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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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).