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EC number: 474-870-9 | 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
Endpoint summary
Administrative data
Description of key information
Testing for acute toxicity gave the following results:
Acute oral toxicity: LD50: >2000 mg/kg
Acute dermal toxicity: LD50: >2000 mg/kg
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:
- 08 May 2007 to 23 May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: CRL:(WI) BR rats
Source: CHARLES RIVER (EUROPE) LABORATORIES INC. TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
Justification of strain: The Wistar rat as a rodent is one of the standard animal in toxicity studies.
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant.
Age of animals: Young healthy adult rats, less than 10 weeks old
Date of receipt: 03 May 2007
Body weight at treatment: Between range of 184 g and 188 g
Acclimatization time: 5 and 6 days (Group 1 and Group 2)
Animal health: Only healthy animals were used for the test. The veterinarian certified healthy status.
Number of animal room: 245-8
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: Laboratory bedding
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 8-12 air exchanges/hour by central air-condition system.
Food and Water Supply: The 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, and tap water from municipal supply, as for human consumption from 500 ml bottle ad libitum.
The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Animal Identification The individual identification was performed by numbers on the tail written with a marker pen. 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
Name: Distilled water
Batch No: 8991006
Expiry Date: October 2009
Supplier: Humantrade Ltd.
Storage: At room temperature
Formulation
For treatment the test item was applied in a concentration of 200 mg/ml in distilled water. Formulations were prepared just before the administration and stirred with a magnetic stirrer up to end of the treatment. - Doses:
- Doses
Justification of the dose:
Starting dose was selected on the basis of the information provided by the Sponsor.
The LD50 value was expected to be above 2000 mg/kg bw. A limit test was performed at 2000 mg/kg bw dose.
Three female animals were treated with a dose level of 2000 mg/kg bw of Gelb Sulfato in the first step. - No. of animals per sex per dose:
- 6 animals all female, 3 animals/group
- Control animals:
- yes
- Details on study design:
- A single oral administration - followed by a fourteen-day observation period – was performed by gavage. On the day before each treatment the animals were fasted. The food but not water was withheld during an overnight period. Animals were weighed just before the treatment. The test item was administered by oral gavage in the morning hours. The food was given back 3 hours after the treatment. A constant treatment volume of 10 ml/kg body weight was applied.
Clinical Observations
Careful clinical observation was made 15 and 30 minutes, 1 h, 2 h, 3 h, 4 h, 6 h after the treatment and once each day 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 as well. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weight Measurement
The body weight was recorded on day 0 (shortly before the treatment), then on days 7 and 14 with precision of 1g.
NECROPSY
Gross necropsy was performed in each experimental animal terminally. Animals were sacrificed by exsanguination under pentobarbital anaesthesia. After the examination of the external appearance the cranial, thoracic and the abdominal cavities were opened, the organs and the tissues were observed.
Abnormalities were recorded on post mortem data sheets. - Statistics:
- No data
- Preliminary study:
- Three female animals were treated with a dose level of 2000 mg/kg bw of Gelb Sulfato in the first step. All animals survived; so three further animals were dosed at 2000 mg/kg bw dose level next day, as the second step. No mortality occurred in either steps, therefore the test was finished meeting the stopping criteria of guidelines (OECD 423, Directive 2004/73/EC B.1.tris, OPPTS 870.1100).
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Gelb Sulfato caused no mortality in female CRL:(WI) BR rats after a single oral (by gavage) administration of 2000 mg/kg bw.
- Clinical signs:
- other: Group 1 – 2000 mg/kg bw Slight activity decrease, hunched back and piloerection were noted for one animal (1/3) two hours after the treatment. There were no test item effect on the physical condition and behaviour of the remaining animals (2/3). Yellow co
- Gross pathology:
- No macroscopic alterations related to the toxic effect of Gelb Sulfato were found at necropsy. Hydrometra (1/3, Group 1) is a common necropsy findings in experimental rats related to the sexual cycle of animals. The pinprick-sized haemorrhages (1/3 in Group 2) observed in the lungs were due to the exsanguination.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 value of the test item Gelb Sulfato proved to be greater than 2000 mg/kg body weight in female CRL:(WI) BR rats.
- Executive summary:
An acute oral toxicity study was performed to assess the acute toxicity of test item Gelb Sulfato in rats. The results of the study allowed the test item to be ranked according to the classification systems, currently in use.
The acute toxic class method according to OECD 423 and Directive 2004/73/EC B.1. tris was performed with Gelb Sulfato. The study was performed in accordance with the Principles of Good Laboratory Practice (GLP) and reported with a GLP certificate.
Two groups of three female CRL:(WI) BR Wistar rats were treated by single oral gavage with Gelb Sulfato at dose levels of 2000 mg/kg bw in two independent experiments (Treatment group 1 and Treatment group 2). A concentration of 200 mg/ml prepared with distilled water corresponding to a treatment volume of 10 ml/kg bw was used at both steps.
Clinical observations were performed for all animals 15 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Food was made available again 3 hours after the treatment. Body weight was measured weekly. Gross necropsy was performed on all animals at termination of examination (day 14).
Results
Mortality:No mortality occurred after a single oral administration of Gelb Sulfato at 2000 mg/kg bw dose level in female CRL:(WI) BR rats.
Treatment group:
1
2
Dose level (mg/kg bw):
2000
2000
Number of animals treated
3
3
Mortality:
0/3
0/3
Clinical symptoms:Slight activity decrease, hunched back and piloerection were noted for one animal (1/6) two hours after the treatment. There were no test item effect on the physical condition and behaviour of the remaining animals. Yellow coloured urine and faces were noted on the day of the treatment and on the next day.
Body weight and body weight gain:The mean body weight and the body weight gain of animals were in the normal range during the two weeks observation period, similar to the expected values in untreated animals of the same age and strain.
Necropsy
No macroscopic alterations related to the toxic effect of Gelb Sulfato were found
Conclusion:
The acute oral LD50value of the test item Gelb Sulfato was greater than 2000 mg/kg body weight in female CRL:(WI) BR rats.
Gelb Sulfato does not meet the requirements of EU labelling regulations.
Reference
CLINICAL OBSERVATIONS
SUMMARY OF OBSERVATION
Observations |
Frequency of symptoms |
|
Group 1 2000 mg/kg bw |
Group 2 2000 mg/kg bw |
|
Normal |
2/3 |
3/3 |
Decreased activity |
1/3 |
0/3 |
Hunched back |
1/3 |
0/3 |
Piloerection |
1/3 |
0/3 |
Comment: Frequency: number of animals with observation / number of animals observed
INDIVIDUAL CLINICAL OBSERVATIONS
Group 1 |
Animal Number |
Observations |
Day 0 |
Day 1-14 |
F |
||||||
15’ |
30’ |
1h |
2h |
3h |
4h |
6h |
|||||
2000 mg/kg bw |
5638 |
Normal |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
21/21 |
5640 |
Normal |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
21/21 |
|
5646 |
Normal |
+ |
+ |
+ |
- |
+ |
+ |
+ |
+ |
20/21 |
|
Deceased activity |
- |
- |
- |
+ |
- |
- |
- |
- |
1/21 |
||
Hunched back |
- |
- |
- |
+ |
- |
- |
- |
- |
1/21 |
||
Piloerection |
- |
- |
- |
+ |
- |
- |
- |
- |
1/21 |
||
|
|||||||||||
Group 2 |
Animal Number |
Observations |
Day 0 |
Day 1-14 |
F |
||||||
15’ |
30’ |
1h |
2h |
3h |
4h |
6h |
|||||
2000 mg/kg bw |
5644 |
Normal |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
21/21 |
5645 |
Normal |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
21/21 |
|
5647 |
Normal |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
21/21 |
Comments: F = Frequency of observation = number of occurrence of observation / total number of observations per animal
+ = Observation present; - = Observation no present;
‘ = Minutes
h = hour
NECROPSY FINDINGS
TEST ITEM: GELB SULFATO |
TEST SYSTEM: CRL: (WI) BR RAT |
STUDY CODE: 07/425-001P |
||||||
MODE OF ADMINISTRATION: ORAL |
SEX: FEMALE |
DURATION OF STUDY: 14 DAYS |
||||||
DOSE: 2000 MG/KG BW |
NUMBER OF ANIMALS: 3/3 |
DATE OF NECROPSY: 22 MAY 2007 |
||||||
NECROPSY FINDINGS PER ORGANS |
ANIMAL NUMBERS: |
5638 |
5640 |
5646 |
/ |
/ |
NECROPSY FINIDINGS |
|
Σ |
% |
|||||||
Uterus |
Hydrometra |
+ |
- |
- |
/ |
/ |
1 |
33 |
No organs with macroscopic findings |
- |
+ |
+ |
/ |
/ |
2 |
66 |
|
|
||||||||
TEST ITEM: GELB SULFATO |
TEST SYSTEM: CRL: (WI) BR RAT |
STUDY CODE: 07/425-001P |
||||||
MODE OF ADMINISTRATION: ORAL |
SEX: FEMALE |
DURATION OF STUDY: 14 DAYS |
||||||
DOSE: 2000 MG/KG BW |
NUMBER OF ANIMALS: 3/3 |
DATE OF NECROPSY: 23 MAY 2007 |
||||||
NECROPSY FINDINGS PER ORGANS |
ANIMAL NUMBERS: |
5644 |
5645 |
5647 |
/ |
/ |
NECROPSY FINDINGS |
|
Σ |
% |
|||||||
LUNGS |
Pinprick-sized haemorrhages |
+ |
- |
- |
/ |
/ |
1 |
33 |
No organs with macroscopic findings |
- |
+ |
+ |
/ |
/ |
2 |
66 |
COMMENT: NO ALTERATION = -
ALTERATION PRESENT = +
NO DATA = /
GRADE OF ALTERATION 1 = SLIGHT /SMALL / FEW
2 = MODERATE / M.SIZE / M. NUMBER
3 = MARKED / MANY / LARGE
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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
An acute oral toxicity study was performed to assess the acute toxicity of test item Gelb Sulfato in rats. The acute toxic class method according to OECD 423 and Directive 2004/73/EC B.1. tris was performed with Gelb Sulfato. Two groups of three female CRL:(WI) BR Wistar rats were treated by single oral gavage with Gelb Sulfato at dose levels of 2000 mg/kg bw in two independent experiments (Treatment group 1 and Treatment group 2). A concentration of 200 mg/ml prepared with distilled water corresponding to a treatment volume of 10 ml/kg bw was used at both steps. Clinical observations were performed for all animals 15 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Food was made available again 3 hours after the treatment. Body weight was measured weekly. Gross necropsy was performed on all animals at termination of examination (day 14).
No mortality occurred after a single oral administration of Gelb Sulfato at 2000 mg/kg bw dose level in female CRL:(WI) BR rats. Slight activity decrease, hunched back and piloerection were noted for one animal (1/6) two hours after the treatment. There were no test item effect on the physical condition and behaviour of the remaining animals. Yellow coloured urine and faces were noted on the day of the treatment and on the next day. The mean body weight and the body weight gain of animals were in the normal range during the two weeks observation period, similar to the expected values in untreated animals of the same age and strain.
No macroscopic alterations related to the toxic effect of Gelb Sulfato were found
In conclusion, the acute oral LD50 value of the test item Gelb Sulfato was greater than 2000 mg/kg body weight in female CRL:(WI) BR rats.
Gelb Sulfato does not meet the requirements of EU labelling regulations.
The acute dermal toxicity of test item Gelb Sulfato was assessed in rats to provide information on health hazards likely to arise from 24-hour exposure by the dermal route. A limit test according to OECD 402 and B.3. 92/69/EEC was performed with Gelb Sulfato in CRL: (WI) BR rats. Five male and five female animals were treated with Gelb Sulfato for a single 24-hour dermal exposure in its original form at a dose level of 2000 mg/kg bw. Clinical examinations were made on the day of treatment 1 h and 5 h after the application of the test item, and once each day for 14 days thereafter. The body weights of animals were recorded on day 0 and weekly thereafter. A gross necropsy was performed in all animals at the end of observation period.
No mortality occurred during the entire study period. Gelb Sulfato caused yellow – red discolouration of the treated skin for 2 - 9 days after the patch removal.
There were no behavioural changes or general toxic signs. Behaviour and general state of animals were considered to be normal. The body weight development was not influenced by the single dermal treatment with the test item Gelb Sulfato. Test item related specific macroscopic alterations were not found.
Under the conditions of the present study, single 24-hour dermal administration of the test item, Gelb Sulfato did not cause mortality and toxic dermal alterations in male and female CRL:(WI)BR rats. The acute dermal LD50 value of the test item Gelb Sulfato was greater than 2000 mg/kg bw in male and female CRL:(WI) BR rats.
Gelb Sulfato does not meet the criteria for classification according to EU labelling regulations for classification and labelling of dangerous substances.
The test substance has a presumed very low vapour pressure and is a granular or well dedusted product, hence the potential for the generation of inhalable forms is low. In addition, production and use is done in a closed process without isolation of reaction products. The isolated product are dust free granules or well dedusted powder (non-dusty solid) which may be formulated into a liquid preparation of low volatility and 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 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.
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