of abdominals and thoracic organs
- Other examinations performed: clinical signs, body weight, food and water consumption - Statistics:
- Statistical interpretation of the weight evolution: study of the homogeneity of the body weights tested before the treatment by comparison of the variances of the animals group (test of Bartlett), then comparition of the means of the groups or the rows (ANVA 1 if the variances are homogeneous, test of Kruskal-Wallis if they are heterogeneous).
The study of the effect of the treatment is carried out by ANVA1 per day of measurement after tests of variances. In the case of a sinificative difference, the direction of the difference is sought by the Dunnett t test
The results are averaged, the average is accompanied by the estimated standard deviation of the mean.The DL 50 is evaluated by the Miller & Tanner method. - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5.4 - < 7 mL/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 4.1 - < 5.9 mL/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 5 mL/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 3 mL/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD100
- Effect level:
- > 7 mL/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- > 6 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Late mortality occurs approximately 20 hours after oral treatment and extends up to 32 hours. No animal died in group treated at 3 ml/kg.
No males died in groups treated at 4 and 5 ml/kg.
One female died in group treated at 4 ml/kg and one in the group treated at 5 ml/kg.
In group treated at 6 ml/kg 2 males died and all the females (see table 1 in any other information on results) - Clinical signs:
- other: The toxic symptomatology appears in 1 hour in male and female: abatement, abdominal contractions and / or piloerection. These symptoms disappear at the end of the day in the 3 ml / kg (male and female) treated groupand in animals treated at 4 and 5 ml / k
- Other findings:
- Other fidings In both sexes, food consumption is greatly reduced within 24 hours of single treatment, and for all treated groups. Dietary intakes were comparable to those of controls after days in the 4 and 5 mL / kg treated animals and after 3 days in the 6 and 7 mL / kg treated groups. Subsequently drinking is similar for all animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study 5 male rats and 5 female rats were given single oral doses of Lavander oil at 3 or 4 or 5 or 6 or 7 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.
There is no mortality for males dosed up to 5 mL/ kg bw. At 6 mL/ kg bw 2 males died, and 4 at 7 mL/kg bw.
At 4 and 5 mL/kg bw one female died, and at 6 and 7 mL/kg bw all female died.
The Oral LD50 was calculated at 6.2 +/- 0.8 mL/kg for male and at 5.0 +/-0.9 mL/kg bw for female.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Reference
Table 1: mortality :
Dose (ml/kg) |
Male dead |
Female dead |
0 |
0/5 |
0/5 |
3 |
0/5 |
0/5 |
4 |
0/5 |
1/5 (in 24 hours) |
5 |
0/5 |
1/5 (in 24 hours) |
6 |
2/5 (in 24 hours) |
5/5 (in 24 hours) |
7 |
3/5 (in 24 hours) 4/5 (in 32 hours) |
3/5 (in 24 hours) 5/5 (in 32 hours) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- Principles of method if other than guideline:
- Standard acute method (limit test): 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- None
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- None
- Duration of exposure:
- After single application of the test subsance, all animals were observed for 14 days.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 rabbits
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Examinations performed: Mortality, clinical signs and dermal reactions.
- Necropsy of survivors performed: No - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: indication of slight to moderate irritation
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs of toxicity occurred during the study.
- Gross pathology:
- Not applicable
- Other findings:
- - Dermal reactions: Slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the dermal LD50 of the test substance is >5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
- Executive summary:
In an acute dermal toxicity study (limit test), 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.
No deaths and no clinical signs of toxicity occurred during the observation period. Dermal reactions noted were slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.
Under the test conditions, the dermal LD50 of the test substance is >5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Additional information
In an acute oral toxicity study 5 male rats and 5 female rats were given single oral doses of Lavander oil at 3 or 4 or 5 or 6 or 7 mL/kg bw. Animals were observed for mortality and clinical signs for 14 days.
There is no mortality for males dosed up to 5 mL/ kg bw. At 6 mL/ kg bw 2 males died, and 4 at 7 mL/kg bw.
At 4 and 5 mL/kg bw one female died, and at 6 and 7 mL/kg bw all female died.
The Oral LD50 was calculated at 6.2 +/- 0.8 mL/kg for male and at 5.0 +/-0.9 mL/kg bw for female.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
In an acute dermal toxicity study (limit test), 10 rabbits were administered a single dermal dose of the test substance at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.
No deaths and no clinical signs of toxicity occurred during the observation period. Dermal reactions noted were slight redness (9/10 rabbits), slight edema (1/10 rabbit) and moderate edema (2/10 rabbits) at the site of application.
Under the test conditions, the dermal LD50 of the test substance is >5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
Justification for classification or non-classification
Self classification:
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the oral and dermal LD50 are higher than 5000 mg/kg bw.
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