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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: 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 wi
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).