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Description of key information

Acute oral toxicity

The acute oral toxicity in rats was determined according to the method recommended in OECD Guidelines 420 "Fixed dose method" from 1992.

The study was initiated with a sighting study. On the basis of the results of the sighting study, it was decided to carry out main study with dose of 5000 mg /Kg bw with a group of 10 animals.

Eight animals of the main study survived the treatment and showed moderate signs of toxicity

Under the experimental conditions described, the oral LD50 of the test item in rats was found to be >5000 mg/Kg bw

A supporting study where one group of rats (5 males and 5 females) received 1 oral dose of Sandalmysore Core at 5000 mg/Kg bw was also used to assess acute oral toxicity. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Macroscopic examination of one female found dead showed a yellowish intestinal content. Since only 1 animal died, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg bodyweight.

Acute dermal toxicity

The acute dermal toxicity of the substance was assessed according to OECD 402. One group of Wistar rats, comprising 5 males and 5 females, was treated with a single dermal dose of the test item at 2000 mg/kg bodyweight for 24 hours. No mortalities occurred and no signs of systemic toxicity were observed during exposure and the following 14 -day observation period.

The treated skin surface of the animals showed areas with erythema and scales. These lesions disappeared during the second week of observation. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 2.0 g/body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 30/4/1996 to 2/7/1996
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
Sighting study:
2000 mg/Kg bw and 5000 mg/Kg bw
Main study:
5000 mg/Kg bw (10 mL/Kg bw
No. of animals per sex per dose:
Sighting study:
2 rats
Main study:
5 males and 5 females
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 of the test item in rats was found to be >5000 mg/Kg bw
Executive summary:

The acute oral toxicity in rats was determined according to the method recommended in OECD Guidelines 420 "Fixed dose method" from 1992.

The study was initiated with a sighting study. On the basis of the results of the sighting study, it was decided to carry out main study with dose of 5000 mg /Kg bw with a group of 10 animals.

Eight animals of the main study survived the treatment and showed moderate signs of toxicity

Under the experimental conditions described, the oral LD50 of the test item in rats was found to be >5000 mg/Kg bw

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
from 25/06/1986 to 13/08/1986
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
other: stainless steel stomach canula
Vehicle:
unchanged (no vehicle)
Doses:
Dose range finding :
320, 560, 1000, 1800, 3200 and 5600 mg/Kg bodyweight
Main study:
5000 mg/Kg bodyweight
No. of animals per sex per dose:
Dose range finding:
3 groups of animals (each 1 male and 1 female)
Main study:
5 males and 5 females
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

see attachment

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value for males and females combined was estimated to exceed 5.0 g/kg bodyweight
Executive summary:

one group of rats (5 males and 5 females) received 1 oral dose of Sandalmysore Core at 5000 mg/Kg bw

Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Macroscopic examination of one female found dead showed a yellowish intestinal content. Since only 1 animal died, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg bodyweight

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

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:
from 01/10/1986 to 15/10/1986
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
as adopted on 12th May 1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
one group of animals, comprising 5 males and 5 females, was treated with a single dermal dose of the test substance at 2000 mg/kg of bodyweight
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

see attachement

Interpretation of results:
GHS criteria not met
Conclusions:
The test item should not be classified for acute dermal toxicity in accordance with GHS system and CLP regulation Regulation (EC) No 1272/2008
Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, was treated with a single dermal dose of the test item at 2000 mg/kg bodyweight for 24 hours. No mortalities occurred and no signs of systemic toxicity were observed during exposure and the following 14 -day observation period.

The treated skin surface of the animals showed areas with erythema and scales. These lesions disappeared during the second week of observation. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 2.0 g/body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

In the CLP regulation acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

The substance does not meet the criteria for classification under the CLP regulations for acute toxicity via the oral route based on the result of an acute oral toxicity study, which gave a LD50 of > 5000 mg/kg bodyweight, which is above the classification cut-off value ( ≤2000 mg/kg bodyweight) for acute oral toxicity.

The substance does not meet the criteria for classification under the CLP regulations for acute toxicity via the dermal route based on the result of a dermal toxicity study, which gave a LD50 of > 2000 mg/kg bodyweight, which is above the classification cut-off value ( ≤2000 mg/kg bodyweight) for acute dermal toxicity.