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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: Animals were showing signs of stress within 1 hour after treatment, but had recovered within 18 hours.
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