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EC number: 944-232-9 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In vivo study in rats. At the end of the observation period, the acute oral median lethal dose (LD50) of the test material was calculated.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young albino rats derived from Sprague-Dawley stock were used as test animals. All animals were kept under observation for five days prior to experimental use, during which period they were checked for general health and suitability as test animals. The animals were housed in stock cages and were permitted a standard laboratory diet plus water ad libitum, except during the 16-hour period immediately prior to oral intubation when food was withheld.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- 1350, 4556, 15380 mg/kg
- No. of animals per sex per dose:
- 4 animals per group (2 male/2 female) - total of 12 animals
- Control animals:
- no
- Details on study design:
- Initial screening was conducted in order to determine the general level of toxicity of the test material. Selected groups of albino rats were administered the test material at several dose levels. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.After oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages and observed for the following 14 days. Initial and final body weights, mortalities, and reactions were recorded. A necropsy examination was conducted on all animals.
- Statistics:
- At the end of the observation period, the acute oral median lethal dose (LD50) of the test material was calculated, if possible, using the techniques of Weil, Thompson, and Thompson and Weil.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 380 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: No pharmacotoxic symptoms were exhibited by the rats dosed at 1,350 and 4,556 mg/kg following oral administration of CIBANONE Olive S Paste. In rats dosed at 15,380 mg/kg hypoactivity was observed at 1 hour, ruffed fur at 3 hours, and black faeces at 5 ho
- Gross pathology:
- Necropsy examination did not reveal any gross pathologic alterations.
- Other findings:
- Areas on the fur and tail remained stained throughout the 14-day observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute Oral LD50: >15,380 mg/kg
- Executive summary:
Young albino rats derived from Sprague-Dawley stock were used as test animals.
Selected groups of albino rats were administered the test material at several dose levels. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.
After oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages and observed for the following 14 days. Initial and final body weights, mortalities, and reactions were recorded. A necropsy examination was conducted on all animals.
At the end of the observation period, the acute oral median lethal dose (LD50) of the test material was calculated.
No pharmacotoxic symptoms were exhibited by the rats dosed at 1,350 and 4,556 mg/kg following oral administration of CIBANONE Olive S Paste. In rats dosed at 15,380 mg/kg hypoactivity was observed at 1 hour, ruffed fur at 3 hours, and black feces at 5 hours. These symptoms subsided after 3 days. However areas on the fur and tail remained stained throughout the 14-day observation period.
Necropsy examination did not reveal any gross pathologic alterations.
Acute Oral LD50: >15,380 mg/kg
Mortality and Body Weight Data
Dose Level (mg/kg) |
Animal Number and Sex |
Individual Body Weight (grams) |
Number dead |
Percent dead |
|
Test Day Number: |
|||||
0 |
14 |
Number Tested |
|||
1,350 |
1-M 2-M 3-F 4-F |
214 222 170 186 |
300 320 220 234 |
0/4 |
0 |
4,556 |
5-M 6-M 7-F 8-F |
210 210 170 170 |
310 320 236 222 |
0/4 |
0 |
15,380 |
9-M 10-M 11-F 12-F |
240 202 164 180 |
340 310 230 248 |
0/4 |
0 |
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test procedure was modelled after that of Draize et al.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Black liquid identified as CIBANONE Olive S Paste, 44/121695/100/0
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young albino rabbits of the New Zealand strain were used in the evaluation of the primary skin irritating properties of the test material.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved & abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5ml, undiluted
- Duration of treatment / exposure:
- 24 hours exposure period
- Observation period:
- 72 hours
- Number of animals:
- 6 animals (sex not disclosed)
- Details on study design:
- Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit. Two test sites located lateral to the midline of the back approximately ten centimeters apart were selected. One of the two sites was abraded by making four epidermal incisions, two perpendicular to the other two, while the other test site remained intact.The test material was applied to each of the test sites on each rabbit and occluded with gauze patches which were secured with masking tape. The trunk of each animal was then wrapped with impervious plastic sheeting. The wrap held the patches in position and retarded evaporation of the test material during the 24-hour exposure period.At the end of 24 hours, the plastic wrappings, patches and all residual test material were removed. The intact and abraded test sites were examined and scored separately for erythema and edema on a graded scale of 0 to 4. After 72 hours, the sites were again examined and scored.In evaluating the average irritation present, the mean scores for erythema and edema of the intact test sites after 24 and 72 hours were added. Similarly, the mean scores for erythema and edema of the abraded test sites after 24 and 72 hours were added. These two values were totalled and divided by four to obtain the mean primary irritation score.
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin Sites
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- Extremely superficial second degree chemical burns were noted at the 24-hour scoring interval on all sites. The burns were considered too superficial to be given a maximum score of four for both erythema and edema.
- Other effects:
- None reported
- Interpretation of results:
- other: Moderately irritating
- Conclusions:
- Mean Primary Irritation Score: 3.9/8.0. The test material was moderately irritating to rabbit skin.
- Executive summary:
Young albino rabbits of the New Zealand strain were used in the evaluation of the primary skin irritating properties of the test material.
The test procedure was modelled after that of Draize et al.
Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit. One of the two sites was abraded by making four epidermal incisions, two perpendicular to the other two, while the other test site remained intact.
The test material was applied to each of the test sites on each rabbit and occluded with gauze patches which were secured with masking tape. The wrap held the patches in position and retarded evaporation of the test material during the 24-hour exposure period.
At the end of 24 hours, the plastic wrappings, patches and all residual test material were removed. The intact and abraded test sites were examined and scored separately for erythema and edema on a graded scale of 0 to 4. After 72 hours, the sites were again examined and scored.
Extremely superficial second degree chemical burns were noted at the 24-hour scoring interval on all sites. The burns were considered too superficial to be given a maximum score of four for both erythema and edema.
Mean Primary Irritation Score: 3.9/8.0
Moderately Irritating
Primary Skin Irritation - Results
Animal Number |
Irritation Scores for Abraded Skin Sites at: |
Irritation Scores for Intact Skin Sites at: |
||||||
24 Hours |
72 Hours |
24 Hours |
72 Hours |
|||||
Er. |
Ed. |
Er. |
Ed. |
Er. |
Ed. |
Er. |
Ed. |
|
1 2 3 4 5 6 |
2 2 3 3 3 3 |
2 2 2 2 2 2 |
3 3 3 3 3 3 |
1 1 0 0 0 1 |
2 2 3 3 3 3 |
1 2 1 2 2 2 |
2 3 3 3 3 3 |
0 1 0 1 0 0 |
Mean |
2.7 |
2.0 |
3.0 |
0.5 |
2.7 |
1.7 |
2.8 |
0.3 |
Subtotal |
8.2 |
7.5 |
||||||
Primary Irritation Score = 3.9 |
Er. = Erythema
Ed. = Edema
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test method was patterned after that of Draize et al.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Young albino rabbits of the New Zealand strain were used to evaluate the eye irritating properties of the test material.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eyes acted as controls
- Amount / concentration applied:
- 0.1ml undiluted
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals (sex not disclosed)
- Details on study design:
- The test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of each animal served as a control. At each scoring interval the cornea, iris, and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system. The maximum possible score at any one examination and scoring period is 110 points, which indicates maximal irritation and damage to all three ocular tissues. Zero score indicates no irritation. In this scoring system, special emphasis is placed upon irritation or damage to the cornea, while less emphasis is placed upon damage to the iris and conjunctiva.After the completion of the test, the scores were analyzed, and a descriptive eye irritation rating was assigned to the test material. The criteria used for assignment of the descriptive rating are the frequency, the extent, and the persistence of irritation or damage which occur to the three ocular tissues.The rating is obtained by selecting the maximum mean irritation score at one, 24, 48 or 72 hours after instillation. If the rate of dissipation of injury does not meet the requirements defined for the descriptive rating appropriate for a particular numerical score, the descriptive rating is raised by one or more levels.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All animals had a score of 2.0 for conjunctiva at the 1 hour time point. In all animals this score had reduced to score by 24 hours.
- Other effects:
- None reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Irritation score (Mean/Maximum): 2.0/110.0
Practically Non-irritating - Executive summary:
Young albino rabbits of the New Zealand strain were used to evaluate the eye irritating properties of the test material. The test method was patterned after that of Draize et al.
The test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of each animal served as a control. At each scoring interval the cornea, iris, and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system.
Irritation score (Mean/Maximum): 2.0/110.0
Practically Non-irritating
Eye Irritation Test - Results
Tissue |
Rabbit Number |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
Cornea (D-A) Iris Conjunctivae (R-S-D) |
1 |
0 0 2 (1-0-0) |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
2 |
0 |
0 |
0 |
0 |
|
Cornea (D-A) Iris Conjunctiva (R-S-D) |
2 |
0 0 2 (1-0-0) |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
2 |
0 |
0 |
0 |
0 |
|
Cornea (D-A) Iris Conjunctivae (R-S-D) |
3 |
0 0 2 (1-0-0) |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
2 |
0 |
0 |
0 |
0 |
|
Cornea (D-A) Iris Conjunctivae (R-S-D) |
4 |
0 0 2 (1-0-0) |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
2 |
0 |
0 |
0 |
0 |
|
Cornea (D-A) Iris Conjunctivae (R-S-D) |
5 |
0 0 2 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
2 |
0 |
0 |
0 |
|
|
Cornea (D-A) Iris Conjunctivae (R-S-D) |
6 |
0 0 2 (1-0-0) |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
2 |
0 |
0 |
0 |
0 |
|
Average Cornea Iris Conjunctivae |
|
0.0 0.0 2.0 |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
Total |
2.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Cornea: Iris: Conjunctivae:
D = Density Iris Score = Value x 5 R = Redness
A = Are Maximum Score = 10 S = Swelling
Corneal Score = D x A x 5 D = Discharge
Maximum Score = 80 Conjunctivae Score = (R+S+D) x 2
Maximum Score = 20
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute dermal toxicity study in rabbits. Observations were conducted for 14 days following dermal application.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of 3,9-dibromobenzanthrone condensed with 2 equivalents of 1-aminoanthraquinone, subsequently further condensed under oxidative conditions
- EC Number:
- 944-232-9
- Molecular formula:
- Not available - UVCB substance
- IUPAC Name:
- Reaction product of 3,9-dibromobenzanthrone condensed with 2 equivalents of 1-aminoanthraquinone, subsequently further condensed under oxidative conditions
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult albino rabbits of the New Zealand strain were used as test animals. All rabbits had been maintained under observation in the laboratory for at least seven days prior to testing. During the pre-test period, the animals were examined with respect to their general health and suitability as test animals. The rabbits were housed individually in suspended, wire-bottomed cages and maintained on a standard laboratory ration. Food and water were offered ad libitum.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. The shaved area on each animal constituted about 30 percent of the total body surface area. The animals were then returned to their cages to await testing on the following day. The 24-hour waiting period allowed recovery of the stratum corneum from the disturbance which accompanied the close-clipping procedure and permitted healing of any microscopic abrasions possibly produced during the process.The test material was applied at the highest reasonable dose level. The test site was covered by wrapping the trunk of the animal with impervious plastic sheeting which was securely taped in place. This plastic wrap insured close contact of the epidermis and test material. To prevent oral ingestion of the test material, each animal was fitted with a light-weight, flexible plastic collar which was worn throughout the observation period.At the end of the test period, the plastic sheeting and all residual test material were removed.
- Duration of exposure:
- 24 hours
- Doses:
- 3000 mg/kg
- No. of animals per sex per dose:
- 4 animals (2 male/2 female)
- Control animals:
- no
- Details on study design:
- The test sites were examined for local skin reactions and the animals were returned to their cages. Observations for mortality, local skin reactions, and behavioral abnormalities were continued for a total of 14 days following the skin applications. Initial, 7 and 14-day body weights were recorded. A necropsy examination was conducted on all animals.In the case of significant mortality following the initial study, additional experiments were conducted at lower dose levels in order to obtain data sufficient to determine the acute dermal median lethal dose (LD50).
- Statistics:
- At the end of the observation period, the acute dermal median lethal dose (LD50) of the test material was calculated, if possible, using the techniques of Weil, Thompson, and Thompson and Weil.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality reported
- Clinical signs:
- other: No pharmacotoxic symptoms were exhibited by any of the rabbits following dermal exposure to CIBANONE Olive S Paste.The test material was moderately to severely irritating to the skin of the albino rabbit. Skin changes at 24 hours were characterized by red
- Gross pathology:
- Necropsy examination revealed red lungs in rabbit No. 1-M.No other gross pathologic alterations were noted except for the local skin changes as previously described.
- Other findings:
- None reported
Any other information on results incl. tables
Mortality and Body Weight Data
Dose Level (mg/kg) |
Animal Number and Sex |
Individual Body Weights (kg) |
Number Dead |
Percent Dead |
||
Test Day Number: |
||||||
0 |
7 |
14 |
Number Tested |
|||
3,000 |
1-M* 2-M 3-F* 4-F |
2.78 2.66 2.90 2.92 |
2.86 2.72 2.96 3.00 |
2.90 2.82 3.12 3.10 |
0/4 |
0 |
* The skin at the site of application was abraded
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute Dermal LD50: > 3,000 mg/kg
- Executive summary:
Young adult albino rabbits of the New Zealand strain were used as test animals.
Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. The shaved area on each animal constituted about 30 percent of the total body surface area.
The test material was applied at the highest reasonable dose level. The test site was covered by wrapping the trunk of the animal with impervious plastic sheeting which was securely taped in place. This plastic wrap insured close contact of the epidermis and test material.
The test material remained in contact with the skin for 24 hours. At the end of this period, the plastic sheeting and all residual test material were removed. The test sites were examined for local skin reactions and the animals were returned to their cages. Observations for mortality, local skin reactions, and behavioral abnormalities were continued for a total of 14 days following the skin applications. Initial, 7 and 14-day body weights were recorded. A necropsy examination was conducted on all animals.
No pharmacotoxic symptoms were exhibited by any of the rabbits following dermal exposure to CIBANONE Olive S Paste.
The test material was moderately to severely irritating to the skin of the albino rabbit. Skin changes at 24 hours were characterized by red, well-defined erythema, moderate edema and superficial second degree burns. Mild desquamation was observed at 7 and 14 days.
Necropsy examination revealed red lungs in rabbit No. 1-M.
No other gross pathologic alterations were noted except for the local skin changes as previously described.
Acute Dermal LD50: > 3,000 mg/kg
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