Amyris balsamifera, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is a publication, that contains basic sufficient data for the assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

yes

Remarks:

Not all animals were of the same sex, no data on whether animals that died during the test were necropsied.

GLP compliance:

no

Remarks:

Not relevant

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Amyris balsamifera, ext.

EC Number:

291-076-6

EC Name:

Amyris balsamifera, ext.

Cas Number:

90320-49-3

Molecular formula:

Not applicable due to the UVCB nature of the substance.

IUPAC Name:

Essential oil of Amyris obtained from the wood of Amyris balsamifera (Rutaceae) trees by steam distillation.

Test material form:

liquid: viscous

Details on test material:

For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Amyris oil

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults
- Fasting period before study: 18 hrs
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Details on oral exposure: no data
- Doses: no data

No. of animals per sex per dose:

5 (per sex/per dose)

Control animals:

no

Details on study design:

- Duration of observation period following administration: two weeks
- Frequency of observations and weighing: no data ("close observation")
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: toxic signs and death

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 580 mg/kg bw

95% CL:

1.5

Mortality:

Death time: 1-3 days

Clinical signs:

other: Toxic signs included ataxia, coma within 1 hr, porphyrinlike deposit around eyes and nose. Wet posterior

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of Amyris oil is 5580 mg/kg bw.

Executive summary:

In this study, amyris oil was fed via intubation to 10 young rats (both male and female), which were fasted for approximately 18hr prior to treatment. All animals were monitored for toxic signs and time to death. The results show that the oral LD50 value of Amyris oil is 5580 mg/kg bw (95% confidence limit: 4540 -6860). The time to death was 1 -3 days. Toxic signs reported included ataxia, coma within 1 hr, porphyrinlike deposit around eyes and nose and wet posterior.

Based on the results obtained, it can be stated that in this study and under the experimental conditions reported, the test item Amyris oil does not need to be classified as acute toxic via oral exposure, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).