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EC number: 261-222-3 | CAS number: 58353-68-7
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not performed under GLP,however the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics”, by the Staff of the Division of Pharmacology, FDA (1959)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts
- IUPAC Name:
- Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Steinamat B 1003.
- Physical state: White, opaque, viscous substance
- Analytical purity: 35%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided
- Other: pH 10.5
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zucht Winkelmann, Paderborn)
- Age at study initiation: Not provided
- Weight at study initiation: 110- 170g
- Fasting period before study: 16 hours
- Housing: Individual cages
- Diet (e.g. ad libitum): Ssniff/Intermast ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not provided
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 45-55%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: Not provided
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 35% watery solution
- Doses:
- 6.30 mL/kg (2205 mg act.ingr./kg bw)
7.94 mL/kg (2779 mg act.ingr./kg bw)
10.0 mL/kg (3500 mg act.ingr./kg bw)
12.60 mL/kg (4410 mg act.ingr./kg bw)
15.90 mL/kg (5565 mg act.ingr./kg bw) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
-Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- After Litchfiel & Wilcoxon, in conjunction with the Gaussian integral
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10.4 mL/kg bw
- Based on:
- test mat.
- Remarks:
- 35% watery solution
- Remarks on result:
- other: at 48h and 7 days
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3.64 other: g/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: at 48 hours and 7 days
- Mortality:
- Mortalities occurred within 48h after application. (See Table 1)
- Clinical signs:
- other: The test substance evoked at the tested doses, an increasing degree of activity reduction, incoordination, diarrhea and piloerection. In the highest dose, animals also showed abnormalities in position and posture and decreased reflexive excitability. The
- Gross pathology:
- At necropsy, in the acute mortality group, strong reddened gastric and intestinal mucosa was found. At necropsy, in the group of animals killed at the end of testing, no pathological changes were found in skull, chest and abdominal cavity.
Any other information on results incl. tables
Table 1. Mortality
Group |
Dose |
24 hours |
48 hours |
14 days |
I |
6.30 mL/kg |
0/10 |
0/10 |
0/10 |
II |
7.94 mL/kg |
2/10 |
2/10 |
2/10 |
III |
10.00 mL/kg |
2/10 |
4/10 |
4/10 |
IV |
12.60 mL/kg |
8/10 |
8/10 |
8/10 |
V |
15.90 mL/kg |
10/10 |
10/10 |
10/10 |
Table 2. Mean Body weight
Group |
Initial body weight |
Body weight after 14 days |
I |
137.5 g |
173.0 g |
II |
142.0 g |
168.8 g |
III |
143.5 g |
180.0 g |
IV |
132.0 g |
170.0 g |
V |
161.5 g |
-- |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance (35% act.ingr.) was undiluted subjected to an acute toxicity test after single oral application in rats. Under the described experimental conditions the following was found:
1. The 24h-LD50 could be determined as 10.6 mL/kg. The 48 h- LD50 was calculated as 10.4 mL/kg (corresponding to 3640 mg act.ingr./kg bw) and corresponded with the 7d- LD50 because no late mortalities occurred.
2. The fluctuation of the acute toxicity was well delineated due to the slope factor S. - Executive summary:
The test item (35% aqueous solution) was administered to 5 groups of SPF-Wistar rats (5 males and 5 females/group) at doses of 6.3, 7.94, 10.00, 12.60 and 15.90 mL/kg bw. Mortalities occurred within 48h after application. The test substance evoked at the tested doses, an increasing degree of activity reduction, incoordination, diarrhea and piloerection. In the highest dose, animals also showed abnormalities in position and posture and decreased reflexive excitability. The symptoms occurred within 1 hour after application and held on for 24 hours . Thereafter, all surviving animals, showed normal behavior during the entire observation period. At the end of the 14 days observation period all surviving animals showed normal body weight gain rates. At necropsy , in the acute mortality group, strong reddened gastric and intestinal mucosa was found. At necropsy, in the group of animals killed at the end of testing, no pathological changes were found in skull, chest and abdominal cavity. The acute oral LD50was 3640 mg act. ingr./kg bw.
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