Absolute of Jasmine (Jasminum grandiflorum) obtained from Jasmine concrete by ethanol extraction

Acute Toxicity: oral

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:

other: No treatment related changes observed

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

Test material information

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:

other: Slow respiration and lethargy was observed

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.