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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (non-GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Principles of method if other than guideline:
BASF-TEST: In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14- day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-cyano-3,5,5-trimethylcyclohexanone
EC Number:
411-490-4
EC Name:
3-cyano-3,5,5-trimethylcyclohexanone
Cas Number:
7027-11-4
Molecular formula:
C10 H15 N O
IUPAC Name:
3-cyano-3,5,5-trimethylcyclohexanone
Details on test material:
- Lot No.: 22298/133
- Purity: > 99.5%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil DAB 9
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg


Doses:
100, 215, 464, 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least once each workday
- Necropsy of survivors performed: yes
Statistics:
FINNEY, D.J., PROBIT ANALYSIS, CAMBRIDGE UNIVERSITY PRESS, 3RD ED., 1971

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
365 mg/kg bw
Mortality:
yes,
100 mg/kg bw: 0/5 females 0/5 males
215 mg/kg bw:1/5 females 1/5 males
464 mg/kg bw: 4/5 females 2/5 males
1000 mg/kg bw: 5/5 females 5/5 males
Clinical signs:
100 mg/kg bw: nothing abnormal detected
215 mg/kg bw: poor general state, dyspnoea, apathy, staggering lateral position, rolling convulsions, clonic convulsions, piloerection, smeared fur
464 mg/kg bw: poor general state, dyspnoea, apathy, staggering, lateral position, twitching, saltatory spasm, flexing spasm, spasm of jaws, rolling convulsions, clonic convulsions, piloerection, smeared fur, salivation, chromodacryorrhea
1000 mg/kg bw: poor general state, dyspnoea, apathy, staggering, atonia, paresis, lateral position, twitching, saltatory spasm, flexing spasm, spasm of jaws, roling convulsions, clonic convulsions, piloerection, smeared fur, salivation, chromodacryorrhea
Body weight:
not reported
Gross pathology:
Animals that died: general congestion
Sacrificed animals: no pathological findings

Applicant's summary and conclusion