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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- 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: reliable study report, no guideline available For justification of read-across please refer to section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The test material was applied dermally to the clipped skin of rats daily for a period of 14 days, 5 days/week. During this period and after the last application, skin reactions as signs of irritancy were recorded according to the Draize scale.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc., Indianapolis, IN, USA
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: 206.2-234.1 g
- Housing: 6/group
Administration / exposure
- Type of coverage:
- other: The treatment area was uncovered following the first 6 applications and covered following the last 4 applications.
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: dorsal area from the scapular region to just above the rump, approx. 5 cm wide
TEST MATERIAL
- Amount applied: 2.0 mL per kg body weight
- Concentration: 0, 0.03/0.6, 0.1, 0.3, 1.0 and 3.0 % (irritation was not observed during the first week of the study, animals which received a 0.03 % solution of test substance for the first five applications received a 0.6 % solution of test substance for the last five applications)
- Constant volume or concentration used: yes
DURATIN OF EXPOSURE
- Two weeks (10 applications), with the exception of the high-dose (3.0%) animals which were only dosed for 5 days due to severe skin irritation. - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 10 applications except for the highest dose group: 5 applications, 6 hours/day
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.03/0.6, 0.1, 0.3, 1.0 and 3.0 % (animals which received a 0.03% solution of test substance for the first five applications received a 0.6% solution of test substance for the last five applications)
Basis:
other: active substance
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control:
- not required
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
DERMAL IRRITATION: Yes
- Time schedule for examinations: The skin of the application site was evaluated for erythema and edema six hours after the 5th application, prior to the 6th application, six hours after the 10th application, and prior to sacrifice. - Sacrifice and pathology:
- HISTOPATHOLOGY: The skin at the application site was collected and fixed for possible future histopathological examination.
- Other examinations:
- not applicable
- Statistics:
- not applicable
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- not examined
- 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
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality occured. Perinasal and periocular encrustation were observed in all high-dose (3.0%) animals during the first week of the study and in one animal at the 0.1% level on Day 12. Hyperactivity lasting several minutes was observed in animals in the 1.0% treatment group immediately following dose application on Day 8.
DERMAL IRRITATION
Erythema and edema were found from the 1 % dose group onwards. No erythema or edema were present in the lower dose groups.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 6 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: local skin effects after 2 week application calculated from the concentration of 0.3 % a.s. in water at 2 mL/kg bw/day (3 mg/mL x 2 mL/kg bw/day = 6 mg/kg bw/d) corresponding to 0.045 mg/cm2
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
It was assumed that the treated body surface was 10 %. The total surface body of rat (male and female) is 400 cm2 and the mean body weight is 300 g. Assuming that 10 % of the body surface has been exposed to the test substance, the resulting exposed area is of 40 cm2.
The NOAEC in mg/cm2 was calculated according to the following formula:
NOAEC in mg /cm2 =( Total dose applied in mg)/( Treated surface in cm2) =
(average animal weight in kg * dose in mg kg bw)/ (treated surface area in cm2)
NOAEC = (0.3 kg x 6 mg/kg bw/day) / 40cm2 = 0.045 mg/cm2
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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