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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972-11-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972-11-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
study conducted before the implementation of GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Sample marking: RIFM 72-174
- Name: Jasmine Absolute
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
n.a.
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
n.a.
Duration of exposure:
14 days
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6 rabbits
Control animals:
no
Details on study design:
n.a.
Statistics:
n.a.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
No treatment related changes observed
Body weight:
n.a.
Gross pathology:
n.a.
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the dermal LD50 in rabbits after treatment with the test item is considered to be greater than 5000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study conducted similar to OECD 402, six rabbits were given dermally a single dose of the test item Jasmin absolute of 5000 mg/kg bw. The animals were observed for a total of 14 days. No mortality occurred during the observation period and no adverse signs of toxicity were recorded. In conclusion, the dermal LD50 in rats after treatment with the test item is greater than 5000 mg/kg bw.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
study conducted before the implementation of GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Absolute of Jasmine (Jasminum grandiflorum) obtained from Jasmine concrete by ethanol extraction
EC Number:
948-021-2
Molecular formula:
n.a.
IUPAC Name:
Absolute of Jasmine (Jasminum grandiflorum) obtained from Jasmine concrete by ethanol extraction
Specific details on test material used for the study:
- Sample marking: RIFM 72-174
- Name: Jasmine Absolute

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
n.a.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
n.a.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
n.a.
Statistics:
n.a.

Results and discussion

Preliminary study:
n.a.
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
2 out of 10 rats died overnight on Day 1 of the study.
Clinical signs:
Slow respiration and lethargy was observed
Body weight:
n.a.
Gross pathology:
n.a.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the oral LD50 in rats after treatment with the test item is considered to be greater than 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study conducted similar to OECD 401, ten rats were given a single oral dose of the test item Jasmine absolute at a dose of 5000 mg/kg bw. The animals were observed for a total of 14 days. Two animals died within one day after the treatment. In addition, slow respiration and lethargy were observed as clinical signs of toxicity. In conclusion, the oral LD50 in rats after treatment with the test item is greater than 5000 mg/kg bw.