Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP. Guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0,5% METHYLCELLULOSE
Duration of exposure:
24 h
No. of animals per sex per dose:
Three animals of one sex were used for each step. Males were used in the initial step. The dose-level used as the starting dose was selected from one of three fixed levels, 25, 200 or 2000 mg/kg body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 other: mg/kg

Any other information on results incl. tables

Mortality: Male: 5 rats; Number of deaths: 0

Fame: 5 rats; Number of deaths: 0

Clinical signs: No clinical signs and no cutaneous reactions were observe during the study.

Gross pathology: Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the oral LD50 of the test item Veralactame is higher than 2000 mg/kg in rats.
According to the clasification criteria laid down in Council Directive REACH 2006/121/CE (and subsequent adaptation) on the appoximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, and concerning the potencial toxicity by dermal route, the test item Veralactame should not be clasified.