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EC number: 218-489-6 | CAS number: 2162-98-3
- 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
Acute Toxicity: oral
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Study Plan, Preparation of the Test item, p. 10 deviation did not influence the quality or integrity of the present study
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,10-dichlorodecane
- EC Number:
- 218-489-6
- EC Name:
- 1,10-dichlorodecane
- Cas Number:
- 2162-98-3
- Molecular formula:
- C10H20Cl2
- IUPAC Name:
- 1,10-dichlorodecane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: WISTAR rats Crl: WI(Han)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female (non-pregnant and nulliparous)
Number of animals: 3 per step / 2 steps performed
Age at the
beginning of the study: 8-10 weeks
Body weight on the
day of administration: Step 1, animals no.: 1-3: 146 – 173g
Step 2, animals no.: 4-6: 165 – 172g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare [9] the animals were bred for experimental purposes.
This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.
- Full barrier in an air-conditioned room
- Temperature: 22 3 °C
- Relative humidity: 55 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Sex: female (non-pregnant and nulliparous)
Number of animals: 3 per step / 2 steps performed
The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required. - Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no animal died
- Clinical signs:
- other: The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection, hunched posture, moving the bedding and half eyelid-closure. All symptoms recovered within up to 1 da
- Gross pathology:
- At necropsy, no macroscopic findings were observed in any animal of any step.
Any other information on results incl. tables
Step |
Animal No. / Sex |
Starting Dose (mg/kg bw) |
Time Point |
Observations |
|||||
1 |
1 / Female |
2000 |
0 – 120 min |
nsf |
|||||
120 – 180 min |
Slightly reduced spontaneous activity, hunched posture, moderate piloerection, |
||||||||
180 min – d 2 |
Slightly reduced spontaneous activity, slight piloerection, |
||||||||
d 2 – d 15 |
nsf |
||||||||
2 / Female |
0 – 120 min |
nsf |
|||||||
120 min – d 2 |
Slightly reduced spontaneous activity, slight piloerection, |
||||||||
d 2 – d 15 |
nsf |
||||||||
3 / Female |
0 – 120 min |
nsf |
|||||||
120 min – d 2 |
Slightly reduced spontaneous activity, slight piloerection, |
||||||||
d 2 – d 15 |
nsf |
Step |
Animal No. / Sex |
Starting Dose (mg/kg bw) |
Time Point |
Observations |
2 |
4 / Female |
2000 |
0 – 60 min |
Slightly reduced spontaneous activity, hunched posture, slight piloerection |
60 – 120 min |
Moderately reduced spontaneous activity, hunched posture, moderate piloerection, prone position, moving the bedding |
|||
120 – 180 min |
Slightly reduced spontaneous activity, hunched posture, moderate piloerection |
|||
180 min – d 2 |
Slightly reduced spontaneous activity, hunched posture, slight piloerection |
|||
d 2 – d 15 |
nsf |
|||
5 / Female |
0 – 60 min |
Slightly reduced spontaneous activity, hunched posture, slight piloerection |
||
60 – 180 min |
Slightly reduced spontaneous activity, hunched posture, moderate piloerection |
|||
180 min – d 2 |
Slightly reduced spontaneous activity, hunched posture, slight piloerection |
|||
d 2 – d 15 |
nsf |
|||
6 / Female |
0 – 60 min |
Slightly reduced spontaneous activity, hunched posture, slight piloerection |
||
60 – 180 min |
Slightly reduced spontaneous activity, hunched posture, moderate piloerection |
|||
180 min – d 2 |
Slightly reduced spontaneous activity, hunched posture, slight piloerection |
|||
d 2 – d 15 |
nsf |
Step |
Animal No. / Sex |
Starting Dose |
BW (g) |
Body Weight Change in Comparison to Day 1 (%) |
|||||||||
Day 1 |
Day 8 |
Day 15 |
Day 15 |
||||||||||
1 |
1 / Female |
2000 |
173 |
193 |
210 |
21 |
|||||||
2 / Female |
146 |
168 |
180 |
23 |
|||||||||
3 / Female |
173 |
198 |
212 |
23 |
|||||||||
2 |
4 / Female |
168 |
191 |
205 |
22 |
||||||||
5 / Female |
165 |
186 |
195 |
18 |
|||||||||
6 / Female |
172 |
212 |
214 |
24 |
Step |
Animal No. / Sex |
Starting Dose (mg/kg bw) |
Organ |
Macroscopic Findings |
|||||
1 |
1 / Female |
2000 |
- |
nsf |
|||||
2 / Female |
- |
nsf |
|||||||
3 / Female |
- |
nsf |
|||||||
2 |
4 / Female |
- |
nsf |
||||||
5 / Female |
- |
nsf |
|||||||
6 / Female |
- |
nsf |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item 1,10-Dichlorodecane to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not mortality. The median lethal dose of 1,10-Dichlorodecane after a single oral administration to female rats, observed over a period of 14 days is: LD50 (rat) > 2000 mg/kg bw.
- Executive summary:
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was emulsified with the vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg. All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.
Table1: Resultsper Step
Step
Sex / No.
Starting Dose (mg/kg bw)
Number of Animals
Number of Intercurrent Deaths
1
Female / 1 - 3
2000
3
0
2
Female / 4 - 6
2000
3
0
bw = body weight
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection, hunched posture, moving the bedding and half eyelid-closure. All symptoms recovered within up to 1 day post-dose. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step.
LD50(rat): > 2000 mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle: corn oil
Number of animals: 3 per step / 2 steps performed
Method: OECD 423[4]
EC 440/2008, Method B.1 tris[5] OPPTS 870.1100[6]
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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