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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-011-4 | CAS number: 505-52-2
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Combined Repeat Dose and Reproductive /Developmental Toxicity Screening Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Gudeline conform GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dodecanedioic acid
- EC Number:
- 211-746-3
- EC Name:
- Dodecanedioic acid
- Cas Number:
- 693-23-2
- Molecular formula:
- C12H22O4
- IUPAC Name:
- dodecanedioic acid
- Test material form:
- not specified
- Details on test material:
- Dodecanedioic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River LAboratories, Kingston, New York, USA
- Age at study initiation: (P) 10 wks;
- Weight at study initiation: (P) Males: 204.6 -230.7 g; Females: 166.5 - 195.9 g;
- Fasting period before study: no
- Housing: individually during pretest, premating, gestation; as breeding pais and as litters during lactation
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): adlibitum
- Acclimation period: 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2 °C
- Humidity (%):50 +/- 10%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 07.01.1992 To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous methyl cellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: daily
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 10, 50, 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw - Details on mating procedure:
- After 15 dosing days
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical determination demonstrated that dosing formulations contained the desired concentration of test item (85-101%).
Also stability at room temperature for the duration of the daily dosing period was shown. - Duration of treatment / exposure:
- 15 days until mating
throughout gestation and lactation - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100; 500; 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly during premating, gestation days 0; 7; 14; 18; 21 and lactation days 0 and 4
FOOD CONSUMPTION weekly during premating and mating, gestation days 0; 7; 14 and lactation days 0 and 4
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: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: Yes / No / No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of the study for all males (26.2.1992)
- Anaesthetic used for blood collection: Yes (CO2)
- Animals fasted: Yes
- How many animals: All males
- Parameters checked : erythrocyte, leukocyte, differentual laukocyte, platelet counts, hemoglobin, hematocrit, mean corpuscular hemoglobin, mean corposcular volume,
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of the study for all males (26.2.1992)
- Anaesthetic used for blood collection: Yes (CO2)
- Animals fasted: Yes
- How many animals: All males
- Parameters checked : alkaline phosphatase, alanine aminotransferase, asparttate aminotranferase activities, concentrations of blood urea nitrogen, total serum protein, albumin, globulin, creatine, total bilirubin, cholesterol, triglycerides, glucose, calcium, sodium, potassium, phosphate, chloride.
URINALYSIS: No - Statistics:
- One way analysis of variance followed by Dunnets's test. Bartlett's test for homogeneity of variances was performed on the oragn weight and clinicla laboratory data
- Reproductive indices:
- Mating Index, Fertility index, Gestation index, Pups born alive, Viability index, Litter survival
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Males. Decreased lymphocyte counts at 500 and 1000 mg/kg bw/d, no morphological correlate in spleen or thymus.
Clinical Chemistry
No effects.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
NOAEL (Repro/Developmental) = 1000 mg/kg bw/day.
Overall NOAEL = 1000 mg/kg bw/day
Compound related effects were limited to mild decreases in leukocyte(lymphocyte) counts.
Concentration (mg/kg bw/day) |
0 |
100 |
500 |
1000 |
No of Corpora lutea |
19.6 |
18.0 |
19.6 |
20.2 |
No of Implantations |
17.2 |
17.5 |
18.5 |
16.8 |
Total No of resorptions |
not reported |
not reported |
not reported |
not reported |
Total No of Fetuses |
15.2 |
15.6 |
16.4 |
15.5 |
Total No of live fetuses |
15.2 |
14.6 |
16.2 |
15.5 |
Mean fetal weight (g) |
6.7 |
6.6 |
6.5 |
6.5 |
Sex ratio (male/female) |
0.51 |
0.51 |
0.48 |
0.47 |
Applicant's summary and conclusion
- Conclusions:
- There were no adverse effects on reproduction and no adverse effect on parental animals or offspring.
NOAEL was 1000 mg/kg bw/day. - Executive summary:
A combined repeated dose toxicity Study with a Reproduction/Developmental Toxicity Screening Test was conducted following the OECD guideline 422, which was only published shortly after this study was performed. Goups of each 12 male and female rats received 0, 100, 500 or 1000 mg/kg bw/day of Dodecanedioic acid by gavage. After 14 days of dosing rats were mated within the treatment groups and allowed to produce litters. Dosing continued through mating, gestation and laction until day 54.
On day 0 and 4 postpartum, pups in each litter were counted, weighed collectively by sex and exmined for abnormal behaviour or appearance.Blood samples were collected from the male rats at the end of the study for hematological and clinical chemistry measurements.Parental animals were sacrificed for gross pathological examination. Selected organ weights were determined and control and high dose groups were subjected to histopathological examination.
Apart fom transient incidences of hyperactivity at high dose levels there were no clinicla signs. There were no mortalities, body weights, food consumption were not affected. Reproductive performance was not affected by treatment. Pups showed no adverse effects of treatment. No adverse effects were noted upon gross or histopathological examination or biochemistry of blood samples of parental rats.
A decrease in total leukocyte counts in samples of the high dose group had no morphological correlate in thymus or spleen.
Overall the NOAEL was observed at 1000 mg/kg bw/d the highest dose level, for both repeated dose toxicity and reproductive toxicity.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)