Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
NA
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ISO 10993 standard, part 11
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
They have different version of synthesis based on scale (small, medium, large) There is differences between dirrerent scales are related to materials physical properties.

Test animals

Species:
mouse
Strain:
other: OF1 Ico
Sex:
female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: 0.9% NaCl
Details on exposure:
Sterile Upsalite® powder was extracted for 72 ± 2 hours at 50˚C in stirred solutions of 0.9% NaCl . The ratio between the material and the extraction vehicle was 0.2 g/ml. The extracts were stored at room temperature before use for a maximum of 24 hours, and shaken immediately before use to ensure homogeneity of the extract.
Doses:
The ratio between the material and the extraction vehicle was 0.2 g/ml. Five female mice (OF1 Ico) per extract were injected at a dose of 50 ml/kg using the intrapertioneal (IP) route.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
The mice were observed for adverse reactions immediately after dosing (T0) and after 4, 24, 48 and 72 hours and were also weighted 24, 48 and 72 hours after the injection.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
ca. 0.01 mg/kg bw
Based on:
test mat. (total fraction)
Remarks on result:
other: NaCl Extract
Mortality:
There was no mortality.
Body weight:
The animal body weight for the 0.9% NaCl extract groups increased and there was no significant difference between the treatment and control group.

Applicant's summary and conclusion

Conclusions:
As well, there was no evidence of significant systemic toxicity when saline extracts of Upsalite® were injected in mice.