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EC number: 413-390-6 | CAS number: 149144-85-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test guideline (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, near guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Purity: 99.2% w/w
Batch number: Y02259/003/001
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Specific Pathogen Free (SPF) colony at the Alderley Park Breeding Unit, ICI
- Age at study initiation: 28 days
- Weight at study initiation: (P) Males: 72.5 g; Females: 71.1 g
- Housing: 2 females or 1 male per cage
- Diet (e.g. ad libitum): CTI diet supplied by Special Diets Servies Limited
- Water (e.g. ad libitum): filtered tap water
- Acclimatisation period: 6-7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 45-60
- Air changes (per hr): 15 - 25
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 3-4 August 1987 To: 12 January 1988
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: hexane
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food):
Dose level 300 ppm: 9.07g/30 kg
Dose level 1800 ppm: 54.44g/30 kg
Dose level 12000 ppm: 362.90g/30 kg - Details on mating procedure:
- - M/F ratio per cage: 1 male and 2 female per cage
- Length of cohabitation: 10 days
- Proof of pregnancy: vaginal smear were examined daily
- After 10 days of unsuccessful pairing replacement of first male by another male with proven fertility
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): separately - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Mean concentrations within 2% of target concentration for all groups. DEHA was not detected in any control diet (detection limit 10ppm). Chemical stability of DEHA in diet was determined on three batches of diet at nominally 300 ppm and 12000 ppm. Satisfactory chemical stability was established.
Homogeneity of DEHA in diet mixtures was satisfactorily demonstraded on the first diet batch at nominally 300 and 12000 ppm DEHA. - Duration of treatment / exposure:
- 10 weeks
- Frequency of treatment:
- The rats in each generation were fed experimental diets continuously until termination.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 300, 1800, 12000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 28, 170, 1080 mg/kg
Basis:
nominal in diet
- No. of animals per sex per dose:
- 30 females and 15 males per group in total 4 groups.
- Control animals:
- yes, plain diet
- Details on study design:
- According to randomisation the rats where housed
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes, at least once daily
DETAILED CLINICAL OBSERVATIONS: Yes, once weekly
BODY WEIGHT: Yes, of all rats were recored at weekly intervals throughout the premating period.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, each cage of rats was recorded throughout the premating periods and calculated on a weekly basis. The food utilisation value per cage was calculated as the weight gained by the animals in the cage per 100g of food eaten.
- Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- STANDARDISATION OF LITTERS
A count of all live and dead pups was made within 24 hrs (day 1), at days 5, 11, 22, 29 and 36 post partum. The sexes of the pups were also recorded at these times.
- Postmortem examinations (parental animals):
- SACRIFICE
All animals at scheduled kills and those killed during the study were anaesthetised by inhalation of halothane BP vapour and killed by exsanguination. All surviving males were killed after completion of mating. All females were killed after weaning thier litters.
Histological examination: Cervix, Epididymis, Liver, Mammary gland, Ovary, Prostate, Seminal vesicle, Testis, Uterus, Abnormal tissues. - Postmortem examinations (offspring):
- All pups were killed as soon as possible after Day 36 post partum.
Histological examination: Cervix, Epididymis, Liver, Mammary gland, Ovary, Prostate, Seminal vesicle, Testis, Uterus, Abnormal tissues. - Statistics:
- Mean bodyweight gain, food consumption and food utilisation during the premating period, female bodyweight gain during pregnancy, parental liver weights and pup (litter) bodyweight gain until Day 36 post partum.
- Reproductive indices:
- Mean lenght of gestation, mean pre-coital interval
- Offspring viability indices:
- Mean live born index, mean survival index, mean litter size, total litter weight and whole litter losses.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
There was a slight increase in food consumption in males dosed with 12000ppm DEHA from 6-10 weeks of the study, the effect being statistically significant at weeks 6-9. Food utilisation was slifghtly less efficients overall for males receiving 12000ppm DEHA.
ORGAN WEIGHTS
An increase in liver weight was observed for both male and female parents receiving 12000ppm DEHA. No other groupp treatment group was effected. This increase in liver weight has been reported previously and is associated with peroxisome proliferation (Moody and Reddy 1978).
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1 080 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: increased absolute liver weights, and reduced body weight gain in females
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 170 mg/kg bw/day (nominal)
- Sex:
- male/female
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
Mean pup weight gain and total litter weight for both male and female offspring receiving 12000ppm DEHA were reduced throughout the whole of the post partum phase. There was no effect on either male or female pup weight gain in any other dose group in comparison with the control animals.
Effect levels (F1)
open allclose all
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 1 080 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 170 mg/kg bw/day (nominal)
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
The adminstration of 12000 ppm (approximately 1080 mg/kg/d) of the read-across substance DEHA in diet led to a reduction in female parent bodyweight gain during pregnancy and a reduction in offspring weight gain and litter size. No other reproductive parameters were affected and, in particular, there where no effects on fertility in either sex. Also were seen increased liver weights at 12000 ppm (approximately 1080 mg/kg/d) in male and female parents. The NOAEL for this study is ca. 170 mg/kg bw/d.
It is important additionally to note that for the structure "2 -Ethylhexyl" Reproctiontoxicity is one of the most sensitive endpoints and that these effects are considered as unlikely for the Bis(C12 -C13)alkyl-2 -hydroxybutandioate. Therefore to mention this study and to take these results is "worst case".
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