Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deviation from OECD-401 guideline and GLP. The substance belongs to the category and is very close (alkylchain is also C16-18 but sugar is a mixture of glucose and xylose instead of xylose only).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP Certificate as an annexe in the study report.
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
Emuliance belongs to the APP category and is very close to Appyclean-6669 (alkylchain is also C16-18 but the ratio C16/C18 is 70/30 (instead of 30/70) and the sugar is a mixture of glucose and xylose (instead of xylose only). These differences are not expected to influence this endpoint.

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5 animals per sex per dose.
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 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 with an alkylpolypentosides C16-18 "Emuliance", LD50 of APPyclean-6669 (APP C16-18) can be considered as higher than 5000 mg/kg bw by oral route in rat.
Executive summary:

No mortality occured during the study with an alkylpolypentosides C16-18 "Emuliance". 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 macroscopical examination at the end of the study did not reveal treatment-related changes. The LD50 of APPyclean-6669 (C16-18) can be considered as higher than 5000 mg/kg bw by oral route in the rat. No classification is needed. Please see full details about the absence of rat oral acute toxicity of alkylpolypentosides in APP category report.