Registration Dossier

Administrative data

Description of key information

The acute oral toxicity of Mesamoll was tested in male Wistar rats treated via gavage with the doses: 5.0 and 15.0 ml/kg bw. The observation period was 14 days. No mortalities could be observed. Signs of intoxication were observed in the 15.0 ml/kg bw dose group (apathy, ruffled fur and diarrhea). The LD 50 was higher than 15 ml/kg bw (corresponds to 15.9 g/kg) (Löser E. / Kimmerle G., Bayer AG, 1975).
No acute inhalation study is available for Mesamoll.
In an acute dermal toxicological study Mesamoll was applied once to the shaved skin of the back of male and female Wistar rats. The observation time was 7 days and during this time period the test substance was not removed from the animals. No mortalities and no symptoms of toxicity could be observed. Therefore, regarding the density of Mesamoll (1.055 g/cm³ at 20 °C), the LD 50 was higher than 1055 mg/kg bw (Löser E. / Kimmerle G., Bayer AG, 1975).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on purity of test sample, non-GLP
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Acute oral toxicity in male rats
GLP compliance:
not specified
Test type:
other: Acute oral toxicity in male rats
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Route of administration:
oral: gavage
Vehicle:
other: none
Doses:
5.0; 15.0 ml/kg bw.
No. of animals per sex per dose:
10 male rats/dose
Control animals:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 15 mL/kg bw

 Dose (ml/kg bw)  Timepoint of death  Toxicological result (No.of mortalities/ Animals with Symptoms/ No.of animals)

 5.0

 -

0/0/10 

 15.0

 -

 0/10/10

Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral toxicity of Mesamoll was tested in male Wistar rats treated via gavage with the doses: 5.0 and 15.0 ml/kg bw. The observation period was 14 days. No mortalities could be observed. Signs of intoxication were observed in the 15.0 ml/kg bw dose group (apathy, ruffled fur and diarrhea). The LD 50 was higher than 15 ml/kg bw (corresponds to 15.9 g/kg).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined; no data on purity of test sample.
Principles of method if other than guideline:
Acute percutan toxicity in male and female rats.
GLP compliance:
not specified
Test type:
other: acute percutan toxicity in male and female rats.
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
7 d
Doses:
1.0 ml/kg bw.
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Key result
Dose descriptor:
LD50
Effect level:
> 1 055 mg/kg bw

 Dose (ml/kg bw)  sex  Timepoint of death  Toxicological result (No. of mortalities/ Animals with symptoms/ No.of animals)
 1.0  male  -  0/0/5
 1.0  female  -  0/0/5
Interpretation of results:
GHS criteria not met
Executive summary:

In this acute dermal toxicological study Mesamoll was applied once to the shaved skin of the back of male and female Wistar rats

(160 -180 g). The observation time was 7 days and during this timeperiod the test substance was not removed from the animals. No mortalities and no symptoms of toxicity could be observed. Therefore, regarding the density of Mesamoll ( 1.055 g/cm³ at 20 °C),

the LD 50 was higher than 1055 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose

Additional information

Conclusion: Overall Mesamoll shows no lethal effect after acute intake in the doses tested.

Justification for classification or non-classification

Classification is not required due to low acute toxicity.