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EC number: 219-455-3 | CAS number: 2439-01-2
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3rd April 1990 to 25th April 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, Guideline on Toxicology Study Data for Application of Agricultural Chemical Registration, 59 Nohsan No. 4200, January 1985.
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- TEST SUBSTANCE INFORMATION:
- Identification in report: Technical grade MORESTAN
- Chemical name: 6-Methyl-1,3-dithiolo[4,5-b]quinoxalin-2-one
-CAS Registry No.: 2439-01-2
- Physical apprearnce: Yellow granules
SOURCE OF TEST MATERIAL
- Source of test material: Mobay Corporation, Agricultural Chemicals Division, Box 4913, Hawthorn Road, Kansas City, Missouri 64120-0013
- Lot No. of test material: 203930103
- Expiration date of the lot: Not reported
- Purity: 94.2% (purity test date not reported)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Freezer
- Stability under test conditions: Unknown at room temperature
- Solubility and stability of the test substance in the vehicle: Not testsed as all doses were prepared just prior to administration, assumed stable for the duration of the test
- Reactivity of the test substance with the vehicle: None
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, all doses prepared on the day of administration
- Final dilution of a dissolved solid, stock liquid or gel: Test concentrations: 1630, 2520 and 3680 mg/kg in males and 968, 1630, 2520 and 3680 mg/kg in females
FORM AS APPLIED IN THE TEST (if different from that of starting material) Test substance applied as a solution in 2%(v/v) Cremophor EL in deionised water (10ml/kg) - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sasco, Inc., Houston, Texas
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 223-281g (20 males), 187-218g (15 males). All bodyweigt ranges on day 0 were within 20% of the mean bodyweights for each sex.
- Fasting period before study: Fasted overnight prior to dosing
- Housing: Individually in stainless steel cages suspended over a deotized animal cage board (DACB) bedding. Bedding changed a minimum of three times a week with new cages every three weeks. Room disinfected at least once every three weeks.
- Diet available ad libitum
- Water availabale ad libitum
- Acclimation period: At least six days prior to study initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 40-70
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: To: From: 3rd April 1990 (Release of animal shipment for study use) to 25th April 1990 (Terminal sacrifice date) - Route of administration:
- oral: gavage
- Vehicle:
- other: 2% (v/v) Cremophor EL in deionized water (10 ml/kg)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Analytically confirmed doses of 1630, 2520 and 3680 mg/kg in males and 968, 1630, 2520 and 3680 mg/kg in females
- Amount of vehicle (if gavage): Administered at 10 ml/kg by gavage
- Justification for choice of vehicle: Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
- Doses:
- Nominal doses of 1500, 2250 and 3375 mg/kg in males and 1000, 1500, 2250 and 3375 mg/kg in females. Analytically confirmed as doses of 1630, 2520 and 3680 mg/kg in males and 968, 1630, 2520 and 3680 mg/kg in females.
- No. of animals per sex per dose:
- Five animals per sex/dose. 35 Animals in total for study use.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Five (young adult) Sprague-Dawley rats per sex/dose were observed for 14-days post dose for mortality and clinical signs with observations performed twice daily (once at weekends). Bodyweight were recorded on Day 0, 7 and 14. Observations were performed twice daily (once at weekends).
- Gross necropsy of survivors performed: yes
- Other examinations performed: Gross pathological examination was performed on all animals as soon as practicable after death. Suirviving animals after 14-days were asphixiated by CO2 before gross pathological examination was performed. - Statistics:
- LD50 values, 95% confidence intervals and the slope of the dose mortality curve were calculated by modified probit analysis computer program (1982: Stephen, C.E.)
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 541 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 095 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The incidence of mortality increased with dose for males and females with all deaths 1-4 days post dose for both sexes.
Males: 1/5 at 1630 mg/kg /bw
1/5 at 2520 mg/kg /bw
5/5 at 3680 mg/kg /bw
Females: 2/5 at 968 mg/kg /bw
4/5 at 1630 mg/kg /bw
5/5 at 2520 mg/kg /bw
5/5 at 3680 mg/kg /bw - Clinical signs:
- Clinical signs presented in table below.
- Body weight:
- Surviving males bodyweight gain decreased from days 0-7 in a dose related manner, recovery was evident from days 7-14.
Body weight gain was not effected in surviving females - Gross pathology:
- Other findings:
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral toxicity of MORESTAN in young adult Sprague-Dawley rats was tested using analytically-confirmed doses of 1630, 2520 and 3680 mg/kg in males and 968, 1630, 2520 and 3680 mg/kg in females (5 animals/sex/dose). Treatment related signs of toxicity were observed (and with the exception of Alopecia) were resolved in surviving animals by day 7. For all surviving males a dose-dependent reduction in body weight gain was observed from day 0-7 which recovery between days 7-14. This effect was not observed in surviving females. Evidence of treatment-related gross lesions were observed in animals found dead, with one low dose male and female showing gross lesions which survided to day 14.
The acute oral LD50 (with 95% confidence limits) was 2541 mg/kg (1592 to 4070 mg/kg) for males. For females the acute oral LD50 was 1095 mg/kg.
The no-observed-effect level for MORESTAN was <1630 mg/kg for males and <968 mg/kg for females.
Reference
Clinical signs |
Male: dose (mg/kg) |
Female: dose (mg/kg) |
|||||
|
1630 |
2520 |
3680 |
968 |
1630 |
2520 |
3680 |
Decreased motor activity |
2 |
|
2 |
2 |
4 |
4 |
2 |
Tremors |
|
|
|
|
2 |
2 |
1 |
Red nasal stain |
4 |
4 |
5 |
4 |
5 |
4 |
1 |
Hunched posture |
1 |
1 |
4 |
|
|
4 |
2 |
Yellow perianal stain |
2 |
2 |
5 |
1 |
2 |
4 |
3 |
Yellow urine stain |
2 |
|
2 |
2 |
3 |
2 |
2 |
Red stain on both forepaws |
|
1 |
2 |
2 |
2 |
3 |
1 |
Red lacrimal stain |
1 |
1 |
|
1 |
2 |
1 |
1 |
Red stain on forehead |
|
|
1 |
1 |
2 |
1 |
1 |
Yellow oral stain |
1 |
|
2 |
|
|
|
1 |
Alopecia on ventrum |
2 |
|
|
|
|
|
|
Alopecia with red spots on both forepaws |
|
1 |
|
|
|
|
|
Alopecia on both forepaws |
|
1 |
|
|
|
|
|
Non-dose related signs included Diarrhea (1 male at 3680 mg/kg bw) and clear lacrimation (2 females at 3680 mg/kg/ bw)
|
Males |
||||
Dose (mg/kg) |
1630 |
2520 |
|
3680 |
|
|
4/5 Sacrificed |
1/5 Found dead |
4/5 |
1/5 Found dead |
5/5 |
No gross lesions |
2 |
|
3 |
|
|
Nasal stain |
|
|
|
|
4 |
salivation |
|
1 |
|
|
3 |
Ventrum/anal/perineal stain |
|
1 |
|
|
3 |
Duodenum ulcers/dark zones |
1 |
1 |
|
1 |
5 |
Discolouration/ ulcers/ zones Stomach, glandular mucosa |
|
|
|
1 |
4 |
Abdominal fluid/exudate |
|
1 |
|
|
1 |
Alopecia |
2 |
|
1 |
|
|
|
Females |
|
||||
Dose (mg/kg) |
968 |
1630 |
2520 |
3680 |
||
|
3/5 Sacrificed |
2/5 Found dead |
1/5 |
4/5 Found dead |
5/5 |
5/5 Found dead |
No gross lesions |
2 |
|
1 |
|
|
|
Nasal stain |
|
2 |
|
|
3 |
1 |
Anal/perineal stain |
|
2 |
|
2 |
4 |
|
Ocular stain/discharge |
|
1 |
|
|
1 |
2 |
Duodenal ulcers/depressed/ |
1 |
2 |
|
4 |
5 |
5 |
Discolouration/ulcers/zones Stomach, glandular mucosa |
|
2 |
|
1 |
2 |
5 |
Abdominal fluid/exudate |
|
|
|
1 |
|
|
Salivation |
|
|
|
|
1 |
1 |
Fluid-filled small intestines |
|
1 |
|
|
|
|
Ruptured vessel by adrenal |
|
|
|
1 |
|
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 095 mg/kg bw
- Quality of whole database:
- Klimisch 1
Additional information
Justification for classification or non-classification
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.
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