Registration Dossier
Registration Dossier
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EC number: 946-009-1 | CAS number: 91722-69-9
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral in mouse: LD50 > 5 mL/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel.2)
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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no data about purity and no certificate of analysis of the test substance; no data on strain/sex of animals dosed; environmental conditions not reported; 7 days observation period
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no data about purity and no certificate of analysis of the test substance; no data on strain/sex of animals dosed; environmental conditions not reported; 7 days observation period
- Principles of method if other than guideline:
- Not applicable
- 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:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Fasting period before study: 4 hours
- Diet fed after treatment: Commercial stock diet - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- None
- Doses:
- 5 mL/kg bw
- No. of animals per sex per dose:
- 6 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was noted during the 7 day observation period.
- Clinical signs:
- other: Animals were showing signs of stress within 1 hour after treatment, but had recovered within 18 hours.
- Gross pathology:
- Animals presented a normal apperance at autopsy, apart from one male mouse that appeared immature.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is >5 mL/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
- Executive summary:
In an acute oral toxicity study, a single oral dose of 5 mL/kg bw of the undiluted test substance was given to 6 mice. Animals were then observed for mortality and clinical signs of toxicity for 7 days.
No mortality was noted during the 7 day observation period. Animals were showing signs of stress within 1 hour after treatment, but had recovered within 18 hours. Animals gained weight and presented a normal apperance at autopsy, apart from one male mouse that lost 3 g and appeated immature at autopsy.
Mice Oral LD50 > 5 mL/kg bw.
Under the test conditions, the oral LD50 of the test substance is >5 mL/kg bw 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
- Quality of whole database:
- pre-GLP study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: via oral route
In an acute oral toxicity study, a single oral dose of 5 mL/kg bw of the undiluted test substance was given to 6 mice. Animals were then observed for mortality and clinical signs of toxicity for 7 days.
No mortality was noted during the 7 day observation period.
Mice Oral LD50 > 5 mL/kg bw.
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Acute toxicity via Oral route:
Based on the available information on Lavandin concrete, the registered substance is:
- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5 mL/kg bw
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