Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment supported with ToxRTool (Schneider, K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10:189(2):138-44)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: 16 CFR 1500.3
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RD 5893; Dodecylsalicylaldoxime
- Physical state: dark yellow, semi-solid viscous liquid

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
0.5, 0.89, 1.58, 2.81 and 5.0 g/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 220 mg/kg bw
95% CL:
>= 1 060 - <= 1 410
Mortality:
Dose [g/kg] mortality
0.50 0/10
0.89 2/10
1.58 7/10
2.81 10/10
5.00 10/10
Clinical signs:
For all concentrations salivation, decreased activity, ataxia, bloody nasal discharge, diarrhoea were observed to a varoius degree
Body weight:
Body weight increase of surviving rats was normal.
Gross pathology:
Necropsy was performed in all rats that died during the study.
Lungs: pale and mottled
Spleen: pale and in the two highest concentration granular or dark in some rats
Kidney: pale and in the two highest concentration mottled or dark in some rats
Intestine: contains yellow (viscous) liquid; vascularised
Gastrointestinal tract: contains yellow (viscous) liquid; vascularised (higest concentration only)
Liver: dark in a few rats in the two highest concetrations
Other findings:
none stated

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
With an LD50 of 1220 mg/kg bodyweight, the test substance is considered as acute toxic Category 4.
Executive summary:

The test substance was assessed for its acute oral toxicity using the OECD 401 protocol. Four dose levels between 0.5 and 5 g/kg bw were applied to SD rats and a control group receiving the vehicle was assigned. 5 male and 5 female animals were assigned to each dose group. The LD50 was determined to be 1220 mg/kg bodyweight using a linear regression model. The test substance is assigned to acute toxic Category 4.