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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data from publication

Data source

Reference
Reference Type:
publication
Title:
Neurophysiological Studies on the Relation between the Structural Properties and Neurotoxicity of Aliphatic Hydrocarbon Compounds in Rats
Author:
J. Misumi and M. Nagano
Year:
1984
Bibliographic source:
British Journal of Industrial Medicine Vol. 41, No. 4 (Nov., 1984), pp. 526-532

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
The repeated dose toxicity test was conducted on Donryu rats exposed for 21 weeks subcutaneously with dose concentration of 400 mg/kg/day
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
111-13-6
IUPAC Name:
111-13-6
Constituent 2
Reference substance name:
Octan-2-one
EC Number:
203-837-1
EC Name:
Octan-2-one
Cas Number:
111-13-7
IUPAC Name:
octan-2-one
Details on test material:
- Name of test material: Octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.21 g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): 97% v/v

Test animals

Species:
rat
Strain:
other: Donryu
Sex:
not specified
Details on test animals or test system and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation:200-300 gm
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum):Standard pellet diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: : No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): : No data available
- Humidity (%):: No data available
- Air changes (per hr): : No data available
- Photoperiod (hrs dark / hrs light): : No data available

Administration / exposure

Type of coverage:
other: Subcutaneous injections
Vehicle:
not specified
Details on exposure:
No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
21 weeks
Frequency of treatment:
Daily dose ,5 days per week for 21 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
400 mg/kg
Basis:
no data
No. of animals per sex per dose:
7 rats
Control animals:
not specified
Details on study design:
No data available
Positive control:
No data available

Examinations

Observations and examinations performed and frequency:
No data available
Sacrifice and pathology:
Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: no data

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Every third day

DERMAL IRRITATION (if dermal study): No data

BODY WEIGHT: Yes
- Time schedule for examinations: Every third day

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: No data
.

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: Yes

- Time schedule for examinations: No data
- Dose groups that were examined:Test group(4-00 mg/kg/day)
- Battery of functions tested: sensory activity / grip strength / motor activity / other:Maximum conduction velocity ofmotor,sensory fibres,motor distal latency in the tail nerve of the rats was determined

Other examinations:
No data available
Statistics:
Difference between mean values for the treated and control group was tested by student’s t test

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Clinical signs: No effect on following parameter was observed when tested: Effect on growth,Dullness in movement,Difficulty in walking,paralysis in hind limbs. No salivation was observed in test group.
Dermal irritation:
not specified
Mortality:
mortality observed, treatment-related
Description (incidence):
Clinical signs: No effect on following parameter was observed when tested: Effect on growth,Dullness in movement,Difficulty in walking,paralysis in hind limbs. No salivation was observed in test group.
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
Neurobehaviour
No effect of chemical on nerve conduction velocity and motor distal latency was observed as compared to control
Motor conduction velocity Sensory conduction velocity Distal latency
Whole proximal Distal
Control 100 100 100 100 100
2-octanone 100 102 101 103 92

Effect levels

Dose descriptor:
NOAEL
Effect level:
400 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: Clinical signs,Motor conduction velocity,sensory conduction velocity

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The No observed adverse effect level (NOAEL) was found to 400 mg/kg in chronic study when exposed to rat for 21 weeks with dose concentration of 400 mg by subcutaneous route daily for 5 days per week.
Executive summary:

The chronic toxicity study was conducted on chemical 2-octanone exposed to rat .The test chemical was administered subcutaneously in daily dose of 400 mg/kg .weighing 200-300 g,5 days per week for a period of 21 weeks.Treated animals failed to show any changes in clinical sign and there isno change in nerve conduction velocity and motor distal latency was observed. Hence, The No observed adverse effect level (NOAEL) was found to 400 mg/kg in chronic study when exposed to rat for 21 weeks with dose concentration of 400 mg by subcutaneous route for 5 days per week.