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Administrative data

Description of key information

Acute toxicity, oral in mouse: LD50 > 5 mL/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel.2)

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no data about purity and no certificate of analysis of the test substance; no data on strain/sex of animals dosed; environmental conditions not reported; 7 days observation period
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data about purity and no certificate of analysis of the test substance; no data on strain/sex of animals dosed; environmental conditions not reported; 7 days observation period
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
None
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Fasting period before study: 4 hours
- Diet fed after treatment: Commercial stock diet
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
None
Doses:
5 mL/kg bw
No. of animals per sex per dose:
6 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight
Statistics:
No data
Preliminary study:
Not applicable
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
No mortality was noted during the 7 day observation period.
Clinical signs:
Animals were showing signs of stress within 1 hour after treatment, but had recovered within 18 hours.
Body weight:
Animals gained weight during the 7 day observation period, apart from one male mouse that lost 3 g.
Gross pathology:
Animals presented a normal apperance at autopsy, apart from one male mouse that appeared immature.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 of the test substance is >5 mL/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
Executive summary:

In an acute oral toxicity study, a single oral dose of 5 mL/kg bw of the undiluted test substance was given to 6 mice. Animals were then observed for mortality and clinical signs of toxicity for 7 days.

 

No mortality was noted during the 7 day observation period. Animals were showing signs of stress within 1 hour after treatment, but had recovered within 18 hours. Animals gained weight and presented a normal apperance at autopsy, apart from one male mouse that lost 3 g and appeated immature at autopsy.

 

Mice Oral LD50 > 5 mL/kg bw.

 

Under the test conditions, the oral LD50 of the test substance is >5 mL/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
pre-GLP study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: via oral route

In an acute oral toxicity study, a single oral dose of 5 mL/kg bw of the undiluted test substance was given to 6 mice. Animals were then observed for mortality and clinical signs of toxicity for 7 days.

 No mortality was noted during the 7 day observation period.

Mice Oral LD50 > 5 mL/kg bw.

 

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information on Lavandin concrete, the registered substance is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5 mL/kg bw