Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
publication
Title:
Studies of the acute and chronic toxicity of undecylenic acid
Author:
Newell GW et al.
Year:
1949
Bibliographic source:
J. Invest. Dermatol. 1949 ; 13 : 145-14

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data on source and purity

Test animals

Species:
mouse
Strain:
other: Carworth CF1
Sex:
male/female
Details on test animals and environmental conditions:
no data on source and age;
weight at sudy initiation: 18- 22g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: sesame oil
Doses:
11, 16, 20, 24 and 36 mg
No. of animals per sex per dose:
30
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
953 - 967 mg/kg bw
Mortality:
see table 1
Clinical signs:
no data
Gross pathology:
No obvious target organ

Any other information on results incl. tables

Table 1: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/mouse)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

Control

 

 

 

 

 

 

 

11

 

 

 1/6

 

 

 

 

16

 

 

0/6 

 

 

 

 

20

 

 

5/6 

 

 

 

 

24

 

 

6/6 

 

 

 

 

 36      6/6        

Applicant's summary and conclusion

Executive summary:

The acute toxicologic potential of Undecylenic Acid was evaluated in the mouse in a procedure similar to OECD guideline 401. The test substance was applied intraperitoneally. The calculated LD50 was 960 mg/kg bw for intraperitoneal administration.

First results of an ongoing chronic toxicity are reported, but the study was not finished at the timepoint of reporting.