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EC number: 203-931-2 | CAS number: 112-05-0
- 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
Carcinogenicity
Administrative data
Description of key information
No clearly treatment-related systemic effects were observed in a dermal carcinogenicity study (Celanese/Kettering, 1985, RL3). No information is available for other routes of exposure.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Start of exposure: 18 May 1981, treatment 80 weeks
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- dermal carcinogenicity study
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- C3H
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratory, Bar Harbour, Maine, USA
- Age at study initiation: 6-8 weeks
- Housing: 5 percage
- Diet (ad libitum): Rodent Laboratory Chow 5001 (Ralston Purina)
- Water (ad libitum): hyperchlorinated-acidified water
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3 +/- 1.1
- Humidity (%): 45 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: interscapular region
REMOVAL OF TEST SUBSTANCE: no
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg/animal per treatment
- Constant volume or concentration used: yes
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 80 wks
- Frequency of treatment:
- 2x/wk
- Post exposure period:
- Post-exposure recovery period: none
- Remarks:
- Doses / Concentrations:
50 mg/animal/treatment (undiluted)
Basis:
other: nominal, maximum tolerated dose - Remarks:
- Doses / Concentrations:
400 mg/kg bw/day
Basis:
other: dermal dose - No. of animals per sex per dose:
- 50 males
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: none
- Positive control:
- benzo(a)pyrene (50 mg/animal/treatment)
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily with approx. 8 h interval
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly during the first month of the study and every teo weeks thereafter
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Additionally to the skin of the interscapular area (test site), a complete macroscopic and microscopic examination of all internal organs was performed in all animals). - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- HISTOPATHOLOGY: NON-NEOPLASTIC
Result (carcinogenicity): negative
HISTOPATHOLOGY: NEOPLASTIC: negative
The positve control substance, benzo(a)pyrene, produced a high incidence of skin neoplasms. - Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: dose calculated (50 mg/treatment, twice weekly)
- Remarks on result:
- not determinable because of methodological limitations
- Conclusions:
- Under the conditions of this study the test item did not produce clearly treatment-related non-neoplastic or carcinogenic effects, apart from skin irritation. A slight increase in hepatocellular liver carcinomas in the group treated with the test substance might be produced by the exposure, but could also be a random error.
- Executive summary:
50 male C3H mice were dermally exposed to the test item (purity not stated) for 80 weeks (twice weekly, 50 mg per treatment, maximum tolerated dose based on a pre-test). Control groups of equal size received no treatment or were treated with the vehicle (mineral oil, used for other compounds in this study), respectively. The treatment did not reduce survival. Non-neoplastic skin effects were at least partially evoked by the repeated clipping during the exposure period. No skin tumours were observed. The positive control substance, benzo(a)pyrene, caused a high incidence of skin neoplasms. Compared to the control groups the test item produced no clearly treatment-related systemic non-carcinogenic or carcinogenic effects. The NOAEL of this study for carcinogenicity was approx. 400 mg/kg bw/day (Celanese/Kettering, 1985).
Reference
The test substance did not increase the incidence of skin tumors (0/48, compared to 1/50 in untreated animals and 0/48 in mineral oil-treated animals. The incidences of non-neoplastic or carcinogenic effects in internal organs are shown in the table below. No clearly treatment-related effects are obvious.
Non-neoplastic skin effects are presented in chapter 7.5.2.
Summary table of neoplastic and non-neoplastic organ changes
untreated (n = 49) |
mineral oil (n = 47) |
C-182 (nonanoic acid) (n = 48) |
|
Lung |
|||
pneumonia |
10 |
11 |
15 |
abscess |
4 |
1 |
1 |
fibrosis |
3 |
5 |
2 |
atelectasis |
6 |
3 |
3 |
edema/hemorrhage |
2 |
3 |
1 |
adenoma |
2 |
0 |
0 |
carcinoma |
0 |
0 |
1 |
metastasis |
3 (liver) |
1 (liver) |
0 |
Kidneys |
|||
chron. interstit. nephritis |
9 |
6 |
4 |
Spleen/lymph nodes |
|||
hemosiderin |
5 |
7 |
5 |
leukemia/lymphoma |
0 |
0 |
3 |
Liver |
|||
degeneration |
0 |
7 |
8 |
hepatocarcinoma |
18 |
11 |
23 |
Intestinal tract |
|||
gastritis/entero-colitis |
3 |
8 |
6 |
abscess |
4 |
4 |
0 |
Testes |
|||
atrophy |
2 |
3 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 400 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- sufficiently good. No adverse effect or target organ was identified in a dermal cancer study. Though the study is not considered to be reliable due to methodological deficiencies, the available information is considered to be sufficient because there is no structural alert, and no genetic toxicity was seen in appropriate studies.
Mode of Action Analysis / Human Relevance Framework
In the absence of information on a species specific effect the data are regarded as relvant for humans.
Justification for classification or non-classification
Based on the available data a classification according to Regulation (EC) No 1272/2008 is not required.
Additional information
50 male C3H mice were dermally exposed to the test item for 80 weeks (twice weekly, 50 mg per treatment, maximum tolerated dose based on a pre-test). Control groups of equal size received no treatment or were treated with the vehicle (mineral oil, used for other compounds in this study), respectively. The treatment did not reduce survival. Non-neoplastic skin effects were at least partially evoked by the repeated clipping during the exposure period. No skin tumours were observed. The positive control substance, benzo(a)pyrene, caused a high incidence of skin neoplasms. Compared to the control groups the test item produced no clearly treatment-related systemic non-carcinogenic or carcinogenic effects. The NOAEL of this study for carcinogenicity was approx. 400 mg/kg bw/day (Celanese/Kettering, 1985).
This study was not judged to be reliable with respect to carcinogenic effects (RL3) due to significant methodological deficiencies.
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.
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