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EC number: 281-865-3 | CAS number: 84045-63-6
- 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
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Yellow 095, where the sulphonate group is bound at the meta-position of the amino benzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Yellow 095.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Yellow 095 meta/para (CAS# --- / EC# 944-218-2)
Target: Reactive Yellow 095 meta (CAS# 84045-63-6 / EC# 281-865-3)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.12 Auto flammability - Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 in rats was determined to be >2000 mg/kg bw.
- Executive summary:
The source substance was administered to groups of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of the source substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg. The structurally related target substance will show the same behaviour and therefore it can be anticipated that the acute oral LD50 will be >2000 mg/kg bw as well.
This is confirmed by 3 supporting studies performed with the source substance, showing LD50 values of >5000 mg/kg bw (twice) and 14530 mg/kg bw, respectively.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- None
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- other: Tif RAI strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 100 and 105 g
- Fasting period before study: Overnight
- Housing: macrolon cages (Size 3)
- Diet (e.g. ad libitum): standard diet of Nafag ad libitum
- Water (e.g. ad libitum):access of drinking water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-1°C
- Humidity (%): 55+5%
- Photoperiod (hrs dark / hrs light): 14-hour light period.
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- None
- Doses:
- 1000, 3000, 10000 and 15000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- None
- Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 14 530 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: ataxia, dyspnoea, ventricumbency, slight muscular hypotonia, slight inhibition of the response to pain
- Gross pathology:
- No substance related gross organ changes were seen.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of compound FAT 40000 in rats is 14530 mg/kg bw.
- Executive summary:
The acute oral toxicity of FAT 40000 was evaluated rats.1000, 3000, 10000 and 15000 mg/kg dose were administered. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. ataxia, dyspnoea, ventricumbency, slight muscular hypotonia, slight inhibition of the response to pain were observed. At autopsy no changes caused by the administration of FAT 40000 were seen. In conclusion, the acute oral LD50 of FAT 40000 in rats of both sexes observed over a period of 14 days is 14530 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 153-218 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4 with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat fpod ad libitum
- Water (e.g. ad libitum): water ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3° C
- Humidity (%): 55+15%
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- None
- Doses:
- 3000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- None
- Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Dyspnoea, exophthalmus, ruffled fur and curved body position are symptoms commonly seen during the observation time following administration of substances by gavage.
- Gross pathology:
- No substance related gross organ changes were seen.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of compound FAT 40000/D in rats is greater than 5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of FAT 40000/D was evaluated rats.3000 and 5000 mg/kg dose were administered. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Dyspnoea, exophthalmus, ruffled fur and curved body position are symptoms commonly seen during the observation time following administration of substances by gavage. At autopsy no changes caused by the administration of FAT 40000/D were seen.In conclusion, the acute oral LD50 of FAT 40000 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- None
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 166-225 g
- Fasting period before study: overnight
- Housing: Macrolon cages
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum): water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3°C
- Humidity (%): 55+-15%
- Air changes (per hr): 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
- Details on oral exposure:
- None
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- None
- Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Dyspnoea, exophthalmos, ruffled fur, diarrhoea, body position curved
- Gross pathology:
- No substance related gross organ changes were seen.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of compound FAT 40000/E in rats is greater than 5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of FAT 40000/E was evaluated rats.5000 mg/kg dose was administered. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Dyspnoea, exophthalmos, ruffled fur, diarrhoea, body position (curved) were observed. At autopsy no changes caused by the administration of FAT 40000/E were seen.In conclusion, the acute oral LD50 of FAT 40000 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 8 weeks females: 10 weeks
- Weight at study initiation: males: 199 - 209 g females: 165 - 179 g
- Fasting: overnight
- Housing: Makrolon type-3 cages (size: 22 x 37.5 x 15 cm) with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard
- Water (e.g. ad libitum): Community tap water
- Acclimation period: One week under laboratory conditions, after veterinary examination. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3 °C
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bidistilled
- Details on oral exposure:
- None
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 anmals per dose
- Control animals:
- yes
- Details on study design:
- None
- Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study period.
- Clinical signs:
- other: NO clinical signs were noted in the animals.
- Gross pathology:
- No macroscopical organ findings were observed.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of compound FAT 40000/G in rats is greater than 2000 mg/kg bw.
- Executive summary:
The test article FAT 40000/G was administered to groups of 5 male and 5 female rats by oral gavage, at single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of FAT 40000/G in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.
Referenceopen allclose all
None
None
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Based on Column 2 of the table given in REACH Annex VIII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the very low vapour pressure of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the inhalation route of exposure is considered to be unlikely, thus the study on acute inhalation toxicity is being waived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Yellow 095, where the sulphonate group is bound at the meta-position of the amino benzene moiety. The source chemical for most endpoints is the reaction mass of both the meta-isomer and the para-isomer of Reactive Yellow 095. The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
For this endpoint, the source chemical is Reactive Yellow 175 instead. This source chemical is used as it is also used by the registrants of the reaction mass of the meta-isomer and para-isomer of Reactive Yellow 095 to cover this endpoint.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Yellow 175 (CAS# 111850-27-2 / EC# 402-740-3)
Target: Reactive Yellow 095 meta (CAS# 84045-63-6 / EC# 281-865-3)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.12 Auto flammability - Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity LD50 in rat was determined to be >2000 mg/kg bw.
- Executive summary:
In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were exposed to the source substance (2000 mg/kg bw). The test substance was dissolved in a 4 % CMC solution and applied on the skin with a syringe and covered with an occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. The toxicity of the test substance was estimated to be >2000 mg/kg bw.
The structurally related target substance will show similar behaviour.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, / Switzerland
- Age at start of treatment: 8 to 9 weeks
- Weight at start of treatment: Males: 212 - 221 g, Females: 162-185 g
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, Switzerland).
- Diet: Pelleted standard Kliba 343, Batch 77/87 rat maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland), available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: At least one week under laboratory conditions, after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 4% in distilled water
- Details on dermal exposure:
- Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface. On test day 1, 4mL of the test article was applied evenly on the skin with a syringe and covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water and dried with disposable paper towels and the skin reaction was assessed according to the method of Noakes, D.N. and Sanderson, D.M. "A method for determining the dermal toxicity of pesticides". Brit. J. Industr. Med., 26, 59-64, 1969)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality/viability were measured four times during test day 1 and daily during days 2 - 15.
- Body weights were measured on day 1 (pre administration), 8 and 15.
- All animals were necropsied.
- Each animal had an examination for changes in appearance and behavior four times during day 1, and daily during days 2-15 (general behaviour, respiration, eye, nose, motility, body posture, motor susceptibility, skin) - Statistics:
- The Logit model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0%
- Clinical signs:
- other: The rats showed yellowish discolored skin at the application site.
- Gross pathology:
- In two animals, several dark-red foci were observed in the lung.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity of the test substance was estimated to be greater than 2000 mg/kg bw
- Executive summary:
In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were exposed to the source substance (2000 mg/kg bw). The test substance was dissolved in a 4 % CMC solution and applied on the skin with a syringe and covered with an occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. The toxicity of the test substance was estimated to be >2000 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The source substance was administered to groups of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of the source substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg. The structurally related target substance will show the same behaviour and therefore it can be anticipated that the acute oral LD50 will be >2000 mg/kg bw as well.
This is confirmed by 3 supporting studies performed with the source substance, showing LD50 values of >5000 mg/kg bw (twice) and 14530 mg/kg bw, respectively.
A different source substance, REACTIVE YELLOW 175, was evaluated for the acute toxicity via dermal route.
In this GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were exposed to 2000 mg/kg bw (RCC 1987). No mortality was observed during the observation period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. The dermal LD50of the test substance was estimated to be >2000 mg/kg bw.
Justification for classification or non-classification
Based on the above assessment of the acute oral and dermal toxicity, the substance does not need to be classified for acute oral or dermal toxicity according to CLP (Regulation (EC) No 1272/2008).
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.