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EC number: 201-029-3 | CAS number: 77-47-4
- 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
![](https://poisoncentres.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:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- The highest dose did not induce maternal toxicity. Exposure limited to the organogenesis period.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Hexachlorocyclopentadiene
- EC Number:
- 201-029-3
- EC Name:
- Hexachlorocyclopentadiene
- Cas Number:
- 77-47-4
- Molecular formula:
- C5Cl6
- IUPAC Name:
- hexachlorocyclopentadiene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: approximately 3 months old at the time of mating
- Weight at study initiation:
- Housing: Individually in wire mesh cages
- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: Two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): controlled
- Photoperiod (hrs dark / hrs light):
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg/day - Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/1
- Length of cohabitation: not specified
- Proof of pregnancy: vaginal plug or sperm in vaginal smear] referred to as day 0 of pregnancy - Duration of treatment / exposure:
- From Day 6 through Day 15 of gestation
- Frequency of treatment:
- Once a day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 3 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25 female animals / dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: on Days 0, 6, 9, 12, 16 and 20 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20 - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 2/3 per litter
- Head examinations: No data - Statistics:
- All statistical analyses compared the treatment groups with the control group, with a level of significance at p<0.05. Male to female fetal sex ratio, and number of litters with anomalies were compared using the Chi-square test criterion with Yates correction and/or Fisher's exact probability test, as described by Siegel, to judge significance of differences.
The percentage of early resorbed fetuses, and post implantation losses were compared by the Mann-Whitney U-test as described by Siegel and Weil to judge significance of differences.
Mean number of corpora lutea, total implantations, and viable fetuses were compared by analysis of variance, Bartlett's test for homogeneity of variances and the appropriate t-test as described by Steel and Torrie, using Dunnett's multiple comparison table, to judge significance of differences.
Fetal body weights were compared by analysis of variance and t-test, as described by Steel and Torrie, using Dunnett's multiple comparison table, to judge significance of differences.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no differences in appearance or behaviour in any of the rats attributable to treatment with Hexachlorocyclopentadiene at 3 or 10 mg/kg bw per day when compared to the rats in the control group. Staining of the anogenital area was seen in all treated groups, however, it was of longer duration in the rats in the 30 mg/kg bw dosage group.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- Survival was 100% for all groups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean maternal body weights were comparable for rats in the treated groups and the control group.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of implantation losses between the treated groups and the control group.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of resorptions between the treated groups and the control group.
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of resorptions between the treated groups and the control group.
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of dead foetuses between the treated groups and the control group.
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- not examined
- Details on maternal toxic effects:
- There were no biological meaningful differences in the mean number of implantations, corpora lutea, live foetuses, and post implantation losses between the treated groups and the control group. No maternal toxicity was observed.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- dead fetuses
- early or late resorptions
- maternal abnormalities
- mortality
- pre and post implantation loss
- total litter losses by resorption
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean foetal body weights between the treated groups and the control group.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of live foetuses between the treated groups and the control group.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the male to female sex ratio between the treated groups and the control group.
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of litters with malformations between the treated groups and the control group.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of litters with malformations between the treated groups and the control group.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- There were no biological meaningful differences in the mean number of litters with malformations between the treated groups and the control group.
- Details on embryotoxic / teratogenic effects:
- There were no biological meaningful differences in the mean number of live foetuses, mean foetal body weights, male to female sex ratio and the number of litters with malformations between the treated groups and the control group.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No signs of maternal or developmental toxicity was observed at up to 30 mg/kg bw/day.
- Executive summary:
The developmental toxicity / teratogenicity of Hexachlorocyclopentadiene was evaluated during a study performed according to a method similar to the OECD Testing Guideline 414 (non-GLP).
The substance was administrated by gavage to CD rats at dosage levels of 3, 10 and 30 mg/kg bw/day from Day 6 through 15 of gestation. A control group received the vehicle - corn oil - at 10 ml/kg bw/day. During gestation the females were observed for clinical signs, mortality and changes in body weight. Cesarean sections were performed on Day 20 of gestation. The numbers of viable and non-viable fetuses, early and late resorptions, corpora lutea and total implantations were recorded. The fetuses were weighted and sexed. Examinations for external, soft tissue and skeletal anomalies and variations were performed.
There were no differences in appearance or behaviour in any of the rats attributable to treatment with Hexachlorocyclopentadiene at 3 or 10 mg/kg bw per day when compared to the rats in the control group. Staining of the anogenital area was seen in all treated groups, however, it was of longer duration in the rats in the 30 mg/kg bw dosage group. Survival was 100% for all groups. Mean maternal body weights were comparable for rats in the treated groups and the control group. There were no biological meaningful differences in the mean number of implantations, corpora lutea, live foetuses, post implantations losses, mean foetal body weights, male to female sex ratio and the number of litters with malformations between the treated groups and the control group. Developmental variations were comparable for the treated groups and the control group.
A NOAEL above 30 mg/kg bw/day can be derived for both maternal toxicity and developmental toxicity.
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