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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
Endpoint summary
Administrative data
Description of key information
No classification for acute effects is required.
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:
- 15 February 2011 to 02 March 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU & OECD test guidance in compliance with GLP and reported with a valid GLP certificate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: RjHan:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: RjHan:WI rats
Source: Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX FRANCE
Hygienic level at supplier: SPF
Hygienic level during the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant.
Age of animals at dosing: Young healthy adult rats, ~ 9 weeks old
Date of receipt: 10 February 2011
Body weight at treatment: 222 – 248 g
Acclimation period: At least 5 days
Husbandry
Animal health: Only healthy animals were used for the test. The veterinarian certified the health status.
Number of animal room: 522/4
Housing: 3 animals / cage
Cage type: Type III polypropylene/polycarbonate
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 15-20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
The temperature and relative humidity were recorded twice daily during the study.
Food and Water Supply
Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum, and tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum. The food is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Water quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). The quality control results are retained in the archives at LAB Research Ltd.
Animal Identification
Animals were individually identified using numbers written on the tail with an indelible marker pen. The numbers were given on the basis of LAB Research Ltd.' s Master File, for each animal allocated to the treatment groups. The cages were identified by cards, with information about study code, sex, dose group, cage number and individual animal numbers. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL (without correction for purity)
- Amount of vehicle (if gavage): A constant treatment volume of 10 mL/kg bodyweight was applied.
- Justification for choice of vehicle: Not provided
- Lot/batch no. (if required): 7530810
- Purity: Not applicable
- Dose preparation: Test item was freshly formulated on the day of administration. The formulation container was stirred continuously during administration to ensure that the syringe was filled from a homogenous liquid.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Rationale for the selection of the starting dose: The initial dose level was selected on the basis of the information provided by the Sponsor. The LD50 value was expected to be above 2000 mg/kg bw.
Procedure:
A single oral dose was administered by gavage. The animals were fasted for about 16 hours prior to treatment. The food but not water was withheld during an overnight period. Animals were weighed just before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment. A constant treatment volume of 10 mL/kg bodyweight was applied. - Doses:
- Initially, three female animals were treated with 2000 mg/kg bw of Reactive Red F03 -0318. As no mortality occurred within 24 hours after dosing, a second group of three animals received 2000 mg/kg bw Reactive Orange F08 0314 approximately 24 hours after treatment of the first group. No mortality occurred in the second treatment group; hence, further testing was not required according to the test guidelines. The test was terminated on completion of the 14-day observation period.
- No. of animals per sex per dose:
- 3 initial female + 3 additional female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and on study days 3, 7, and 14.
- Necropsy of survivors performed: Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthasol® 40 %). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded.
- Other examinations performed: None - Statistics:
- Clinical signs, body weight, body weight gain and gross macroscopic data were tabulated.
- Preliminary study:
- Not applicable.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Reactive Red F03-0318 did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Treatment with Reactive Red F03-0318 caused reddish coloured faeces in both treated groups on Day 0 and 1 after treatment, red-brown staining of the fur in Group 1 at 6 hours after the treatment, and liquid faeces in two animals of Group 2 on the day of t
- Gross pathology:
- No test substance-related findings were noted at necropsy in Group 1 rats. In Group 2 animals, dark/pink diffuse discoloration of the skin and subcutis, kidneys, spleen, uterus, tail and/or mesenteric lymph nodes were noted at necropsy. These changes result most likely from the staining effect of the red dye and caused no adverse toxicological effects under the conditions of this study.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Reactive Red F03-0318 was found to be above 2000 mg/kg bw in female
RjHan: WI rats. According the EU criteria, Reactive Red F03-0318 should be ranked as not classified. - Executive summary:
The single-dose oral toxicity of Reactive Red F03-0318 was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008,B.1.tris) in RjHan: WI rats.
Two groups of three female RjHan:WIrats (ca.9 weeks old) were treated with Reactive Red F03-0318 at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. Rats were maintained without compound administration for a 2‑week observation period after the day of dosing. As no mortality was observedin this dose group within 24 hours after dosing, a confirmatory treatment was performed on 3 further females (Group 2) at the same dose level. As no mortality was observed in the second dose group, no further treatment was needed.
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal (about 16 hours prior to treatment). Food was made available again 3 hours after the treatment. Reactive Red F03-0318 was administered as a solution prepared in distilled waterat a concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw.
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 3 and 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.
Results
Mortality
Reactive Red F03-0318 did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical observations
Treatment with Reactive Red F03-0318 caused reddish coloured faeces in both treated groups on Day 0 and 1 after treatment, red-brown staining of the fur in Group 1 at 6 hours after the treatment, and liquid faeces in two animals of Group 2 on the day of treatment.
Body weight and body weight gain
Body weight gains of Reactive Red F03-0318 treated animals showed no indication of a treatment-related effect.
Macroscopic Findings
No test substance-related findings were noted at necropsy in Group 1 rats. In Group 2 animals, dark/pink diffuse discoloration of the skin and subcutis, kidneys, spleen, uterus, tail and/or mesenteric lymph nodes were noted at necropsy. These changes result most likely from the staining effect of the red dye and caused no adverse toxicological effects under the conditions of this study.
Conclusion:
Under the conditions of this study, the acute oral LD50value of the test item Reactive Red F03-0318 was found to be above 2000 mg/kg bw in female RjHan: WI rats. According the EU criteria, Reactive Red F03-0318 should be ranked as not classified.
Reference
CLINICAL OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw
SEX: FEMALE
Cage No. |
Animal Number |
Observations |
Observation days |
Frequency |
|||||||
0 |
1 |
2-14 |
|||||||||
30' |
1h |
2h |
3h |
4h |
6h |
||||||
1 * |
4655 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
- |
+ |
+ |
19/20 |
Red-brown staining (fur) |
- |
- |
- |
- |
- |
+ |
- |
- |
1/20 |
||
4656 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
- |
+ |
+ |
19/20 |
|
Red-brown staining (fur) |
- |
- |
- |
- |
- |
+ |
- |
- |
1/20 |
||
4657 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
- |
+ |
+ |
19/20 |
|
Red-brown staining (fur) |
- |
- |
- |
- |
- |
+ |
- |
- |
1/20 |
||
2 * |
4658 |
Symptom Free |
+ |
+ |
+ |
- |
- |
- |
+ |
+ |
17/20 |
Faeces liquid |
- |
- |
- |
+ |
+ |
+ |
- |
- |
3/20 |
||
4659 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
4660 |
Symptom Free |
+ |
+ |
+ |
- |
- |
- |
+ |
+ |
17/20 |
|
Faeces liquid |
- |
- |
- |
+ |
+ |
+ |
- |
- |
3/20 |
Remarks: +: present -: absent
h=hour (s) Treatment day= Day 0
*: Red faeces on Day 0 and 1
Frequency of observation = number of occurence of observation / total number of observations
BODY WEIGHT DATA
DOSE LEVEL: 2000 mg/kg bw
SEX: FEMALE
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||||||
|
-1 |
0 |
3 |
7 |
14 |
-1-0 |
0-3 |
3-7 |
7- 14 |
-1 - 14 |
|
|
4655 |
258 |
237 |
259 |
277 |
314 |
-21 |
22 |
18 |
37 |
56 |
1 |
4656 |
262 |
244 |
270 |
288 |
321 |
-18 |
26 |
18 |
33 |
59 |
|
4657 |
255 |
237 |
260 |
272 |
281 |
-18 |
23 |
12 |
9 |
26 |
|
4658 |
239 |
222 |
238 |
242 |
248 |
-17 |
16 |
4 |
6 |
9 |
2 |
4659 |
259 |
244 |
264 |
280 |
284 |
-15 |
20 |
16 |
4 |
25 |
|
4660 |
264 |
248 |
265 |
285 |
319 |
-16 |
17 |
20 |
34 |
55 |
Mean: |
256.2 |
238.7 |
259.3 |
274.0 |
294.5 |
-17.5 |
20.7 |
14.7 |
20.5 |
38.3 |
|
Standard deviation: |
9.0 |
9.2 |
11.2 |
16.7 |
28.8 |
2.1 |
3.8 |
5.9 |
15.7 |
21.0 |
Remark: Treatment day= Day 0
NECROPSY FINDINGS
DOSE LEVEL: 2000 mg/kg bw
SEX: FEMALE
Cage No. |
Animal ID |
Necropsy Date |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
4655 |
01 March 2011 |
No external observations recorded |
In estrus |
Uterus |
4656 |
01 March 2011 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
4657 |
01 March 2011 |
No external observations recorded |
Dark discoloration, red, diffuse, all lobes |
Lungs |
|
4658 |
02 March 2011 |
Tail: Dark discoloration, pink, diffuse |
Dark discoloration, pink, diffuse, whole body |
Skin & Subcutis |
|
2 |
4659 |
02 March 2011 |
Tail: Dark discoloration, pink, diffuse |
Dark discoloration, pink, diffuse, bilateral |
Kidneys |
Dark discoloration, pink, diffuse, whole body |
Skin & Subcutis |
||||
4660 |
02 March 2011 |
Tail: Dark discoloration, pink, diffuse |
Small |
Spleen |
|
Dark discoloration, pink, diffuse, whole body |
Skin & Subcutis |
||||
Dark discoloration, pink, diffuse, horns, bilateral |
Uterus |
||||
Dark discoloration, pink |
Lymph node, mesenteric |
||||
Dark discoloration, pink, diffuse, bilateral |
Kidneys |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study conducted in accordance with OECD, EU and US guidelines therefore Klimisch 1 study.
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:
- 23 February 2011 to 9 March 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU, US & OECD test guidance in compliance with GLP and reported with a valid GLP certificate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- the humidity (30 – 70%) was recorded out of the target range. The actual range was at the humidity 24-55 %.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- the humidity (30 – 70%) was recorded out of the target range. The actual range was at the humidity 24-55 %.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- the humidity (30 – 70%) was recorded out of the target range. The actual range was at the humidity 24-55 %.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: RjHan:(WI) Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species and strain: RjHan:(WI) Wistar rats
Source: Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX FRANCE
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Justification of strain: The Wistar rat is one of the standard rodent species used in acute toxicity studies
Number of animals: 5 animals/sex
Sex: Male and female, female rats were nulliparous and non-pregnant.
Age of animals at study start: Young adult rats
Body weight range at dosing: Between 205 g and 240 g
Acclimatization time: 6 days
Husbandry
Animal health: Only healthy animals were used for the study. The veterinarian certified the health status.
Room-Box: 245/5
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding: Lignocel Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH+Co.KG (Holzmühle 1, 73494 Rosenberg, Germany);
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 19.4- 23.8 °C
Relative humidity: 24 - 55 %
Ventilation: 15-20 air exchanges/hour
Enrichment: Rodents were housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
The temperature and relative humidity was recorded twice daily during the study.
Food and Water Supply
Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany ad libitum, and tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum. The food is not considered to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Water quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). The quality control results are retained in the archives at LAB Research Ltd.
Identification
The individual identification was performed using numbers written on the tail with a marker pen. The numbers were given on the basis of LAB Research Ltd.' s Master File for each animal allocated to the treatment groups. The cages were identified by cards containing information about study code, sex, dose group, cage number and individual animal numbers. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10 % area of the total body surface
- % coverage: approximately 10 % area of the total body surface)
- Type of wrap if used: semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.
- Time after start of exposure: 14 days
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): Not applicable
- Constant volume or concentration used: no. The appropriate amount of the test item was moistened with distilled water and distributed as uniformly as possible. - Duration of exposure:
- 14 days
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- DOSAGES
Justification of the doses:
The test item was not expected to be lethal at 2000 mg/kg bw. A limit test was therefore performed.
PROCEDURE
The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24- hour exposure period. For that purpose, the appropriate amount of the test item was moistened with distilled water and distributed as uniformly as possible. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.
At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.
OBSERVATIONS
CLINICAL OBSERVATIONS
Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
MEASUREMENT OF BODY WEIGHT
The body weights were recorded on Day 0 (before test item administration) and on Days 7 and 14.
NECROPSY
All animals were anaesthetised with Euthasol®40% (details in 3.1.3.) and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.
EVALUATION
Body weight and body weight gain are summarized in tabular form. Clinical signs and necropsy findings are described and summarized in tabular form. - Statistics:
- None
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred after a 24-hour dermal exposure to Reactive Red F03-0318 administered at 2000 mg/kg bw to RjHan:(WI) Wistar rats followed by a 14-day observation period.
- Clinical signs:
- other: No clinical signs were observed after the treatment with the test item or during the 14 day observation period.
- Gross pathology:
- At necropsy, no macroscopic test item-related findings were observed.
- Other findings:
- Red staining was recorded on the skin in all animals after dosing. The discoloration of the skin lasted up to Day 12 in all animals. No other local dermal signs were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item Reactive Red F03 0318 was found to be higher than 2000 mg/kg body weight in male and female RjHan:(WI) Wistar rats.
- Executive summary:
An acute dermal toxicity study was performed with test item Reactive Red F03-inRjHan:(WI) Wistar rats, in compliance with OECD Guideline No.: 402.
A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied, moistened with distilled water, as a single dermal 24-hour exposure followed by a 14‑day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 3, 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
The results of the study were summarized as follows:
Mortality
No mortality occurred.
Systemic clinical signs
No clinical signs were observed after the treatment with the test item or during the 14‑day observation period.
Local dermal signs
No local dermal signs were observed during the entire study period. However, red staining was observed on the skin in all animals after dosing from Day 1 to Day 12.
Body weight
The body weight and body weight gain of Reactive Red F03-0318 treated animals did not show any test item-related effect.
Necropsy
There was no evidence of test item-related observations at a dose level of 2000 mg/kg bw at necropsy. Uterus in estrus was observed in two females.
Conclusions
The acute dermal median lethal dose (LD50) of the test item Reactive Red F03‑0318 was found to be higher than 2000 mg/kg bw in male and female RjHan:(WI) Wistar rats.
Reference
CLINICAL OBSERVATIONS
Dose level: 2000 mg/kg bw
Sex: Female
Cage No. |
Animal No. |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5 h |
||||||||||||||||||
1 |
4903 |
Symptom Free |
+ |
+ |
|
|
|
|
|
|
|
|
|
|
|
+ |
+ |
+ |
5/16 |
Dark discoloration, red |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
1 1/16 |
||
2 |
4904 |
Symptom Free |
+ |
+ |
|
|
|
|
|
|
|
|
|
|
|
+ |
+ |
+ |
5/16 |
Dark discoloration, red |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
1 1/16 |
||
3 |
4905 |
Symptom Free |
+ |
+ |
|
|
|
|
|
|
|
|
|
|
|
|
+ |
+ |
4/16 |
Dark discoloration, red |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
12/16 |
||
4 |
4906 |
Symptom Free |
+ |
+ |
|
|
|
|
|
|
|
|
|
|
|
+ |
+ |
+ |
5/16 |
Dark discoloration, red |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
1 1/16 |
||
5 |
4907 |
Symptom Free |
+ |
+ |
|
|
|
|
|
|
|
|
|
|
|
|
+ |
+ |
4/16 |
Dark discoloration, red |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
12/16 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study conducted in accordance with OECD, EU and US guidelines therefore Klimisch 1 study.
Additional information
Testing on the above endpoints gave the following results:
Acute toxicity: Oral.
- LD50: >2000 mg/kg
Acute toxicity: Dermal.
- LD50: >2000 mg/kg
Acute toxicity: Inhalation.
Not measured.
Justification for selection of acute toxicity – oral endpoint
Only 1 study available.
Justification for selection of acute toxicity – inhalation endpoint
The test substance has a predicted very low vapour pressure and is a granular product, hence the potential for the generation of inhalable forms is low. In addition the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Dermal exposure is considered to be the appropriate route of exposure and has been assessed accordingly. No acute inhalation test was performed.
Justification for selection of acute toxicity – dermal endpoint
Only 1 study available.
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.
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.