Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Principles of method if other than guideline:
Standard acute method
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Laurus nobilis, ext.
EC Number:
283-272-5
EC Name:
Laurus nobilis, ext.
Cas Number:
84603-73-6
IUPAC Name:
Laurus nobilis, ext.
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Laurel leaf oil
- Sample marking: 73-97

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
2050, 3200, 5000 and 7730 mg/kg bw
No. of animals per sex per dose:
10 animals/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None

Results and discussion

Preliminary study:
none
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 950 mg/kg bw
Based on:
test mat.
95% CL:
3 170 - 4 740
Remarks on result:
other: No mortality was observed at 2050 mg/kg bw. Mortality was observed in 4/10, 7/10 and 10/10 animals at 3200, 5000 and 7730 mg/kg bw, respectively.
Mortality:
- No mortality was observed at 2050 mg/kg bw.
- Mortality was observed in 4/10, 7/10 and 10/10 animals at 3200, 5000 and 7730 mg/kg bw, respectively.
Clinical signs:
- At 2050 mg/kg bw, piloerection; at 3200 and 5000 mg/kg bw, lethargy; at 7730 mg/kg bw, piloerection, lethargy and loss of righting reflex in 5/10 animals were observed.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the oral LD50 for Laurel leaf oil is 3950 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).
Executive summary:

In an acute oral toxicity study, group of 10 rats/dose were given a single oral dose of Laurel leaf oil at 2050, 3200, 5000 and 7730 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.

No mortality was observed at 2050 mg/kg bw. Mortality was observed in 4/10, 7/10 and 10/10 animals at 3200, 5000 and 7730 mg/kg bw, respectively. At 2050 mg/kg bw, piloerection; at 3200 and 5000 mg/kg bw, lethargy; at 7730 mg/kg bw, piloerection, lethargy and loss of righting reflex in 5/10 animals were observed. In this study, the oral LD50 of test item was 3950 mg/kg bw in rats.  

Under the test conditions, the oral LD50 for Laurel leaf oil is 3950 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).