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: Study quoted in the EU risk assessment. However, details of the experimental design and original results are not presented in the report.

Data source

Reference
Reference Type:
publication
Title:
Acute and subacute toxicity of di(2-ethylhexyl) phthalate with note upon its metabolism.
Author:
Shaffer CB, Carpenter CP
Year:
1945
Bibliographic source:
J. Ind. Hyg. Toxicol. 27, 130-135

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Food and Drug Administration's cuff test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
20 ml/kg
No. of animals per sex per dose:
6 animals in total
Control animals:
not specified
Details on study design:
No data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 20 mL/kg bw
Remarks on result:
other: = 19800 mg/kg bw
Mortality:
20 ml/kg killed 2 of 6 rabbits.
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Executive summary:

Rabbits were exposed dermally for 24 hours with doses up to 20 ml/kg. That amount killed 2 of 6 rabbits. The LD50 by skin absorption is ca. 20 ml/kg (19800 mg/kg bw).