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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically aceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Principles of method if other than guideline:
Single oral application of different doses to rats and observation for 7 days for symptoms and mortality; determination of LD50 according to Litchfield and Wicoxon
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexylamine
EC Number:
203-629-0
EC Name:
Cyclohexylamine
Cas Number:
108-91-8
Molecular formula:
C6H13N
IUPAC Name:
cyclohexanamine
Details on test material:
no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
male Wistar rats with body weights ranging between 150 and 200 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2% of the body weight

Doses:
25, 50, 100, 250, 300, 350, 500, 600, 750, 1000 mg/kg bw
No. of animals per sex per dose:
15
Control animals:
no
Details on study design:
Single oral application of different doses to male rats and observation for 7 days for symptoms and mortality; determination of LD50 according to Litchfield and Wicoxon
Statistics:
determination of LD50 according to Litchfield and Wicoxon

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 432 mg/kg bw
95% CL:
>= 376 - <= 496
Sex:
male
Dose descriptor:
other: NOAEL
Effect level:
ca. 25 mg/kg bw
Mortality:
---25, 50, 100, 250 mg/kg bw : no mortality
---one day after application
300 mg/kg bw: 2/15
350 mg/kg bw: 4/15
500 mg/kg bw 9/15
600 mg/kg bw: 13/15
750, 1000 mg/kg bw 15/15
Clinical signs:
25 mg/kg bw: no clinical signs,
50, 100 mg/kg bw start 1 hour post application and end within 2 days post application
250, 300, 350, 500, 600 mg/kg bw start within 30 min post applicatio and end within 5 days after application
750, 1000 mg/kg bw start within a few minutes post application end: death
Body weight:
at study initiation: 150-200 mg no further information
Gross pathology:
not done
Other findings:
no further data

Any other information on results incl. tables

no further data

Applicant's summary and conclusion

Executive summary:

Single oral application of 25, 50, 100, 250, 300, 350, 500, 600, 750, 1000 mg/kg bw Cyclohexylamindiluted in Lutrol yielded a LD50 value of 432 mg/kg bw . 25 mg/kg bw was tolerated without clinical signs and without mortality (NOAEL) whereas at 750 mg/kg bw and at 1000 mg/kg bw all rats died within few minutes post application (Bayer AG 1968).