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Diss Factsheets
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EC number: 288-284-4 | CAS number: 85711-26-8
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- group sizes are smaller than recommended, 10 pregnant females rather than 20; some omissions in reporting
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- (only 10 animals per group instead of the 20 indicated in guideline; some omissions in reporting)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C7-11-branched and linear
- EC Number:
- 287-623-3
- EC Name:
- Alcohols, C7-11-branched and linear
- IUPAC Name:
- Alcohols, C7-11-branched and linear
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Chbb/THOM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr K Thomae GmbH, Biberach, Germany
- Age at study initiation: 68-85 days (females)
- Weight at study initiation: 214-233 g (females)
- Fasting period before study: no data
- Housing: singly in stainless steel wire-mesh cages
- Diet (e.g. ad libitum): ground Kliba feed 343 rat/mouse/hamster, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data (air-conditioned)
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: double-distilled water with Cremophor EL as emulsifier
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: emulsified in double-distilled water containing 0.005% Cremophor EL. Prepared daily using a high-speed sonicator; a magnetic stirrer was used to keep the emulsion homogenous during dosing.
VEHICLE
- Justification for use and choice of vehicle (if other than water): to ensure even distribution of the test material
- Concentration in vehicle: 28.8, 144 or 288 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg bw/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations analysed by gas chromatography after homogenization by the addition of dioxane.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 male to 1-4 females
- Length of cohabitation: overnight
- Further matings after two unsuccessful attempts: no
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Any other deviations from standard protocol: no - Duration of treatment / exposure:
- days 6-15 post coitum
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 144 mg/kg bw/day
- Dose / conc.:
- 720 mg/kg bw/day
- Dose / conc.:
- 1 400 mg/kg bw/day
- No. of animals per sex per dose:
- 8-10 females
- Control animals:
- yes, concurrent vehicle
- other: double-distilled water
- Details on study design:
- - Dose selection rationale: based on equimolar dose levels as this was a study to compare toxicity of various C7-11 alcohols
- Rationale for animal assignment (if not random): random
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION: yes
WATER CONSUMPTION: no
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #20
- Organs examined: uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: live foetuses, dead foetuses, numbers of implantations were shown as: live foetuses, dead implantations, early resorptions (stained), early & late resorptions (unnstained), dead foetuses; conception rates and pre & post implantation losses were calculated. - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: yes: half per litter - Statistics:
- Dunnetts test for most reproductive parameters and Fishers exact test for evaluaton of conception rate and all foetal findings.
- Indices:
- no data
- Historical control data:
- none
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No maternal toxicity or deaths occurred. There were no differences in body weight gain between the treated and control groups on days 0, 6, 15 or 20 and no differences in food consumption was evident. No differences were seen in the uterus, placental and foetal weights and the number of corpora lutea, implantation sites and live foetuses per dam were similar between the groups.
- Number pregnant per dose level: water control 9, aqueous emulsifier control 10, 144 mg/kg bw/day 9, 720 mg/kg bw/day 10, 1440 mg/kg bw/day 8.
- Number aborting: None
- Number of resorptions: comparable in treated and control groups. Resorptions/dam (mean) 1.2, 1.1 (control groups) 1.0, 1.2 and 1.1 for low, mid and high dose groups respectively.
- Number of implantations: comparable in treated and control groups. Implantation sites/dam (mean) 15.0, 15.7 (control groups) 14.8, 15.8 and 13.9 for low, mid and high dose groups.
- Post implantation loss: comparable in treated and control groups.
- Number of corpora lutea: comparable in treated and control groups. Corpora lutea/dam (mean) 16.1, 16.0 (control groups) 17.0, 17.0 and 15.6 for low, mid and high dose groups respectively.
- Duration of Pregnancy: comparable in treated and control groups.
No haematology, clinical chemistry, macro- or microscopic examinations were carried out and organs were not weighed (other than the uterus).
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 440 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 440 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No embryotoxic effects were detected that were attributed to the treatment. Similar numbers of abnormalities occurred in the treated and control groups for the following parameters: bilateral renal pelvis, hydroureter, thoracic vertebral body dumbbell shaped, skeletal variations and skeletal retardations.
- Litter size and weights: comparable in treated and control groups. Foetal weights (mean) 3.8, 3.82 (controls) 3.88, 3.79 and 3.82 for low, mid and high dose groups respectively.
- Number viable: viability was comparable to controls. Live foetuses/dam (mean) 13.8, 14.6 (controls) 13.8, 14.6 and 12.8 for low, mid and high dose groups respectively.
- Sex ratio: Not reported.
- Total malformations, variations and retardations: the incidence was unaffected by treatment. Litters (%) with malformations (no. of litters) 11.1% (1), 20.0% (2)(controls) 11.1% (1), 40.0% (4) and 12.5% (1) for low, mid and high dose groups respectively.
- Litters (%) with variations (no. of litters) 88.9% (8), 100% (10) (controls) 100% (9), 100% (10) and 100% (8) for low, mid and high dose groups respectively.
- Litters (%) with retardations (no. of litters) 88.9% (8), 100% (10) (controls) 77.8% (7), 90.0% (9) and 87.5% (7) for low, mid and high dose groups respectively.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 440 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a reliable study, conducted to a protocol similar to OECD guideline 414, a mixture of mainly linear C7-9-11 alcohols exhibited no maternal or foetal toxicity after oral administration to rats on gestation days 6-15 at up to 1440 mg/kg bw/day. The study was performed to GLP.
- Executive summary:
C7-11-branched and linear alcohols was administered at daily gavage doses of 0, 140, 720 and 1440 mg/kg bw/day to pregnant rats. No maternal toxicty was observed, and no adverse effects were recorded on foetal and developmental parameters.
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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