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EC number: 219-203-2 | CAS number: 2386-57-4
- 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 oral toxicity
The single-dose oral toxicity study with Sodium methanesulfonate 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 rats.
Two groups of three female Crl:WI rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2). 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 level of 2000 mg/kg body weight (equivalent to 4.23 mL/kg bw of SPS10LS). Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) 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. 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). All animals were subjected to a necropsy and a macroscopic examination.
Sodium methanesulfonate did not cause mortality at a dose level of 2000 mg/kg bw. All animals were symptom free during the study. Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect. There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Under the conditions of this study, the acute oral LD0 value of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in female Crl:WI rats.
Acute dermal toxicity
An acute dermal toxicity study was performed with test item Sodium methanesulfonate in Crl:WI rats, in compliance with OECD Guideline No.: 402. A limit test was carried out at 2000 mg Sodium methanesulfonate/kg body weight (equivalent to 4.23 mL/kg bw of SPS10LS) in both sexes (5 rats/sex). The test item was applied 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 7 and 14. Gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14).
Sodium methanesulfonate did not cause mortality at the dose level of 2000 mg/kg bw. There were no systemic clinical signs noted in any animal throughout the study. No local dermal signs were observed after treatment with the test item during the 14 days observation period. Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect.There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Under the conditions of this study, the acute dermal lethal dose (LD0 value) of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in male and female Crl:WI rats.
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:
- 28 July 2016 to 12 August 2016
- 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)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 423. Acute Oral Toxicity – Acute Toxic Class Method. Adopted: 17 December 2001
- Deviations:
- yes
- Remarks:
- see "Any other information" for details
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class 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 Wistar rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
Hygienic level at arrival: 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, 8 weeks old
Body weight at treatment: 186 – 190 g
Acclimatization period: 7-8 days
HusbandryAnimal health: Only healthy animals were used for the test. The health status was certified by the staff Veterinarian.Number of animal room: 245/4
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: 19.7 – 24.7 °C
Relative humidity: 31 - 77%
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: 278 5652, expiry date: 31 October 2016), ad libitum, and tap water from the municipal supply, as for human consumption from a 500 ml bottle, ad libitum.
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 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:
- unchanged (no vehicle)
- Details on oral exposure:
- The test item was administered as a single dose without using any vehicle.Justification of the dose:The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose (equivalent to 4.23 mL/kg bw of SPS10LS, based on the analytics performed on 27 May 2016).Initially, three female animals were treated with 2000 mg/kg bw of the test item. No mortality was observed, therefore further 3 animals were treated at the dose level of 2000 mg/kg bw. As no mortality was observed in this second dose group, further testing was not required according to the test guidelines (OECD 423, Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris).
- Doses:
- A single oral treatment was carried out by gavage for each animal. The test item was administered at the dose level of 2000 mg/kg body weight (equivalent to 4.23 mL/kg bw of SPS10LS).
- No. of animals per sex per dose:
- Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. A confirmatory group of three females (Group 2) was treated at the same dose level.
- Control animals:
- no
- Details on study design:
- 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 just before treatment. The test item was administered by oral gavage in the morning. The food was returned 3 hours after the treatment.
OBSERVATIONS
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. 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) and weekly Thereafter.
NECROPSY
Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthanimal 40%; Lot No.: 1409236-06, Expiry Date: September 2017, Produced by: AlfasanNederland BV, Woerden, Netherlands). 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. - Statistics:
- Not specified
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Sodium methanesulfonate did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- All animals were symptom free during the study.
- Body weight:
- Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect.
- Gross pathology:
- There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
- Other findings:
- No further findings specified in the study report.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD0 value of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in female Crl:WI rats.
- Executive summary:
The single-dose oral toxicity study with Sodium methanesulfonate 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 rats.
Two groups of three female Crl:WI rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2). 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 level of 2000 mg/kg body weight (equivalent to 4.23 mL/kg bw of SPS10LS). Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) 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. 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). All animals were subjected to a necropsy and a macroscopic examination.
Sodium methanesulfonate did not cause mortality at a dose level of 2000 mg/kg bw. All animals were symptom free during the study. Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect. There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Under the conditions of this study, the acute oral LD0 value of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in female Crl:WI rats.
Reference
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 |
7-14 |
|||||||||
30’ |
1h |
2h |
3h |
4h |
6h |
|||||||||||
1 |
1945 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
1946 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
1947 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
2 |
1948 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
1949 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
1950 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
Remarks:
+ = present
h = hour ‘ = minute
Frequency of observation = number of occurrence of observation/ total number of observations
BODY WEIGHT DATA
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0 SEX: Female
Cage No. |
Animal Number |
Body Weight (g) Days |
Body Weight Gain (g) |
||||||
-1 |
0 |
7 |
14 |
-1 – 0 |
0 – 7 |
7 – 14 |
-1 – 14 |
||
1 |
1945 |
200 |
186 |
228 |
248 |
-14 |
42 |
20 |
48 |
1946 |
204 |
190 |
228 |
253 |
-14 |
38 |
25 |
49 |
|
1947 |
203 |
189 |
225 |
251 |
-14 |
36 |
26 |
48 |
|
2 |
1948 |
197 |
187 |
222 |
242 |
-10 |
25 |
20 |
45 |
1949 |
203 |
188 |
240 |
255 |
-15 |
52 |
15 |
52 |
|
1950 |
205 |
190 |
235 |
239 |
-15 |
45 |
4 |
34 |
|
Mean: |
202.0 |
188.3 |
229.7 |
248.0 |
-13.7 |
41.3 |
18.3 |
46.0 |
|
Standard deviation: |
3.0 |
1.6 |
6.7 |
6.3 |
1.9 |
6.4 |
8.1 |
6.3 |
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 |
1 |
1945 |
11 August 2016 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
1946 |
11 August 2016 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
1947 |
11 August 2016 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
2 |
1948 |
12 August 2016 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
1949 |
12 August 2016 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
1950 |
12 August 2016 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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:
- 19 July 2016 to 02 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 402. Acute Oral Toxicity – Acute Toxic Class Method. Adopted: 24 February 1987
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/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
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Number of animals: 5 animals/sex
Sex: Male and female, female rats were nulliparous and non-pregnant
Age of animals at dosing: Young healthy adult rats
Body weight at treatment: Between 217 g and 250 g
Acclimatization period: 5 days
HusbandryAnimal health: Only healthy animals were used for the test. The health status was certified by the staff Veterinarian.Number of animal room: 245/9
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: “Lignocel 3/4-S Hygienic Animal Bedding” and “Arbocel crinklets natural” nest building material 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: 20.8 – 24.8 °C
Relative humidity: 35 – 80%
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 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 No.: 278 5652, expiry date: 30 November 2016), ad libitum, and tap water from the municipal supply, as for human consumption from a 500 ml bottle, ad libitum.
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 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. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- 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 to the shaved skin and remained in contact with the skin for the 24-hour exposure period. 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 using 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.
- Duration of exposure:
- 24 hours
- Doses:
- Doses
Justification of the doses:The test item was not expected to be lethal at 2000 mg/kg body weight (bw). A limit test was therefore performed at 2000 mg Sodium methanesulfonate /kg bw (equivalent to 4.23 mL/kg bw of SPS10LS, based on the analytics performed on 27 May 2016).A single dermal application was made and was followed by a 14-day observation period. - No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- 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.
Skin Irritation:Adverse skin reactions at the site of application were recorded daily following the removal of the dressing.
Body Weight Measurement: The body weights were recorded on Day 0 (before test item administration) and on Days 7 and 14 just before necropsy.
NECROPSY
Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthanimal 40%; Lot No.: 1409236-06, Expiry Date: September 2017, Produced by: AlfasanNederland BV, Woerden, Netherlands). 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. - Statistics:
- Not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Sodium methanesulfonate did not cause mortality at the dose level of 2000 mg/kg bw.
- Clinical signs:
- There were no systemic clinical signs noted in any animal throughout the study.
- Body weight:
- Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect.
- Gross pathology:
- There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
- Other findings:
- No further findings specified in the study report.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal lethal dose (LD0 value) of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in male and female Crl:WI rats
- Executive summary:
An acute dermal toxicity study was performed with test item Sodium methanesulfonate in Crl:WI rats, in compliance with OECD Guideline No.: 402. A limit test was carried out at 2000 mg Sodium methanesulfonate/kg body weight (equivalent to 4.23 mL/kg bw of SPS10LS) in both sexes (5 rats/sex). The test item was applied 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 7 and 14. Gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14).
Sodium methanesulfonate did not cause mortality at the dose level of 2000 mg/kg bw. There were no systemic clinical signs noted in any animal throughout the study. No local dermal signs were observed after treatment with the test item during the 14 days observation period. Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect.There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Under the conditions of this study, the acute dermal lethal dose (LD0 value) of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in male and female Crl:WI rats.
Reference
CLINICAL OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEX: Male |
|||
Cage No. |
Animal No. |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
1 |
1777 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
2 |
1778 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
3 |
1779 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
4 |
1780 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
5 |
1781 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DOSE LEVEL: 2000 mg/kg bw |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEX: Female |
|||
Cage No. |
Animal No. |
Observations |
Observations days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
6 |
1782 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
7 |
1783 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
8 |
1784 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
9 |
1785 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
10 |
1786 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remarks: |
+ = present |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
h = hour (s) |
|
Treatment day = Day 0 |
|
|
|
|
|
|
|
|
|||||||
|
|
Frequency of observation = number of occurrence of observation / total number of observations |
|
BODY WEIGHT DATA
DOSE LEVEL: 2000 mg/kg bw |
|
|
SEX: Male |
||||
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
||
1 |
1777 |
235 |
299 |
363 |
64 |
64 |
128 |
2 |
1778 |
217 |
277 |
324 |
60 |
47 |
107 |
3 |
1779 |
244 |
304 |
364 |
60 |
60 |
120 |
4 |
1780 |
245 |
306 |
358 |
61 |
52 |
113 |
5 |
1781 |
250 |
318 |
377 |
68 |
59 |
127 |
Mean: |
238.2 |
300.8 |
357.2 |
62.6 |
56.4 |
119.0 |
|
Standard deviation: |
13.0 |
15.0 |
19.8 |
3.4 |
6.8 |
9.0 |
|
|
|
|
|
|
|
|
|
DOSE LEVEL: 2000 mg/kg bw |
|
|
SEX: Female |
||||
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
||
6 |
1782 |
224 |
227 |
242 |
3 |
15 |
18 |
7 |
1783 |
218 |
256 |
275 |
38 |
19 |
57 |
8 |
1784 |
226 |
241 |
258 |
15 |
17 |
32 |
9 |
1785 |
220 |
245 |
266 |
25 |
21 |
46 |
10 |
1786 |
231 |
259 |
271 |
28 |
12 |
40 |
Mean: |
223.8 |
245.6 |
262.4 |
21.8 |
16.8 |
38.6 |
|
Standard deviation: |
5.1 |
12.8 |
13.0 |
13.3 |
3.5 |
14.7 |
NECROPSY FINDINGS
DOSE LEVEL: 2000 mg/kg bw |
|
|
SEX: Male |
||
Cage No. |
Animal No. |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
1777 |
02 August 2016 Day 14 |
No external observations |
No internal observations |
Not applicable |
2 |
1778 |
02 August 2016 Day 14 |
No external observations |
No internal observations |
Not applicable |
3 |
1779 |
02 August 2016 Day 14 |
No external observations |
No internal observations |
Not applicable |
4 |
1780 |
02 August 2016 Day 14 |
No external observations |
No internal observations |
Not applicable |
5 |
1781 |
02 August 2016 Day 14 |
No external observations |
No internal observations |
Not applicable |
|
|
|
|
|
|
DOSE LEVEL: 2000 mg/kg bw |
|
|
SEX: Female |
||
Cage No. |
Animal No. |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/Tissue |
6 |
1782 |
02 August 2016 Day 14 |
No external observations |
No external observations |
Not applicable |
7 |
1783 |
02 August 2016 Day 14 |
No external observations |
No external observations |
Not applicable |
8 |
1784 |
02 August 2016 Day 14 |
No external observations |
No external observations |
Not applicable |
9 |
1785 |
02 August 2016 Day 14 |
No external observations |
No external observations |
Not applicable |
10 |
1786 |
02 August 2016 Day 14 |
No external observations |
No external observations |
Not applicable |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
No classification is warranted.
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