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EC number: 689-188-9 | CAS number: 149343-84-0
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral
LD50: >2000 mg/kg bw (male/female Sprague -Dawley strain rat)
Acute toxicity: dermal
LD50: >2000 mg/kg bw (male/female Sprague-Dawley strain rat)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 April 1993 to 8 June 1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals (1987) No. 401 "Acute Oral Toxicity"
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Method B1 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Specification
Male and female Sprague-Dawley strain rats were supplied by Charles River (UK) Ltd., Manston, Kent, U.K. At the start of the main study the males weighed 138 – 165 g, and the females 122 – 134 g, and were approximately five to eight weeks old. After a minimum acclimatization period of at least five days the animals were selected at random and given a unique number within the study by indelible ink marking on the tail and a number written on a cage card.
Husbandry
The animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 – 22 °C and relative humidity of 48 - 54%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in distilled water.
- Doses:
- Single dose: 2000 mg/kg
- No. of animals per sex per dose:
- Range-finding study: 2 (1 male/1 female)
Main Study: 10 (5 males/5 females) - Control animals:
- no
- Details on study design:
- Range-finding Study
A range-finding study was performed to establish a dosing regime.
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.
Main Study
Based on the results of the range-finding study a further group of animals was treated.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Preliminary study:
- There were no deaths or clinical signs of toxicity.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- Blue-coloured urine was noted in all animals. Blue-coloured staining of the fur was noted in all animals. All animals recovered two days after dosing .
- Body weight:
- All animals showed expected gain in bodyweight during the study.
- Gross pathology:
- All animals showed dark blue-coloured outer cortex of the kidneys at necropsy. The females also showed blue-coloured staining of the non-glandular epithelium of the stomach.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LDso) of the test material, JPR BLUE 100, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labelling regulations.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 401 "Acute Oral Toxicity" referenced as Method B1 in Commission Directive 92/ 69/ EEC (which constitutes Annex V of Council Directive 67/ 548/ EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/ 548/ EEC (as adapted to technical progress by Commission Directive 91/325/ EEC).
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.
There were no deaths. Blue-coloured urine was noted in all animals.
All animals recovered two days after dosing.
All animals showed expected gain in bodyweight during the study.
All animals showed dark blue-coloured outer cortex of the kidneys at necropsy. The females also showed blue-coloured staining of the non-glandular epithelium of the stomach.
The acute oral median lethal dose (LD50) of the test material in the Sprague -Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labelling regulations.
Reference
JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE RANGE-FINDING STUDY
Dose Level mg/kg |
Animal Number & Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
|||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
||
2000 |
1-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE MAIN STUDY
Dose Level mg/kg |
Animal Number & Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
3-0 Male |
0 |
0 |
0 |
0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-1 Male |
0 |
0 |
0 |
0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Male |
0 |
0 |
Fs0 |
Fs0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 Male |
0 |
0 |
0 |
0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-4 Male |
0 |
0 |
0 |
0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-0 Female |
0 |
0 |
Fs0 |
Fs0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-1 Female |
0 |
0 |
0 |
Fs0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-2 Female |
0 |
0 |
0 |
0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 Female |
0 |
0 |
Fs0 |
Fs DuB |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-4 Female |
0 |
0 |
0 |
0 |
Fs DuB |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = no signs of systemic toxicity DuB = blue coloured urine
Fs = blue coloured staining of the fur
JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT GAIN IN THE MAIN STUDY
Dose Level mg/kg |
Animal Number & Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
3-0 Male 3-1 Male 3-2 Male 3-3 Male 3-4 Male 4-0 Female 4-1 Female 4-2 Female 4-3 Female 4-4 Female |
161 150 165 138 164 122 132 130 134 128 |
226 238 240 202 287 178 190 179 175 171 |
287 290 308 254 295 206 221 203 195 188 |
65 88 75 64 73 56 58 49 41 43 |
61 52 68 52 58 28 31 24 20 17 |
JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL NECROPSY FINDINGS IN THE MAIN STUDY
Dose Level mg/kg |
Animal Number & Sex |
Time of Death |
Macroscopic Observations |
2000 |
3-0 Male |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region |
3-1 Male |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region |
|
3-2 Male |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region |
|
3-3 Male |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region |
|
3-4 Male |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region |
|
4-0 Female |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining |
|
4-1 Female |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining |
|
4-2 Female |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining |
|
4-3 Female |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining |
|
4-4 Female |
Killed day 14 |
Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 May 1993 to 8 June 1993 .
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity"
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- Method B3 in Commission Directive 92/ 69/ EEC (which constitutes Annex V of Council Directive 67/ 548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Specification
Five male and five female Sprague-Dawley strain rats were supplied by Charles River (UK) ltd., Manston, Kent,U. K. At the start of the study the males weighed 204 – 226 g, and the females 200 – 222 g, and were approximately ten to fourteen weeks old. After a minimum acclimatisation period of at least five days the animals were selected at random and given a unique number within the study by indelible ink marking on the tail and a number written on a cage card.
Husbandry
The animals were housed in suspended polypropylene cages furnished with softwood sawdust. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study. Free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 – 23 °C and relative humidity of 48 - 54%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness. - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approximately 5 cm x 4 cm.
A group of five male and five female rats were treated with the test material at a dose level of 2000 mg/kg.
The appropriate amount of the undiluted test material, as received, was pre-weighed into a glass vial. The test material was then applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area) which had previously been moistened with distilled water. A piece of surgical gauze was placed over the treatment area and semi -occluded with a piece of self-adhesive bandage (HYPERTIE). The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24-hour exposure period.
Shortly after dosing the dressings were examined to ensure that they were securely in place. After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were returned to group housing for the rest of the study . - Duration of exposure:
- 24 hours
- Doses:
- Single dose of 2000 mg/kg
- No. of animals per sex per dose:
- 10 animals (5 males/5 females)
- Control animals:
- no
- Details on study design:
- The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
The animals were also observed for any dermal reactions after removal of the dressings and subsequently once daily for the remainder of the study.
Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- No signs of systemic toxicity were noted during the study. Blue coloured staining of the fur was commonly noted.
- Body weight:
- All animals showed expected gain in bodyweight during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No signs of skin irritation were noted during the study. Blue coloured staining of the treatment site was commonly noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material, JPR BLUE 100, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol or risk phrase is required according to EEC labelling regulations.
- Executive summary:
A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity" referenced as Method B3 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/ 548/ EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/ 548/EEC (as adapted to technical progress by Commission Directive 91/325/ EEC).
A group of ten animals (five males and five females) was given a single 24 -hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study.
All animals showed expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/ kg bodyweight. No symbol or risk phrase is required according to EEC labelling regulations.
Reference
JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA
Dose Level mg/kg |
Animal Number & Sex |
Effects Noted After Initiation of Exposure (Hours) |
Effects Noted After Initiation of Exposure (Days) |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Male |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
1-1 Male |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 Male |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
|
1-3 Male |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 Male |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
|
2-0 Female |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 Female |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 Female |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
|
2-4 Female |
0 |
0 |
0 |
0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
Fs0 |
0 |
0 |
0 |
0 |
0 |
0 = no signs of systemic toxicity
Fs = blue coloured staining of the fur
JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL DERMAL REACTIONS
Dose Level mg/kg |
Animal Number & Sex |
Observation |
Effects Noted After Initiation of Exposure (Days) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2000 |
1-0 Male |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
1-1 Male |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
1-2 Male |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
1-3 Male |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
1-4 Male |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
2-0 Female |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
2-1 Female |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
2-2 Female |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
2-3 Female |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
|
2-4 Female |
Erythema Oedema Other |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
0 0 STA |
STA = blue-coloured staining of the treatment site
0 = no signs of dermal irritation
JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT GAIN
Dose Level mg/kg |
Animal Number & Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Male 1-1 Male 1-2 Male 1-3 Male 1-4 Male 2-0 Female 2-1 Female 2-2 Female 2-3 Female 2-4 Female |
225 226 204 208 219 220 222 200 209 213 |
262 275 267 257 274 230 241 203 223 234 |
300 325 324 310 329 260 270 211 253 257 |
37 49 63 49 55 10 19 3 14 21 |
38 50 57 53 55 30 29 8 30 23 |
JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT
INDIVIDUAL NECROPSY FINDINGS
Dose Level mg/kg |
Animal Number & Sex |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Male 1-1 Male 1-2 Male 1-3 Male 1-4 Male 2-0 Female 2-1 Female 2-2 Female 2-3 Female 2-4 Female |
Killed day 14 Killed day 14 Killed day 14 Killed day 14 Killed day 14 Killed day 14 Killed day 14 Killed day 14 Killed day 14 Killed day 14 |
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1
Additional information
Acute toxicity: oral
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat.
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.
There were no deaths. Blue-coloured urine was noted in all animals. All animals recovered two days after dosing. All animals showed expected gain in bodyweight during the study. All animals showed dark blue-coloured outer cortex of the kidneys at necropsy. The females also showed blue-coloured staining of the non-glandular epithelium of the stomach.
The acute oral median lethal dose (LD50) of the test material in the Sprague -Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
Acute toxicity: dermal
A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat.
A group of ten animals (five males and five females) was given a single 24 -hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/ kg bodyweight.
Justification for classification or non-classification
Acute toxicity: oral
The acute oral median lethal dose (LD50) of the test material in the Sprague -Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labelling regulations.
Acute toxicity: dermal
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/ kg bodyweight. No symbol or risk phrase is required according to EEC labelling regulations.
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