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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 230-029-6 | CAS number: 6920-22-5
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from January 18,2006 to May 10, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline test following GLP regulations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- DL-hexane-1,2-diol
- EC Number:
- 230-029-6
- EC Name:
- DL-hexane-1,2-diol
- Cas Number:
- 6920-22-5
- Molecular formula:
- C6H14O2
- IUPAC Name:
- hexane-1,2-diol
- Test material form:
- other: clear colorless liquid
- Details on test material:
- CAS No.: 6920-22-5
EC No.: 230-029-6
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on test animals or test system and environmental conditions:
- Animals and Animal Husbandly:
A total of ninety-six time-mated female Crl:CD (SD) IGS BR strain rats were obtained from Charles River (UK) Limited, Margate, Kent. Animals were delivered in two batches of forty-eight animals two days apart; each delivery batch contained twenty-four animals at Day 1 of gestation and twenty-four animals at Day 0 of gestation. All females were supplied with stud male identification records and were identified using the supplier’s standard identification methods.
Throughout the study the animals were given pelleted diet (Certified Rodent diet PMI 5002 supplied by BCM IPS Ltd., London UK) and water was supplied via bottles attached to each cage, ad libitum. The diet and water were considered not to have contained any contaminants at a level which may have affected the outcome of this study.
Upon arrival the females were temporarily housed in groups of four or five in polypropylene cages with stainless steel grid floors and tops. Animals were then weighed and allocated to the study. Following allocation the females were caged individually in polypropylene cages with solid floors and stainless steel grid tops. Softwood chips were used as bedding material.
The animals were housed in a single air-conditioned room, providing at least fifteen air changes per hour. The room was maintained to operate within a temperature range of 19 and 23 °C and a relative humidity of 40 and 70% with these conditions monitored on a daily basis. The lighting within the room was controlled to allow twelve hours of continuous light within a twenty-four hour period.
Allocation:
On the day of arrival the females were assigned to treatment groups using a randomisation procedure based on stratified bodyweight to ensure, as far as possible, similar group mean bodyweights for each treatment group. The females were assigned to positions on the cage battery using a randomised block design.
At allocation females were given a unique earmark for the study according to the assigned number for each dose group. Each cage was identified with a colour coded cage card containing information including project number, dose group and animal number.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Experimental Preparation
The test material was prepared weekly as a solution in distilled water (vehicle) by weighing an appropriate amount of test material into a suitable container and adding sufficient vehicle to make the required volume. The test material formulations were shaken until all the test material dissolved. Formulations were therefore prepared weekly and stored at approximately +4 °C in the dark.
Dosing
Animals were dosed with the appropriate concentration of dose formulation once daily, using a metal catheter and syringe between Days 5 and 19 of gestation. Control females received vehicle only. The dose administered was adjusted for most recent bodyweight using a constant dose volume of 5 ml/kg bodyweight. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability and homogeneity of the test material formulations were determined by Safepharm Analytical Laboratory. Results showed the formulations to be stable for at least fourteen days.
- Details on mating procedure:
- The day that positive evidence of mating was observed was designated Day 0 of gestation.
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- once daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (control), 30, 100, 300 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Selection of Dose Levels
Dose levels of 300, 100 and 30 mg/kg/day were selected for use on this study based on results of a preliminary oral gavage prenatal developmental toxicity study in the rat (SPL Project Number 2082/0014). In this preliminary study, a dose level of 500 mg/kg/day was associated with adverse clinical signs that excluded this dosage level from use in this main investigation. A high dosage of 300 mg/kg/day was therefore chosen in anticipation of a degree of toxicity that would not impair the assessment of embryofoetal development. Lower dosages represent approximately three-fold reductions from this high dosage
Examinations
- Maternal examinations:
- 1. Morbidity/Mortality
All females were checked twice daily during the normal working week and once daily at weekends.
2. Clinical Observations
All females were observed once daily, in the morning throughout gestation and, additionally, one hour after dosing, throughout the dosing period, for clinical signs of toxicity.
3. Bodyweight
All females were weighed on Days 3, 5, 6, 7, 8, 11, 14, 17 and 20 of gestation.
4. Food Consumption
Food consumption for individual animals was recorded for discrete periods throughout the study on Day 3 to 5 Day 5 to 8 Day 8 to 11 (or 9 to 11) Day 11 to 14, Day 14 to 17 and Day 17 to 20 of gestation. - Ovaries and uterine content:
- Females were killed on Day 20 of gestation by carbon dioxide asphyxiation followed by cervical dislocation. Each animal was examined externally and internally for macroscopic abnormalities. The ovaries and uteri of pregnant females were removed, examined and the following data recorded;
i) Pregnancy status
ii) Number of corpora lutea
iii) Gravid Uterus weight
iv) Number, position and type of intra-uterine implantation
Implantation types were divided into:
Early Death: No visible distinction between placental/decidual tissue and embryonic tissue.
Late Death: Separate embryonic/foetal and placental tissue visible.
Dead Foetus: A foetus that had died shortly before necropsy. These were included as late deaths for reporting purposes. - Fetal examinations:
- The foetuses were killed by subcutaneous injection of sodium pentobarbitone. Except where conditions dictate otherwise, alternative foetuses were identified using an indelible marker and placed in Bouin’s fixative. These foetuses were transferred to 90% industrial methylated spirits (IMS) in distilled water and examined for visceral anomalies under a low power binocular microscope. The remaining foetuses were identified using colour coded wires and placed in 70% IMS in distilled water. The foetuses were eviscerated, processed and the skeletons stained with alizarin red. The foetuses were examined for skeletal development and anomalies.
All implantations and viable foetus were numbered according to their intra-uterine position as follows (V = viable foetuses):
Left Horn Cervix Right Horn
L1 L2 L3 L4 L5 L6 L7 L8 R1 R2 R3 R4 R5 R6 R7 R8
VI V2 V3 V4 V5 V6 V7 V8 V9 V10 Vll V12 V13 V14 V15 V16
v) Foetal sex
vi) External foetal appearance
vii) Foetal weight
viii) Placental weight - Statistics:
- Data were processed to give litter mean values, group mean values and standard deviations (where appropriate). The litter was regarded as the standard unit of assessment therefore values were first calculated within each litter and group mean values were calculated as the mean of these litter values.
The following parameters were analysed statistically, where appropriate, using the test methods outlined below:
Bodyweight, bodyweight change and food consumption: Bartlett’s test for homogeneity of variance and one way analysis of variance, followed by Dunnet’s multiple comparison test or, if unequal variances were observed, on alternative multiple comparison test.
Litter data and litter, placental and foetal weights: Kruskal-Wallis non-parametric analysis of variance; and a subsequent pairwise analysis of control value against treated values. - Indices:
- Percentage pre-implantation loss was calculated as:
(Number of corpora lutea - number of implantations)/ number of corpora lutea
Percentage post-implantation loss was calculated as:
(Number of implantations - number of live foetuses)/ number of implantations - Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
1 Clinical Observations and Mortality
There were no clinical signs associated with treatment and all females survived to scheduled termination on Day 20 of gestation.
2 Bodyweight
No adverse effects of treatment on bodyweight or bodyweight gain were apparent throughout the study at 300, 100 or 30 mg/kg/day
3 Food Consumption
No adverse effects of treatment on food consumption were apparent throughout the study at 300, 100 or 30 mg/kg/day,
4 Necropsy
All animals were pregnant and no macroscopic abnormalities were observed at macroscopic post mortem examination on Day 20 of gestation.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Litter Data and Litter Placental and Foetal Weights
There was no obvious adverse effect of maternal treatment on in-utero offspring survival, as assessed by the mean numbers of early or late resorptions, live litter size and post-implantation loss at 300, 100 or 30 mg/kg/day. Sex ratio was essentially similar in all groups and did not indicate any selective effect on survival for either sex.
Intergroup differences in mean litter, placental and foetal weights did not indicate any obvious effect on embryofoetal growth at these dosages.
2. Foetal examination
Neither the type, distribution nor incidence of foetal findings observed during external examination at necropsy or subsequent detailed visceral and skeletal examinations indicated any adverse effect of maternal treatment on foetal growth or development at 300, 100 or 30 mg/kg/day.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results given in this study, test article caused no adverse effect on the pregnant rat on the developing conceptus at dose levels up to 300 mg/kg. The ‘no-observed adverse effect level’(NOAEL) was therefore considered to be 300 mg/kg/day.
- Executive summary:
This study was conducted following OECD guideline 414 and GLP regulations to investigate the effects of test article on the embryotoxic/teratogenic development of rat. A total of 96 time-mated female Crl:CD(SD) IGS BR strain rats were administered orally, once daily, by gavage, at dose levels of 0, 30, 100 and 300 mg/kg/day. Clinical signs, bodyweights and food consumption were recorded during the study. The females were killed on Day 20 of gestation and subjected to macroscopic necropsy including examination of the uterine contents. The number of corpora lutea, number, position and type of implantation, placental weights, foetal weight, sex and external and internal macroscopic appearance were recorded. Treatment at dosage up to 300 mg/kg/day was well tolerated by the pregnant females and was not associated with any effects on clinical condition, bodyweight change, food intake or necropsy observations. There were no effects at dosages up to 300 mg/kg/day on embryofoetal survival, growth and development.
The 'No- observed-adverse-effect-level' (NOAEL) for the pregnant female and for embryofoetal survival, growth and development was therefore considered to be 300 mg/kg/day.
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.