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EC number: 204-077-3 | CAS number: 115-27-5
- 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

Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 13 January 1978 to 3 February 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- information on temperature and humidity were not recorded. Food consumption was not monitored.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- EC Number:
- 204-077-3
- EC Name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- Cas Number:
- 115-27-5
- Molecular formula:
- C9H2Cl6O3
- IUPAC Name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- Details on test material:
- - Name of test material (as cited in study report): Chlorendic anhydride- Physical state: White somewhat chunky powder- Analytical purity: 93.81%- Lot/batch No.: 3-12-206
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sweetwater Farms, Hillsboro, Ohio
- Weight at study initiation: Male 2124 to 2781 g. Female 2187 to 2602 g
- Diet: Purina Rabbit Chow ad libitum
- Water: ad libitum
- Acclimation period: Approximately 2 weeks.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on exposure:
- TEST SITE
- Area of exposure: Dorsal
- % coverage: Approximately 10% of body surface
- Type of wrap if used: None
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100, 500 and 2500 mg/kg
VEHICLE
- Justification for use and choice of vehicle (if other than water): physiological saline used as control
- Amount(s) applied (volume or weight with unit): 1.2 ml/kg/day
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 5 days per week for 3 weeks for a total of 15 applications
- Frequency of treatment:
- Daily for 5 weekdays, break at week-ends for 3 weeks.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: All
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At termination of study
- Animals fasted: No data
- How many animals: All
URINALYSIS: Yes
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: No data
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: YesHISTOPATHOLOGY: Yes
- Statistics:
- All statistical analyses compared the treatment groups with the control group by sex. At termination of the study, body weights, hematologic, biochemical and urinalysis parameters and absolute and relative organ weights were compared by analysis of variance (one-way classification), Bartlett's test for homogeneity of variances and the appropriate t-test (for equal or unequal variances) as described by Steel and Torrie using Dunnett's multiple comparison tables to judge significance of differences.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Incidental findings (primarily at the 2500 mg/kg/day dosage level) included: diarrhea, nasal or ocular discharge, hypoactivity, anorexia and dehydration.
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- One or more signs of dermal irritation were present for all treated rabbits. The level of intensity and time of onset were primarily dose related. At the 100 mg/kg/day dosage level, a barely perceptible erythema was noted for all rabbits beginning in weeks 2 or 3 of treatment. At the 500 mg/kg/day dosage level, the onset of erythema (barely perceptible to slight) was usually evident by day 4 and persisted throughout most, or all or the treatment period. Other signs of dermal irritation (barely perceptible to slight) included: edema, atonia, desquamation, coriaceousness and fissuring. These signs were evident for most treated rabbits during either the second or third week of treatment. At the 2500 mg/kg/day dosage level, erythema (barely perceptible to moderate) was evident as early as day 2 and persisted throughout the study for most rabbits. Other signs of dermal irritation as noted previously (barely perceptible to moderate) were evident by, or on, day 7 and for most rabbits persisted throughout the treatment period.
- Mortality:
- no mortality observed
- Description (incidence):
- None of the rabbits died.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Female rabbits in the 2500 mg / kg / day group had decreased body weight gains when compared to controls. Males had slight but statistically significant weight losses.
- 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:
- no effects observed
- Description (incidence and severity):
- No changes considered to be related to compound were seen in the hematologic studies.
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No urine was collected from one male and one female rabbit in the 2500 mg kg day treatment group. All other urinalyses were similar to the control.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No compound related organ weight variations were observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Six rabbits from the 2500 mg/kg/day group and 2 rabbits from the 500 mg/kg/day group had stomach lesions which may have been compound related. These stomach changes were described as ulcerations, erosions and yellow gray or white foci or areas in the mucosa. They were not seen in rabbits from the control or 100 mg/kg/day groups.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Stomach erosions noted grossly and confirmed microscopically in several rabbits from the 2500 mg/kg/day group were shallow and did not extend the full thickness of the mucosa. The stomach mucosa away from the grossly noted erosions was completely normal. Erosions or other stomach alterations could not be confirmed microscopically in all stomachs in which a gross description of a lesion was made. Stomach lesions were not seen microscopically in rabbits from the control or 100 mg/kg/day groups; their occurrence in rabbits from the 500 and 2500 mg/kg/day groups was probably compound related.
Evidence of very slight to slight compound-related dermal irritation was seen in most rabbits from the 2500, 500 and 100 mg/kg/day groups. These skin changes included epidermal acanthosis and hyperkeratosis and inflammatory cell infiltrate in the dermis. The severity of these skin changes appeared somewhat dose related and the overall skin response to this compound could best be characterized as mild. Other microscopic lesions were considered spontaneous and unrelated to treatment and were typical of the usual lesions seen in untreated rabbits.
Brain lesions characterized by perivascular lymphocytic cuffing, glial nodules and lymphocytic meningitis were considered due to infestation by Encephalitozoan cunniculli, a common protozoan parasite of laboratory rabbits. - Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 2 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: observed effects were not considered as adverse and significant
Target system / organ toxicity
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- stomach
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Evidence of mild skin irritation, characterized by hyperkeratosis, acanthosis and dermal inflammatory cell infiltrate was seen at the application site in most rabbits from the 100, 500 and 2500 mg / kg / day groups and was considered compound related. Overall skin response based on microscopic examination of the application site was characterized as mild.
- Executive summary:
Chlorendic Anhydride was administered to the backs of New Zealand White rabbits at dosage levels of 100 500 and 2500 mg/kg/day 5 days a week during this 3 week dermal study according to a method similar to OECD Testing Guideline 410 (non GLP) with deviations. Four male and four female rabbits were used at each dosage level and in the control group. The rabbits were observed daily for signs of overt toxicity, general behavior, dermal irritation, moribundity or mortality. Body weights were recorded weekly Hematologic, biochemical and urinalysis studies were conducted during the control period and following the 2l day treatment period. One or more of the following signs of dermal irritation were noted for all treated rabbits: erythema, edema, atonia, desquamation coriaceousness and fissuring. The number of signs observed, severity of the conditions barely perceptible to moderate and duration were dose related. Incidental findings primarily at the 2500 mg/kg/day dosage level included diarrhea, nasal or ocular discharge, hypoactivity, anorexia and dehydration. Male and female rabbits at the high dosage level had decreases in weight when compared with the controls. All rabbits survived the treatment period. No changes considered related to compound were seen in the hematologic and biochemical studies. Urinalyses were considered normal. Stomach mucosal lesions described as erosions ulcerations or light foci and areas at necropsy in rabbits from the 2500 and 500 mg/kg/day were the only gross findings at terminal sacrifice which were considered compound related. No compound related organ weight variations were observed. Microscopically grossly described stomach changes were confirmed in several rabbits from the 500 and 2500 mg/kg/day groups. These changes were attributed to compound effect. Evidence of mild skin irritation characterized by hyperkeratosis, acanthosis and dermal inflammatory cell infiltrate was seen at the application site in most rabbits from the 100, 500 and 2500 mg/kg/day groups and was considered compound related. Overall skin response based on microscopic examination of the application site was characterized as mild.
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