Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

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

Results and discussion

Effect levels
Key result
Dose descriptor:
LD50
Effect level:
> 1 055 mg/kg bw

Any other information on results incl. tables

 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

Applicant's summary and conclusion

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.