Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
toxicity to microorganisms
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-12-14 to 1998-12-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: DIN 38412, part 8, March 1991
Deviations:
no
GLP compliance:
yes

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:
C10H15NO
IUPAC Name:
3-cyano-3,5,5-trimethylcyclohexanone
Details on test material:
Test substance: Isophorone nitrile of Degussa AG, batch no. 25.9.98/ANT, purity: 99.8 %

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
STOCK AND TEST SOLUTION AND THEIR PREPARATION
- Dispersion: Crushing in mortar, ultrasonication for 40 minutes
- Concentration of vehicle/ solvent: no vehicle or solvent

Test organisms

Test organisms (species):
Pseudomonas putida
Details on inoculum:
TEST ORGANISMS
- Strain: Pseudomonas putida Migula, strain Berlin
- Source/supplier: DSM (Deutsche Stammsammlung von Mikroorganismen und  Zellkulturen GmbH), Braunschweig (Germany)

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
16 h
Remarks on exposure duration:
+/- 1 hour

Test conditions

Test temperature:
- Test temperature: 20 +- 2 °C
pH:
- pH: 5.95 - 6.94
Nominal and measured concentrations:
125; 250; 500; 1000; 2000 mg/l (nominal concentrations), selection based on pre-test with 100; 1000; 4000 mg/l
Details on test conditions:
TEST SYSTEM
- Renewal of test solution: no
- Exposure vessel type: 300 ml Erlenmeyer flask, closed allowing the  transport of oxygen
- Number of replicates: 3 inoculated + 1 uninoculated
- Controls (No. of replicates): 10 inoculated + 1 uninoculated

TEST PARAMETER
- bacterial density measured by light absorption at 436  nm with Perkin Elmer Lambda 2 photometer

VALIDITY CRITERIA
- The optical density must increase by a factor of > 100  during the incubation time of 16 +- 1 h.

Results and discussion

Effect concentrationsopen allclose all
Duration:
16 h
Dose descriptor:
NOEC
Effect conc.:
68 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Duration:
16 h
Dose descriptor:
EC10
Effect conc.:
96 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Duration:
16 h
Dose descriptor:
EC50
Effect conc.:
390 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Duration:
16 h
Dose descriptor:
EC100
Effect conc.:
2 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition

Any other information on results incl. tables

- Observed inhibition with test substance:
   125 mg/l: 11 %
   250 mg/l: 37 %
   500 mg/l: 56 %
  1000 mg/l: 82 %
  2000 mg/l: 95 %

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The EC50 for the inhibition of cell growth of Pseudomonas putida is 390 mg/L indicating that the test substance does not pose a significant hazard toaquatic organisms
Executive summary:

Isophorone nitrile was investigate regarding its chronic toxic effects on bacteria (Pseudomonas putida) according to DIN 38412, part 8. Five concentrations ranging from 125 mg/L to 2000 mg/L were tested over a period of 16 hours. The following endpoints were derived:

EC10 (16 hours): 96 mg/L

EC 50 (16 hours): 390 mg/L

The study was assessed as "reliable without restrictions".