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EC number: 231-303-8 | CAS number: 7488-56-4
- 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 via Oral Route
Key value determined in a GLP accredited laboratory study using the acute toxicity class method, in accordance with OECD Guideline 423, and Commission
Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris.
The oral LD50 value of selenium disulphide in Wistar female rats was established to be between 300 - 2000 mg/kg bw.
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:
- From 19 September 2017 - 24 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- see "Any other information on materials and methods incl. tables" for more details.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- see "Any other information on materials and methods incl. tables" for more details.
- Principles of method if other than guideline:
- Hungarian GLP Regulations: 42/2014. (VIII. 19.) EMMI decree of the Ministry of Human Capacities which corresponds to the OECD GLP, ENV/MC/CHEM (98) 17.
EPA Health Effects Test Guidelines (OPPTS 870.1100), United States, EPA 712-C-98-190 (1998) - GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Test item name: Selenium Disulphide
CAS Number: 7488-56-4
Batch/Lot Number: PMC / 285 / 16
Description: Orange/yellow powder
Expiry Date: 24 November 2019
Purity: 100%
Storage Conditions: Room temperature (between 5oC and 30oC), protected from light
Safety precautions: Enhanced safety precautions were applied considering the supplied safety datasheet to assure personnel health and safety.
Hazards: Toxic if inhaled.
Toxic if swallowed. - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:WI Wistar rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Number of animals: 18 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant
Age of animals at dosing: Young healthy adult rats, 8-10 weeks old
Body weight at treatment: 186 - 240 g
Acclimatisation period: At least 5 days
Husbandry
Animal health: Only healthy animals were used for the test. The health status was certified by the staff Veterinarian.
Number of animal room: 522/8
Housing: 3 animals/cage
Cage type: Type II. polypropylene/polycarbonate
Bedding: Lignocel 3/4-S Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH + CO.KG (D-73494 Rosenberg, Germany) was available to animals during the study.
Nesting: Arbocel crinklets natural produced by J. Rettenmaier & Söhne GmbH + CO.KG (D-73494 Rosenberg, Germany) was available to animals during the study.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.2 – 23.3 °C
Relative humidity: 33 – 80 %
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 acclimatisation period and throughout the study.
Food and Water Supply
Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany (Batch number: 262 21592, Expiry date: 31 January 2018), ad libitum, and tap water from the municipal supply, as for human consumption from a 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 Attila u. 36., Hungary). The quality control results are retained in the archives at CiToxLAB Hungary Ltd.
Animal Identification
Animals were individually identified using numbers written on the tail with an indelible pen. The numbers were given on the basis of CiToxLAB Hungary 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:
- methylcellulose
- Details on oral exposure:
- Formulation
The test item was freshly formulated at the concentrations of 5, 30 and 200 mg/mL in the vehicle, in the Pharmacy of CiToxLAB Hungary Ltd. on the day of administration. The formulation container was magnetic stirred continuously up to the end of dose administration procedures.
Procedure
A single oral gavage administration was followed by a 14-day observation period. On the night before treatment, the animals were fasted. The food but not water was withheld during an overnight period. Animals were weighed before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment.
Justification of the doses:
A limit test was not performed as the toxicity of the test substance was unknown at 2000 mg/kg bodyweight (bw). In agreement with the Sponsor, in the main test a starting dose of 300 mg/kg bw was selected based on the information provided by the Sponsor.
Initially, three females (Group 1) were treated at a dose level of 300 mg/kg bw. As no mortality and no severe symptoms were observed after 24 hours, a confirmatory group (Group 2) was treated at the same dose level.
After the 48-hour observation time point, one animal died unexpectedly in Group 1; however, as this animal was symptom-free before death and other animals were symptom-free also, the next group (Group 3) was treated at the dose level of 2000 mg/kg bw according to OECD 423. As no mortality was observed and only very minor symptoms were seen in the treated groups, a confirmatory group (Group 4) was treated at the dose level of 2000 mg/kg. Due to delayed toxicity, one further animal was found dead in Group 1 and more severe symptoms appeared later in the experiment in other treated animals also: 2 out of 3 animals died in Group 3 and 3 out of 3 animals died in Group 4.
Since 2 out of 3 animals from Group 1 died (delayed death , following the OECD scheme, three further animals were treated at a dose level of 50 mg/kg bw (Group 5). As no mortality was observed, a confirmatory group (Group 6) was treated at the same dose level. No mortality was observed in the confirmatory group; therefore, no further testing was required according to OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris. - Doses:
- 50 mg/kg body weight
300 mg/kg body weight
2000 mg/kg body weight - No. of animals per sex per dose:
- Six groups of three female Crl:WI rats were treated with the test item at the dose levels of 300 (Group 1 and 2), 2000 (Group 3 and 4) and 50 mg/kg body weight (bw) (Group 5 and 6).
- Control animals:
- not specified
- Details on study design:
- Clinical observations
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 or until death. 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.
Body Weight Measurement
The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0), weekly thereafter and at necropsy (Day 14) or at death. Additional measurements were performed on Day 4 in Group 2 and on Day 3 in Group 3.
Necropsy
Macroscopic examination was performed on all animals. The surviving animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthanimal 40%; Lot No.: 1609291-03, Expiry date: 31 October 2019, produced by: Alfasan International B.V., Kuipersweg 9, 3449 JA Woerden, The Netherlands; and Euthasol 400 mg/ml, Lot No.: 16B095, Expiry date: 31 January 2019, produced by: Produlab Pharma B.V., Forellenweg 16, 4941 SJ Raamsdonksveer, The Netherlands). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed.
Evaluation of the results
The method used was not intended to allow the calculation of a precise LD50 value. The test item was ranked into categories of Globally Harmonized Classification System (GHS (rev. 6) 2015). Clinical signs, body weight, body weight gain and gross macroscopic data were tabulated. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality (0/6) occurred at the dose level of 50 mg/kg bw.
2 out of 6 animals died on Day 2 and Day 3 at the dose level of 300 mg/kg bw.
5 out of 6 animals died between Day 1 and Day 7 at the dose level of 2000 mg/kg bw. - Clinical signs:
- other: All animals were symptom-free at the dose level of 50 mg/kg bw during the 14-day observation period. At the dose level of 300 mg/kg bw, the following test item related symptoms were observed up to Day 14 or until death: hunched back (6 out of 6 animals),
- Gross pathology:
- There was no evidence of the macroscopic observations in any animals at the dose level of 50 mg/kg bw.
At the dose level of 300 mg/kg bw, the following macroscopic findings were observed at necropsy: in the found dead animals, dark red discoloration/non-collapsed/collapsed lungs and thymus were agonal or post mortem rather than test item-related. Additionally, incidental thin fur at the right cheek was noted in one animal. There were test item-related gross changes noted in the liver and stomach of 3 out of 4 rats terminated on Day 14. Thickness of the non-glandular stomach mucosa and/or yellowish multifocal discoloration of the liver were seen in these animals. In addition, enlargement of pale discoloured spleen was macroscopically described in one single animal and therefore this change was not ascribed to the administration of test item.
At the dose level of 2000 mg/kg bw, the following macroscopic findings were observed at necropsy: for animal that died relatively soon after treatment (ID 1066), yellow liquid mixed with diet in the digestive content the stomach was observed. For animals that died later (ID 1063 and 1065), discoloration (dark red) of the stomach was observed in 1 out of the 2 animals (ID 1063). Other macroscopic changes including dark red discoloration of the non-collapsed/collapsed lungs and thymus were regarded as agonal or post mortem rather than test item-related. In one surviving animal multifocal thickness/yellow-red discoloration of the non-glandular stomach mucosa, red liquid mixed with diet in the digestive content of the stomach, yellowish multifocal discoloration of the liver and/or yellowish liquid (approximately 5.0 ml) within the abdominal cavity, were regarded as test item-related. - Other findings:
- FOUND DEAD - Macroscopic Findings
Dose level of 2000 mg/kg bw
For animal that died relatively soon after treatment (ID 1066), yellow liquid mixed with diet in the digestive content the stomach was observed. For animals that died later (ID 1063 and 1065), discoloration (dark red; yellow-red) of the stomach was observed.
Other macroscopic changes including dark red discoloration of the non-collapsed/collapsed lungs and thymus were regarded as agonal or post mortem rather than test item-related.
Dose level of 300 mg/kg bw
Dark red discoloration/non-collapsed/collapsed lungs and thymus were agonal or post mortem rather than test item-related. Additionally, incidental thin fur at the right cheek was noted in one animal. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Selenium Disulphide was found to be between 300 and 2000 mg/kg bw in female Crl:WI Wistar rats.
According the Regulation (EC) No 1272/2008 classification of Selenium Disulphide can be ranked as "Category 4" for acute oral exposure. - Executive summary:
The single-dose oral toxicity study with Selenium Disulphide was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris) in Crl:WI Wistar female rats.
Six groups of three female Crl:WI rats were treated with the test item at the dose levels of 300 (Group 1 and 2), 2000 (Group 3 and 4) and 50 mg/kg body weight (bw) (Group 5 and 6).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered at the dose levels of 50, 300 and 2000 mg/kg bw.
Initially, three females (Group 1) were treated at a dose level of 300 mg/kg bw. Due to delayed mortality with few or no clinical signs, the selection of dose groups based on mortality in the first 48 hours after dosing resulted in more groups being required than in a standard study.
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, 7 and before necropsy (Day 14) or at death. Additional measurements were performed on Day 4 in Group 2 and on Day 3 in Group 3. All animals were subjected to a necropsy and a macroscopic examination.
Mortality
No mortality (0/6) occurred at the dose level of 50 mg/kg bw.
2 out of 6 animals died on Day 2 and Day 3 at the dose level of 300 mg/kg bw.
5 out of 6 animals died between Day 1 and Day 7 at the dose level of 2000 mg/kg bw.
Clinical Observations
All animals were symptom-free at the dose level of 50 mg/kg bw during the 14-day observation period.
At the dose level of 300 mg/kg bw, the following test item related symptoms were observed up to Day 14 or until death: hunched back (6 out of 6 animals), piloerection (4 out of 6 animals), slight decreased activity (3 out of 6 animals), dark yellow coloured urine (3 out of 6 animals). 3 out of 6 animals were thin from Day 4 until the end of the 14-day observation period.
At the dose level of 2000 mg/kg bw, the following test item related symptoms were observed up to Day 14 or until death: hunched back (6 out of 6 animals), piloerection (3 out of 6 animals), slightly or moderately decreased activity (3 out of 6 animals) and dark yellow coloured urine (1 out of 6 animals). 3 out of 6 animals were thin from Day 5 or 6 until the end of the 14-day observation period or until death.
Body Weight and Body Weight Gain
At the dose level of 50 mg/kg bw, there were no treatment related body weight changes. Body weights were within the range commonly recorded for this strain and age.
At the dose level of 300 mg/kg bw, slight body weight loss was observed until Day 7 in 3 out of 6 animals. The body weight gain of the surviving animals were normal between Day 7 and Day 14.
At the dose level of 2000 mg/kg bw, slight or moderate body weight loss was observed in 2 out of 6 animals until Day 7 or until death. The body weight gain of the surviving animal was normal between Day 7 and Day 14.
Macroscopic Findings
There was no evidence of the macroscopic observations in any animals at the dose level of 50 mg/kg bw.
At the dose level of 300 mg/kg bw, the following macroscopic findings were observed at necropsy: in the found dead animals, dark red discoloration/non-collapsed/collapsed lungs and thymus were agonal or post mortem rather than test item-related. Additionally, incidental thin fur at the right cheek was noted in one animal. There were test item-related gross changes noted in the liver and stomach of 3 out of 4 rats terminated on Day 14. Thickness of the non-glandular stomach mucosa and/or yellowish multifocal discoloration of the liver were seen in these animals. In addition, enlargement of pale discoloured spleen was macroscopically described in one single animal and therefore this change was not ascribed to the administration of test item.
At the dose level of 2000 mg/kg bw, the following macroscopic findings were observed at necropsy: for animal that died relatively soon after treatment (ID 1066), yellow liquid mixed with diet in the digestive content the stomach was observed. For animals that died later (ID 1063 and 1065), discoloration (dark red) of the stomach was observed in 1 out of the 2 animals (ID 1063). Other macroscopic changes including dark red discoloration of the non-collapsed/collapsed lungs and thymus were regarded as agonal or post mortem rather than test item-related. In one surviving animal multifocal thickness/yellow-red discoloration of the non-glandular stomach mucosa, red liquid mixed with diet in the digestive content of the stomach, yellowish multifocal discoloration of the liver and/or yellowish liquid (approximately 5.0 ml) within the abdominal cavity, were regarded as test item-related.
Conclusion
Under the conditions of this study, the acute oral LD50 value of the test item Selenium Disulphide was found to be between 300 and 2000 mg/kg bw in female Crl:WI Wistar rats.
According the Regulation (EC) No 1272/2008 classification of Selenium Disulphide can be ranked as "Category 4" for acute oral exposure.
Reference
CLINICAL OBSERVATIONS
DOSE LEVEL: 300 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Observations |
Observation days |
Frequency |
|||||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||||
30' |
1h |
2h |
3h |
4h |
6h |
||||||||||||||||||
1 |
1057# |
Symptom Free |
+ |
+ |
+ |
- |
- |
+ |
+ |
|
5/7 |
||||||||||||
Hunched back |
- |
- |
- |
+ |
+ |
- |
- |
2/7 |
|||||||||||||||
Found dead |
- |
- |
- |
- |
- |
- |
- |
+ |
|
- |
|||||||||||||
1058# |
Symptom Free |
+ |
+ |
+ |
- |
- |
+ |
+ |
+ |
|
6/8 |
||||||||||||
Hunched back |
- |
- |
- |
+ |
+ |
- |
- |
- |
2/8 |
||||||||||||||
Found dead |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
|
- |
||||||||||||
1059 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/20 |
|
Hunched back |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/20 |
||
Piloerection |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
4/20 |
||
2 |
1060 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
7/20 |
Activity decreased |
- |
- |
- |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/20 |
||
Hunched back |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
13/20 |
||
Piloerection |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
13/20 |
||
Wasted |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
11/20 |
||
Urine coloured - dark yellow |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
6/20 |
||
1061 |
Symptom Free |
+ |
+ |
+ |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
5/20 |
|
Activity decreased |
- |
- |
- |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/20 |
||
Hunched back |
- |
- |
- |
+ |
+ |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
15/20 |
||
Piloerection |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
13/20 |
||
Wasted |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
- |
- |
9/20 |
||
Urine coloured - dark yellow |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
6/20 |
||
1062 |
Symptom Free |
+ |
+ |
+ |
- |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
4/20 |
|
Activity decreased |
- |
- |
- |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1/20 |
||
Hunched back |
- |
- |
- |
+ |
+ |
+ |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/20 |
||
Piloerection |
- |
- |
- |
- |
- |
- |
- |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
9/20 |
||
Wasted |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
11/20 |
||
Urine coloured - dark yellow |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
6/20 |
Remarks:
+ = present h = hour (s)
# = Found dead
- = absent ' = minute
Frequency of observation = number of occurrence of observation / total number of observations Severities: 1 = Slight/Small/Few; 2 = Moderate/Medium; 3 = Marked/Large/Many
CLINICAL OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Observations |
Observation days |
Frequency |
|||||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||||
30' |
1h |
2h |
3h |
4h |
6h |
||||||||||||||||||
3 |
1063# |
Symptom Free |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
|
4/12 |
|||||||
Activity decreased |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
2 |
5/12 |
||||||||||
Hunched back |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
8/12 |
||||||||||
Piloerection |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
6/12 |
||||||||||
Wasted |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
2/12 |
||||||||||
Found dead |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
|
- |
||||||||
1064 |
Symptom Free |
+ |
+ |
+ |
- |
- |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
6/20 |
|
Activity decreased |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
6/20 |
||
Hunched back |
- |
- |
- |
+ |
+ |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
14/20 |
||
Piloerection |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
12/20 |
||
Wasted |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
9/20 |
||
Urine coloured - dark yellow |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
7/20 |
||
1065# |
Symptom Free |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
|
4/11 |
|||||||||
Activity decreased |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
4/11 |
|||||||||||
Hunched back |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
7/11 |
|||||||||||
Piloerection |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
5/11 |
|||||||||||
Wasted |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
1/11 |
|||||||||||
Found dead |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
+ |
|
- |
|||||||||
4 |
1066# |
Symptom Free |
+ |
+ |
- |
- |
- |
- |
|
2/6 |
|||||||||||||
Hunched back |
- |
- |
+ |
+ |
+ |
+ |
4/6 |
||||||||||||||||
Found dead |
- |
- |
- |
- |
- |
- |
+ |
|
- |
||||||||||||||
1067# |
Symptom Free |
+ |
+ |
+ |
- |
- |
- |
- |
|
3/7 |
|||||||||||||
Hunched back |
- |
- |
- |
+ |
+ |
+ |
+ |
4/7 |
|||||||||||||||
Found dead |
- |
- |
- |
- |
- |
- |
- |
+ |
|
- |
|||||||||||||
1068# |
Symptom Free |
+ |
+ |
+ |
- |
- |
- |
- |
|
3/7 |
|||||||||||||
Hunched back |
- |
- |
- |
+ |
+ |
+ |
+ |
4/7 |
|||||||||||||||
Found dead |
- |
- |
- |
- |
- |
- |
- |
+ |
|
- |
CLINICAL OBSERVATIONS
DOSE LEVEL: 50 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Observations |
Observation days |
Frequency |
|||||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||||
30' |
1h |
2h |
3h |
4h |
6h |
||||||||||||||||||
5 |
1098 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
1099 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
1100 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
6 |
1101 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
1102 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
1103 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
Remarks:
+ = present h = hour (s)
' = minute
Frequency of observation = number of occurrence of observation / total number of observations
BODY WEIGHT DATA
DOSE LEVEL: 300 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Body weight (g) Days |
Day/Body Weight(g) Death |
Body Weight Gain (g) |
|||||||
-1 |
0 |
4 |
7 |
14 |
-1-0 |
0-7 |
7- 14 |
-1 - 14 |
|||
|
1057# |
214 |
196 |
/ |
- |
- |
2/202 |
-18 |
- |
- |
- |
1 |
1058# |
207 |
193 |
/ |
- |
- |
3/190 |
-14 |
- |
- |
- |
|
1059 |
212 |
193 |
/ |
202 |
231 |
- |
-19 |
9 |
29 |
19 |
|
1060 |
200 |
187 |
162 |
159 |
170 |
- |
-13 |
-28 |
11 |
-30 |
2 |
1061 |
194 |
186 |
167 |
160 |
183 |
- |
-8 |
-26 |
23 |
-11 |
|
1062 |
203 |
196 |
172 |
160 |
171 |
- |
-7 |
-36 |
11 |
-32 |
Mean: |
205.0 |
191.8 |
167.0 |
170.3 |
188.8 |
- |
-13.2 |
-20.3 |
18.5 |
-13.5 |
|
Standard deviation: |
7.5 |
4.4 |
5.0 |
21.2 |
28.8 |
- |
5.0 |
20.0 |
9.0 |
23.6 |
BODY WEIGHT DATA
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Body weight (g) Days |
Day/Body Weight (g) Death |
Body Weight Gain (g) |
|||||||
-1 |
0 |
3 |
7 |
14 |
-1-0 |
0-7 |
7- 14 |
-1 - 14 |
|||
|
1063# |
211 |
197 |
180 |
153 |
- |
7/153 |
-14 |
-44 |
- |
- |
3 |
1064 |
214 |
197 |
183 |
178 |
181 |
|
-17 |
-19 |
3 |
-33 |
|
1065# |
209 |
196 |
178 |
- |
- |
6/168 |
-13 |
- |
- |
- |
|
1066# |
195 |
198 |
/ |
- |
- |
1/184 |
3 |
- |
- |
- |
4 |
1067# |
207 |
189 |
/ |
- |
- |
2/195 |
-18 |
- |
- |
- |
|
1068# |
202 |
196 |
/ |
- |
- |
2/186 |
-6 |
- |
- |
- |
Mean: |
206.3 |
195.5 |
180.3 |
165.5 |
181.0 |
- |
-10.8 |
-31.5 |
3.0 |
-33.0 |
|
Standard deviation: |
6.9 |
3.3 |
2.5 |
17.7 |
- |
- |
8.0 |
17.7 |
- |
- |
Remarks
- = No data
# = Found dead
/ = No body weight measurement was performed
BODY WEIGHT DATA
DOSE LEVEL: 50 mg/kg bw, Treatment on Day 0
SEX: FEMALE
CageNo. |
Animal Number |
Body weight (g) Days |
Day/Body Weight (g) Death |
Body Weight Gain (g) |
|||||||
-1 |
0 |
|
7 |
14 |
-1-0 |
0-7 |
7- 14 |
-1 - 14 |
|||
|
1098 |
240 |
230 |
/ |
253 |
263 |
- |
-10 |
23 |
10 |
23 |
5 |
1099 |
223 |
214 |
/ |
234 |
246 |
- |
-9 |
20 |
12 |
23 |
|
1100 |
254 |
240 |
/ |
261 |
290 |
- |
-14 |
21 |
29 |
36 |
|
1101 |
240 |
219 |
/ |
257 |
268 |
- |
-21 |
38 |
11 |
28 |
6 |
1102 |
232 |
220 |
/ |
245 |
255 |
- |
-12 |
25 |
10 |
23 |
|
1103 |
233 |
223 |
/ |
241 |
248 |
- |
-10 |
18 |
7 |
15 |
Mean: |
237.0 |
224.3 |
/ |
248.5 |
261.7 |
- |
-12.7 |
24.2 |
13.2 |
24.7 |
|
Standard deviation: |
10.4 |
9.3 |
/ |
10.3 |
16.3 |
- |
4.5 |
7.2 |
7.9 |
6.9 |
Remarks
- = No data
/ = No body weight measurement was performed
NECROPSY FINDINGS
DOSE LEVEL: 300 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
1057# |
21 September 2017 Day 2 |
No external observations recorded |
Collapsed |
Lungs |
1058# |
22 September 2017 Day 3 |
Fur: Thin, cheek, right |
Non-collapsed |
Lungs |
|
Discoloration, dark red, diffuse, all lobes |
|||||
Discoloration, dark red, diffuse |
Thymus |
||||
1059 |
03 October 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
2 |
1060 |
04 October 2017 Day 14 |
No external observations recorded |
Discoloration, yellowish, multifocal, all lobes |
Liver |
1061 |
04 October 2017 Day 14 |
No external observations recorded |
Discoloration, yellowish, multifocal, all lobes |
Liver |
|
Enlargement |
Spleen |
||||
Discoloration, pale, diffuse |
|||||
Thickness, multifocal, non-glandular mucosa |
Stomach |
||||
1062 |
04 October 2017 Day 14 |
No external observations recorded |
Discoloration, yellowish, multifocal, all lobes |
Liver |
|
Thickness, multifocal, non-glandular mucosa |
Stomach |
Remarks
# = Found dead
NECROPSY FINDINGS
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/Tissue |
3 |
1063# |
28 September 2017 Day 7 |
No external observations recorded |
Non-collapsed |
Lungs |
Discoloration, dark red, diffuse, all lobes |
|||||
Discoloration, dark red, diffuse |
Thymus |
||||
Discoloration, dark red, multifocal, non- glandular mucosa |
Stomach |
||||
1064 |
05 October 2017 Day 14 |
No external observations recorded |
Liquid material yellowish approx.: 5 ml |
Abdominal Cavity |
|
Discoloration, yellowish, multifocal, all lobes |
Liver |
||||
Thickness, multifocal, non-glandular mucosa |
Stomach |
||||
Discoloration, yellow-red, focal approx.: 30 mm x 10 mm insize non-glandular mucosa |
|||||
Digestive content: Liquid material red mixed with diet |
|||||
1065# |
27 September 2017 Day 6 |
No external observations recorded |
Collapsed |
Lungs |
|
Discoloration, red, diffuse, all lobes |
|||||
4 |
1066# |
23 September 2017 Day 1 |
No external observations recorded |
Non-collapsed |
Lungs |
Digestive content: Material liquid yellow mixed with diet |
Stomach |
||||
1067# |
24 September 2017 Day 2 |
No external observations recorded |
Non-collapsed |
Lungs |
|
1068# |
24 September 2017 Day 2 |
No external observations recorded |
Non-collapsed |
Lungs |
|
Discoloration, red, diffuse, all lobes |
Remarks
# = Found dead
NECROPSY FINDINGS
DOSE LEVEL: 50 mg/kg bw, Treatment on Day 0
SEX: FEMALE
Cage No. |
Animal Number |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/Tissue |
5 |
1098 |
18 October 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
1099 |
18 October 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
1100 |
18 October 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
6 |
1101 |
24 October 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
1102 |
24 October 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
1103 |
24 October 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- K1 - Study performed in GLP accredited laboratory to recognised OECD and EU standards.
Additional information
Acute Toxicity via Oral Route
Six groups of three female Crl:WI rats were treated with a single oral dose of selenium disulphide at the dose levels of 50, 300, 2000 mg/kg body weight
(bw) and observed for 14 days.
Mortality
No mortality (0/6) occurred at the dose level of 50 mg/kg bw.
2 out of 6 animals died on Day 2 and Day 3 at the dose level of 300 mg/kg bw.
5 out of 6 animals died between Day 1 and Day 7 at the dose level of 2000 mg/kg bw.
Clinical Observations
All animals were symptom-free at the dose level of 50 mg/kg bw during the 14-day observation period.
At the dose level of 300 mg/kg bw, the following test item related symptoms were observed up to Day 14 or until death: hunched back (6 out of 6 animals),
piloerection (4 out of 6 animals), slight decreased activity (3 out of 6 animals), dark yellow coloured urine (3 out of 6 animals). 3 out of 6 animals were thin from Day 4 until the end of the 14-day observation period.
At the dose level of 2000 mg/kg bw, the following test item related symptoms were observed up to Day 14 or until death: hunched back (6 out of 6 animals),
piloerection (3 out of 6 animals), slightly or moderately decreased activity (3 out of 6 animals) and dark yellow coloured urine (1 out of 6 animals). 3 out of 6 animals were thin from Day 5 or 6 until the end of the 14-day observation period or until death.
Body Weight and Body Weight Gain
At the dose level of 50 mg/kg bw, there were no treatment related body weight changes. Body weights were within the range commonly recorded for this
strain and age.
At the dose level of 300 mg/kg bw, slight body weight loss was observed until Day 7 in 3 out of 6 animals. The body weight gain of the surviving animals
were normal between Day 7 and Day 14.
At the dose level of 2000 mg/kg bw, slight or moderate body weight loss was observed in 2 out of 6 animals until Day 7 or until death. The body weight gain
of the surviving animal was normal between Day 7 and Day 14.
Macroscopic Findings
There was no evidence of the macroscopic observations in any animals at the dose level of 50 mg/kg bw.
At the dose level of 300 mg/kg bw, the following macroscopic findings were observed at necropsy: in the found dead animals, dark red discoloration /non-collapsed/collapsed lungs and thymus were agonal or post mortem rather than test item-related. Additionally, incidental thin fur at the right cheek was noted in one animal. There were test item-related gross changes noted in the liver and stomach of 3 out of 4 rats terminated on Day 14. Thickness of the non-glandular stomach mucosa and/or yellowish multifocal discoloration of the liver were seen in these animals. In addition, enlargement of pale discoloured spleen was macroscopically described in one single animal and therefore this change was not ascribed to the administration of test item.
At the dose level of 2000 mg/kg bw, the following macroscopic findings were observed at necropsy: for animal that died relatively soon after treatment (ID
1066), yellow liquid mixed with diet in the digestive content the stomach was observed. For animals that died later (ID 1063 and 1065), discoloration (dark red) of the stomach was observed in 1 out of the 2 animals (ID 1063). Other macroscopic changes including dark red discoloration of the non-collapsed/collapsed lungs and thymus were regarded as agonal or post mortem rather than test item-related. In one surviving animal multifocal thickness/yellow-red discoloration of the non-glandular stomach mucosa, red liquid mixed with diet in the digestive content of the stomach, yellowish multifocal discoloration of the liver and/or yellowish liquid (approximately 5.0 ml) within the abdominal cavity, were regarded as test item-related.
Justification for classification or non-classification
Acute Toxicity via Oral Route
According to the OECD 423 test guideline, the oral LD50 value of selenium disulphide in Wistar rats was established established to be between 300 - 2000 mg/kg bw.
Based on these results, selenium disulphide is classified as "Category 4" according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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