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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1973
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-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Absolute of Dipteryx odorata (Fabaceae) obtained from beans by organic solvents treatment and subsequent ethanol extraction
EC Number:
951-766-6
Molecular formula:
Not relevant, UVCB substance
IUPAC Name:
Absolute of Dipteryx odorata (Fabaceae) obtained from beans by organic solvents treatment and subsequent ethanol extraction
Test material form:
other: Crystal

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:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
840, 1310, 2050, 3200 and 5000 mg/kg bw
No. of animals per sex per dose:
10 animals/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 1 380 mg/kg bw
Based on:
test mat.
95% CL:
> 1 040 - < 1 720
Mortality:
- At 840 mg/kg bw: 1/10
- At 1310 mg/kg bw: 7/10
- At 2050 mg/kg bw: 9/10
- At 3200 mg/kg bw: 8/10
- At 5000 mg/kg bw: 10/10
Clinical signs:
other: - At 840 mg/kg bw: piloerection - At 1310 and 2050 mg/kg bw: lethargy and piloerection - At 3200 and 5000 mg/kg bw: lethargy, ataxia and loss of righting reflex.
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the test conditions, the oral LD50 for test substance is 1380 mg/kg bw in rats. Therefore the test substance is classified as harmful if swallowed according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study, Tonka Absolute was administered by oral route at a dose level of 840, 1310, 2050, 3200 and 5000 mg/kg bw in rats (ten/dose). Animals were observed for mortality and clinical signs for 14 days.

Mortality was observed at all tested doses. Piloerection, Lethargy, ataxia and loss of righting reflex were observed. In this study, the oral LD50 of Tabac absolute was 13800 mg/kg bw in rats.

Under the test conditions, the oral LD50 for test substance is 1380 mg/kg bw in rats. Therefore the test substance is classified as harmful if swallowed according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.