Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Suitable data is available to assess the acute toxicity of the target substance. In an acute oral and in an acute dermal toxicity study no mortality occurred after treatment with 5000 mg/kg bw. Thus, based on the results, the acute oral and dermal LD50 can be considered to be greater than 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reason / purpose for cross-reference:
reference to same study
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
Specific details on test material used for the study:
- Sample marking: RIFM 72-174
- Name: Jasmine Absolute
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
n.a.
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.
Preliminary study:
n.a.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Equivalent to guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Suitable data is available to assess the acute toxicity of the target substance. In an acute oral toxicity ten rats received a single dose of 5000 mg/kg bw. No mortality occurred during the 14 -day observation period. In an acute dermal toxicity study, six rabbits received dermally a single dose of 5000 mg/kg bw. No mortality occurred during the 14-day observation period. Thus, based on the results, the acute oral and dermal LD50 can be considered to be greater than 5000 mg/kg bw.

Justification for classification or non-classification

Based on the available data, no classification is warranted for acute toxicity.