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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Nature of substance: ESACURE 1001

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
The test article was mixed to a paste using 1.5 ml of sterile water.
Duration of exposure:
24 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: None
Gross pathology:
Effects on organs: None
Other findings:
Signs of toxicity (local): None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute dermal toxicity of the test material has been determined to have an LD50 value of >2000 mg/kg/bw.