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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:
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.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Rats were given a single oral dose of test substance at 5000 mg/kg bw and then observed for 14 days.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Rose, Rosa damascena, ext.
EC Number:
290-260-3
EC Name:
Rose, Rosa damascena, ext.
Cas Number:
90106-38-0
IUPAC Name:
Absolute of Rosa Damascena (Rosaceae) obtained from fresh rose flowers by extraction with an apolar solvent followed by an extraction with ethanol
Specific details on test material used for the study:
- Sample marking: 72-220
- Name of test material: rose absolute French

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5 g/kg bw
No. of animals per sex per dose:
No data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and clinical signs at least daily for 14 days

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
3/10 animals on Day 2
Clinical signs:
Piloerection, lethargy
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272-2008 and GHS.
Executive summary:

In an acute oral toxicity study (limit test), 10 rats were given a single oral dose of rose absolute French at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs at least daily for 14 days.

Three out of 10 animals died on Day 2. Piloerection and lethargy were observed. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according the Regulation (EC) N° 1272-2008 and GHS.