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EC number: 936-609-1 | CAS number: -
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment. No purity of test substance was given. Only 1 animal per sex was used per treatment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
- Principles of method if other than guideline:
- Albino rabbits were divided into 3 groups, namely 2 test groups (10, 50 mg/kg bw) and 1 control group (1 ml/kg bw dimethyl phthalate). Per dose 1 male and 1 female rabbit was treated each on intact and abraded skin (in summary 2 males and 2 females per dose). In the control group number of animals was doubled. The test substance was applied in dimethyl phthalate. Applications were administered five consecutive days per week for three weeks. The material was permitted to remain in contact with the animals' skins for six hours per day, the backs being wiped at the end of each daily exposure. Fifteen exposures were made. Control animals were handled in a manner similar to the test animals.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Irgacet Brown 2GL
- IUPAC Name:
- Irgacet Brown 2GL
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Acclimation period: 2 weeks
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: dimethyl phthalate
- Details on exposure:
- The backs of the animals were wiped after each daily exposure.
- Duration of treatment / exposure:
- 6 hours
- Frequency of treatment:
- five days a week, for a total of 3 weeks (15 exposures)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 50 mg/kg bw
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- Intact skin:
Group 1 (10 mg/kg bw): 1 female and 1 male rabbit
Group 2 (50 mg/kg bw): 1 female and 1 male rabbit
Control group (1 mL dimethyl phthalate/kg bw): 2 female and 2 male rabbits
Abraded skin:
Group 1 (10 mg/kg bw): 1 female and 1 male rabbit
Group 2 (50 mg/kg bw): 1 female and 1 male rabbit
Control group (1 mL dimethyl phthalate/kg bw): 2 female and 2 male rabbits - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- OBSERVATIONS: Comparison of general appearance and behaviour was reported without details.
DERMAL IRRITATION: Yes, at least after termination of study.
BODY WEIGHT: Yes
- Time schedule for examinations: Twice weekly, during the exposure period
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Prior to study and at termination of study
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: All study animals
- Parameters checked: Hb, RBC, WBC (differential count)
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Examined organs and tissues: Brain, Thyroid, Adrenal, Lung, Heart, Spleen, Bone Marrow, Stomach, Intestines, Pancreas, Liver, Kidney, Testes, Skeletal Muscle, Skin
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
No mortality occured. In all respects the treated groups behaved in a manner similar to the controls based upon gross observation.
HAEMATOLOGY:
Hematological findings in the experimental animals did not differ significantly from those of the control animals. All were within normal limits for the species.
ORGAN WEIGHTS:
No pattern of response attributable to the dosages applied was evident. Neither the sex of the animals, nor the condition of the skin at application (abraded or intact) appeared to have any significant effect upon the experimental animals' weight changes as compared to those of the control animals.
GROSS and HISTOPATHOLOGY:
There was no gross or histologic evidence of specific organ injury in any of the treated animals as compared to the controls which could be attributed to effect of the material under study. The skins at the site of drug application revealed no evidence of inflammation. A low incidence of those incidental and parasitic diseases often found in experimental rabbits was observed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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