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EC number: 245-044-3 | CAS number: 22504-50-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 May 2022 - 18 May 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Ethylene bis(3-mercaptopropionate)
- EC Number:
- 245-044-3
- EC Name:
- Ethylene bis(3-mercaptopropionate)
- Cas Number:
- 22504-50-3
- Molecular formula:
- C8H14O4S2
- IUPAC Name:
- 2-[(3-sulfanylpropanoyl)oxy]ethyl 3-sulfanylpropanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok tere 4B
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8-9 weeks old
- Weight at study initiation: 178-193 g. The maximum difference of individual animal weights from the mean of the treatment group did not exceed 20%.
- Fasting period before study: yes, over night
- Housing: 3 animals/cage
- Diet (e.g. ad libitum): standard laboratory rat diet, ad libitum (SM Rat/Mouse, Breeding & Maintenance, ssniff Spezialdiäten GmbH (D-59494 Soest, Germany))
- Water (e.g. ad libitum): ap water from the municipal supply, ad libitum
- Acclimation period: At least 13 days
- Microbiological status when known: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25 °C (target: 22 ± 3 °C)
- Humidity (%): 31 – 71 % (target: 30 – 70 %)
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.
CLASS METHOD
- Rationale for the selection of the starting dose:
According to the guideline, the starting dose level should be that which is most likely to produce mortality in some of the dosed animals. As starting dose level for acute toxicity study, a dose of 300 mg/kg body weight (bw) was selected based on the information, provided by the Supplier, which indicate that the LD50 value of the test item is between 50 and 300 mg/kg bw. - Doses:
- 300, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at least once during the first 30 minutes, at 1, 2, 3, 4 and 6 hours after the treatment and once daily for 14 consecutive days thereafter
- Frequency of weighing: days 0 (prior to dosing), 7 and 14 (prior to necropsy), terminal body weight of animals found dead was also recorded
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the dose level of 2000 mg/kg bw, 2/3 animals were found dead on Day 0 and 1/3 on Day 1.
At the dose level of 300 mg/kg bw, one animal (out of 6) was found dead on Day 6, five animals survived. - Clinical signs:
- other: 300 mg/kg bw: decreased activity, hunched back and irritability; 2000 mg/kg bw: Tonic convulsions with vocalization, decreased activity and prone position, hunched back, piloerection and continuous tremors
- Gross pathology:
- 300 mg/kg bw
At the dose level of 300 mg/kg bw, one animal (out of 6; No. 1425) was found dead on Day 6. Dark red discoloration of the glandular mucosa of the stomach, duodenum, ileum and jejunum, furthermore red discoloration of the non-collapsed lungs could be observed in this animal.
One out of five surviving animals (No.: 1426) showed small, pale, diffuse mottled
discoloration liver in all lobes.
In the other 4 surviving animals, no macroscopic changes were observed.
2000 mg/kg bw
In the 2000 mg/kg bw group, two animals were found dead on Day 0 (No. 1430 and 1432) and one animal (No. 1423) was found dead on Day 1. In the stomach a mixture of clear liquid material and bedding was observed in all animals. Purple discoloration of stomach glandular mucosa was noted in two animals (No.: 1430, 1432) and purple discoloration of duodenum was observed in one animal (No.: 1432).
In addition, red/dark red discoloration of the non-collapsed lungs was noted in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of GDMP was found to be 300 < LD50 ≤ 2000 mg/kg bw in female Han:WIST rats.
According to the GHS criteria, the test item can be ranked as Category 4 for acute
oral exposure. The LD50 cut-off value is 500 mg/kg bw. - Executive summary:
A single dose oral treatment was performed with GDMP according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris) in Han:WIST rats.
Three groups of three female rats each were treated with the test item at a dose level of 300 (Groups 1 and Group 2) or 2000 (Groups 3) mg/kg body weight (bw). The 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 in Polyethylene glycol 400 (PEG 400), at a concentration of 30 or 200 mg/mL and at a dose volume of 10 mL/kg bw.
Initially a group of three animals were treated at the starting dose level of 300 mg/kg bw (Group 1). As no mortality observed after approximately 24 hours, three further animals were treated at the same dose level (Group 2). There were no serious effects noted, therefore a third group of animals was treated at the dose level of 2000 mg/kg bw, which caused the death of 3/3 animals (Group 3). On the 6th day following the treatment, 1/3 animals died from the first dose group (300 mg/kg bw). No further animals were treated according to the study design of OECD 423.
Clinical observations were performed at least once during the first 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter, where possible. Body weight was measured on day 0 (prior to dosing), 7 and 14 (prior to necropsy), where possible. All animals were subjected to a necropsy and a macroscopic examination.
Mortality
At the dose level of 2000 mg/kg bw, 2/3 animals were found dead on Day 0 and 1/3 on Day 1.
At the dose level of 300 mg/kg bw, one animal (out of 6) was found dead on Day 6, five animals survived.Clinical observations
300 mg/kg bw
Treatment at the dose level of 300 mg/kg bw caused clinical symptoms such as slight decreased activity (4/6; No. 1425, 1437, 1443, 1426), hunched back (4/6; No. 1425, 1437, 1443, 1426) and irritability (1/6; No. 1426) on the day of treatment. One animal (No. 1425) showed slight decreased activity with hunched back on Day 1 and moderate decreased activity, intermittent tremors, hunched back on Day 2. From three days
after the treatment moderate decreased activity, hunched back and piloerection could be observed until Day 5. The animal was found dead on Day 6. Five out of six animals were symptom free as of Day 1 until the end of the observation period.2000 mg/kg bw
Tonic convulsions with vocalization were observed twenty minutes after the treatment followed by moderate decreased activity and prone position at thirty minutes after the treatment in two out of three animals (No. 1430, 1432) at the dose level of 2000 mg/kg bw.
The animals were found dead at 1 hour after treatment.
In one animal (No. 1423) moderate decreased activity, hunched back, piloerection and continuous tremors were observed on the day of treatment. The animal was found dead on Day 1.Body weight
There was no evidence of effects on body weight or body weight gain that could be attributed to treatment with the test item in the surviving animals.
Necropsy
300 mg/kg bw
At the dose level of 300 mg/kg bw, one animal (out of 6; No. 1425) was found dead on Day 6. Dark red discoloration of the glandular mucosa of the stomach, duodenum, ileum and jejunum, furthermore red discoloration of the non-collapsed lungs could be observed in this animal.
One out of five surviving animals (No.: 1426) showed small, pale, diffuse mottled discoloration liver in all lobes.
In the other 4 surviving animals, no macroscopic changes were observed.2000 mg/kg bw
In the 2000 mg/kg bw group, two animals were found dead on Day 0 (No. 1430 and 1432) and one animal (No. 1423) was found dead on Day 1. In the stomach a mixture of clear liquid material and bedding was observed in all animals. Purple discoloration of stomach glandular mucosa was noted in two animals (No.: 1430, 1432) and purple discoloration of duodenum was observed in one animal (No.: 1432). In addition, red/dark red discoloration of the non-collapsed lungs was noted in all animals.CONCLUSIONS
Under the conditions of this study, the acute oral LD50 value of the test item was found to be 300 < LD50 ≤ 2000 mg/kg bw in female Han:WIST rats. According to the GHS criteria, GDMP can be ranked as "Category 4" for acute oral exposure. The LD50 cut-off value is 500 mg/kg bw.
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