Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-602-8 | CAS number: 85-40-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Standard test method used (OECD test guideline) GLP statement
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2,3,6-tetrahydrophthalimide
- EC Number:
- 201-602-8
- EC Name:
- 1,2,3,6-tetrahydrophthalimide
- Cas Number:
- 85-40-5
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): P2008
- Analytical purity: 97.70%
- Impurities (identity and concentrations): Tetrahydrophthalic anhydride D3 - 0.02%; Tetrahydrophthalic anhydride D4 - 0.05%;
Tetrahydrophthalimide D3 - 1.48%; Tetrahydrophthalimide D4 isomer - 0.75%
- Lot/batch No.: 1801
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 fraction prepared from the liver of rats treated with a single i.p. injection of Aroclor 1254 at 500 mg/kg. The S-9 mix used contained S-9 fraction and a cofactor solution
- Test concentrations with justification for top dose:
- Experiment 1: With and without S-9 mix: 8.0, 40, 200, 1000 and 5000 micrograms/plate
Experiment 2: With and without S-9 mix: 312.5, 625, 1250, 2500 and 5000 micrograms/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (0.1 mL per 2 mL medium)
- Justification for choice of solvent/vehicle: Commonly used agent allowing solubilisation of the test substance
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- for TA100 and TA1535 in absence of S9
- Positive control substance:
- 9-aminoacridine
- Remarks:
- for TA1538 in absence of S9
- Positive control substance:
- other: 4-Nitro-O-phenylenediamine
- Remarks:
- for TA1538 in absence of S9
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- for TA98 in absence of S9
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- for TA1535 in presence of S9
- Positive control substance:
- 9-aminoacridine
- Remarks:
- for TA98, TA100, TA1537 and TA1538 in presence of S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): Histidine deficient medium
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
Other - thinning of background lawn - Evaluation criteria:
- Positive response: Substance induces a dose-related and statistically significant increase mutation rate in one of more strains of bacteria in the
presence and/or absence of S9 in both experiments at sub-toxic concentrations
Negative response: Number of induced revertants, compared to spontaneous revertants, less than two-fold at each concentration examined - Statistics:
- UKEMS recommended methods
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results
|
|||||||
Experiment 1: Without S9 mix |
|||||||
Concentration |
Number of revertants (colonies/plate) |
||||||
Treatment |
(microgram/plate) |
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||
0 |
139.0 |
12.7 |
21.0 |
22.7 |
13.7 |
||
8 |
125.3 |
18.0 |
22.7 |
27.3 |
12.3 |
||
Test |
40 |
118.0 |
12.0 |
25.3 |
19.3 |
13.7 |
|
substance |
200 |
117.7 |
17.7 |
25.3 |
24.0 |
12.3 |
|
1000 |
118.7 |
15.3 |
22.0 |
23.7 |
14.0 |
||
5000 |
123.3 |
16.0 |
20.3 |
25.0 |
13.0 |
||
N-ethyl-N’-nitro-N-nitrosoguanidine |
536.3 |
109.7 |
- |
- |
- |
||
Positive |
4-nitro-O-phenylenediamine |
- |
- |
412.0 |
- |
- |
|
controls |
4-nitroquinoline N-oxide |
- |
- |
- |
184.0 |
- |
|
9-aminoacridine |
- |
- |
- |
- |
352.0 |
||
Experiment 1: With S9 mix |
|||||||
Concentration |
Number of revertants (colonies/plate) |
||||||
Treatment |
(microgram/plate) |
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||
0 |
147.3 |
19.0 |
23.3 |
36.0 |
11.0 |
||
8 |
137.3 |
19.7 |
27.3 |
31.7 |
9.0 |
||
Test |
40 |
144.0 |
18.7 |
25.3 |
31.7 |
12.0 |
|
substance |
200 |
133.3 |
20.7 |
25.0 |
34.0 |
10.7 |
|
1000 |
140.0 |
22.7 |
22.0 |
34.7 |
12.3 |
||
5000 |
132.0 |
14.7 |
25.0 |
29.7 |
14.3 |
||
Positive |
Benzo(a)pyrene |
517.0 |
- |
225.7 |
525.0 |
179.7 |
|
controls |
2-aminoantracene |
- |
236.3 |
- |
- |
- |
|
Experiment 2: Without S9 mix |
|
||||||
Concentration |
Number of revertants (colonies/plate) |
||||||
Treatment |
(microgram/plate) |
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||
0 |
124.7 |
14.7 |
13.0 |
18.0 |
11.3 |
||
312.5 |
103.3 |
13.7 |
15.0 |
19.0 |
13.7 |
||
Test |
625 |
101.0 |
14.0 |
16.7 |
19.3 |
10.3 |
|
substance |
1250 |
102.7 |
13.3 |
10.3 |
19.0 |
11.7 |
|
2500 |
94.7 |
13.7 |
13.0 |
19.3 |
10.7 |
||
5000 |
105.7 |
12.3 |
11.3 |
20.3 |
13.7 |
||
N-ethyl-N’-nitro-N-nitrosoguanidine |
607.3 |
207.7 |
- |
- |
- |
||
Positive |
4-nitro-O-phenylenediamine |
- |
- |
406.0 |
- |
- |
|
controls |
4-nitroquinoline N-oxide |
- |
- |
- |
191.3 |
- |
|
9-aminoacridine |
- |
- |
- |
- |
791.3 |
||
Experiment 2: With S9 mix |
|||||||
Concentration |
Number of revertants (colonies/plate) |
||||||
Treatment |
(microgram/plate) |
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||
0 |
128.7 |
15.7 |
21.3 |
23.3 |
13.0 |
||
312.5 |
129.0 |
17.0 |
21.3 |
24.3 |
12.3 |
||
Test |
625 |
121.3 |
16.7 |
22.3 |
18.7 |
13.0 |
|
substance |
1250 |
120.3 |
16.3 |
23.0 |
21.0 |
14.3 |
|
2500 |
117.7 |
19.3 |
22.3 |
24.0 |
12.7 |
||
5000 |
115.3 |
19.0 |
17.7 |
26.3 |
13.3 |
||
Positive |
Benzo(a)pyrene |
531.7 |
- |
291.0 |
445.3 |
133.3 |
|
controls |
2-aminoantracene |
- |
361.3 |
- |
- |
- |
|
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.