Essential oil of Copaiba obtained from the exudate of Copaifera (Fabaceae) trees by distillation

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Essential oil of Copaiba obtained from the exudate of Copaifera (Fabaceae) trees by distillation

EC Number:

946-913-6

Molecular formula:

Not applicable for UVCB Substance

IUPAC Name:

Essential oil of Copaiba obtained from the exudate of Copaifera (Fabaceae) trees by distillation

Test material form:

liquid

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): Copaiba oil, Copiaba Balsam oil, Copaiba oleoresin

Specific details on test material used for the study:

clear colorless liquid SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: research Institute for Fragrance Materials
-RIFM number: 56452

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (v/v)
- Justification for choice of vehicle: according to guideline

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxic signs and mortality were observed forllowing dosing at one and four hours, and once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:

Two aninals were given a single dose by gastric intubation. No deaths occured, so 8 additional animals were given the samen dose via the same route.

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: Signs of diahrrea, depression and piloerection were observed.

Gross pathology:

No gross findings

Applicant's summary and conclusion

Interpretation of results:

other: not classied

Remarks:

based on CLP criteria (Annex I 1272/2008/EC)

Conclusions:

The oral LD50 value of Copaiba balsam oil in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified for acute oral toxicity according to the criteria laid down in Annex I of 1272/2008/EC (CLP).

Executive summary:

The acute toxic potential of Copaiba Balsam oil was assessed in an acute oral toxicity limit test performed in 10 rats. The rats were exposed to 5000 mg/kg bw Copaibla balsam oil via the oral route, and observed for clinical signs and mortality over an examination period of 14 days. Observations were performed at one and four hours and daily thereafter. At the end of the study period no mortality was observed in any of the animals. Symptoms observed in the test animals were diarrhea, depression, piloerection. No gross findings were noted. The LD50 for acute oral toxicity was set at >5000 mg/kg bw.

Based on these results Copaiba Balsam oil does not have to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).