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 deviation from OECD-402 guideline, but is not GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
But procedure follows GLP requirements.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Duration of exposure:
48h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

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:
Dermal acute tox in rat can be considered as higher than 2000 mg/kg bw for APPyclean-6669 (called previously "Xyliance").
Executive summary:

No mortality and absolutely no clinical signs occured during the study with APPyclean-6669 (APP C16-18). Dermal acute tox can be considered as higher than 2000 mg/kg bw by dermal route in rat. No classification is needed. Please see full details about the absence of rat acute toxicity in APP category report.