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REACH

Laurus nobilis, ext.

EC number: 283-272-5 | CAS number: 84603-73-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Laurus nobilis, Lauraceae.

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

Acute toxicity, oral: LD50 = 3950 mg/kg bw (K, Rel.2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

Standard acute method

GLP compliance:

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

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:

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

None

Preliminary study:

none

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

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.

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed
Dose descriptor:: LD50
Value:: 3 950 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

Endpoint conclusion

Endpoint conclusion:: no study available

Additional information

Acute toxicity: via oral route:

A key study was identified (Moreno, 1974, Rel. 2). In this 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.

Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for classification or non-classification

Harmonized classification:

Laurel leaf oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the typical composition provided by the Lead Registrant, Laurel leaf oil is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is greater than 2000 mg/kg bw.

Acute toxicity via Dermal route: This information is not available

Acute toxicity via Inhalation: This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal): This information is not available.

Specific target organ toxicity: single exposure (Inhalation): This information is not available.

Based on the typical composition provided by the Lead Registrant (> 10% of aspiration toxicants, i.e. limonene, pinene), Laurel leaf oil should be classified for aspiration hazard:

- H304,May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008

- Xn, R65, Harmful: may cause lung damage if swallowed according to the Directive 67/548/EEC.

Source: ECHA disseminated dossiers

-Pinene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html

- Limonene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html

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