Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deviation from OECD-423 guideline, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP Certificate as an annexe in the study report.
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Doses:
2000 mg/kg body weight.
No. of animals per sex per dose:
3 animals per sex per dose.
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality occured during the study, LD50 of APPyclean-6505 is higher than 2000 mg/kg bw by oral route in the rat.
Executive summary:

No mortality occured during the study. No clinical signs related to administration of the test product were observed. The body weight evolution remained normal througout the study, similar between treated and control animals. The LD50 of APPyclean-6505 is higher than 2000 mg/kg bw by oral route in the rat. No classification is needed.