Registration Dossier

Diss Factsheets

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
review article or handbook
Title:
Range-finding toxicity data: List IV
Author:
Smyth H.F. et al.
Year:
1951
Bibliographic source:
Archiv. Industr. Hyg. Occup. Med. 4: 119-122

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Penetration of rabbit skin is estimated by a technique closely akin to the one-day, cuff Method of Draize and associates using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 ml/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) adipate
EC Number:
203-090-1
EC Name:
Bis(2-ethylhexyl) adipate
Cas Number:
103-23-1
Molecular formula:
C22H42O4
IUPAC Name:
bis(2-ethylhexyl) adipate

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
16 300 mL/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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