5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde oxime

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.3

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde oxime

EC Number:

944-572-8

Molecular formula:

C18H29NO2 - C19H31NO2 (main constituents)

IUPAC Name:

5-(C11-C12 alkyl, branched)-2-hydroxy-benzaldehyde oxime

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.