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EC number: 250-157-6 | CAS number: 30374-01-7
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Sep 2008 - 26 Nov 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: First addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 404, "Acute Dermal Irritation/Corrosion" adopted 24th April, 2002.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Isooctyl 3-mercaptopropionate
- EC Number:
- 250-157-6
- EC Name:
- Isooctyl 3-mercaptopropionate
- Cas Number:
- 30374-01-7
- Molecular formula:
- C11H22O2S
- IUPAC Name:
- 2-methylheptyl 3-sulfanylpropanoate
- Details on test material:
- - Name of test material (as cited in study report): Isooctyl mercaptopropionate
- Analytical purity: 99.9 % area (GC)
- Purity test date: 2008-08-26
- Lot/batch No.: 24317
- Expiration date of the lot/batch: 2009-08-11
- Physical state: liquid at RT
- Storage: at room temperature
- Other: colorless
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 190 - 200 g
- Housing: Semi-barrier condition in an air conditioned room; animals were kept in IVC cages, type III H, polysulphone cages on Altromin saw fiber bedding
- Diet (ad libitum): free access to Altromin 1324 maintenance diet for rats and mice
- Water (ad libitum): free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, micro biologically controlled at frequent intervals)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): artificial light, sequences being 12 hours light, 12 hours dark
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no less than 10 %
- Type of wrap if used: The test article was held in contact with the skin by a dressing which consisted of a gauze-dressing and non-irritating tape, and was fixed with an additional dressing in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure, residual test item was removed by using aqua ad injectionem (B. Braun Melsungen; Lot 7494A191).
- Time after start of exposure: The test article was held in contact with the skin throughout a 24 hour period.
TEST MATERIAL
- Amount(s) applied (weight with unit): 2000 mg/kg bw
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- A total of five animals was made up of one animal from the sighting study dosed at the selected dose level together with additional four animals.
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made immediately after the dosing, at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours, and daily thereafter. Primary skin irritation was assessed 1, 2 and 3 days after removal of the test substance.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Primary skin irritation was assessed using the scoring system laid down in OECD 404.
Results and discussion
- Preliminary study:
- A sighting study was performed to allow the selection of the appropriate starting dose for the main study. The test article was applied to one female at a dose of 2000 mg/kg body weight (oral LD50 rat >2000 mg/kg bw).
As the animal survived, the main test was performed with the same dose, with four additional animals.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occured.
- Clinical signs:
- other: In the main study 1 out of 4 animals showed a bloody nose on day 9 after the application of the test item. This finding is considered to be incidental and not treatment related. No other clinical signs of toxicity were observed throughout the observation
- Body weight:
- other body weight observations
- Remarks:
- For animal no. 3, a minimal weight loss of 1 g during the first week was recorded. The body weight development of further animals was within the expected range.
- Gross pathology:
- At necropsy of the main study, 1 out of 4 animals showed a clearly visible prominence and light-colored deposits on the spleen as well as dark-colored spots on the right heart ventricle. In the absence of clinical signs, this isolated finding does not appear to be of toxicological significance or a resultof treatment. Except for acute injection of blood vessels in the abdominal region, which was caused by the euthanasia injection, no specific gross pathological changes were found in any of the other animals.
- Other findings:
- No signs of skin irritaion were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 was determined to be > 2000 mg/kg bw. Therefore, the test item Isooctyl mercaptopropionate is unclassified according to the criteria of Annex VI to Commission Directive 2001/59/EC. Judging from the absence of local skin effects after 24 hours of exposure to 2000 mg/kg bw, it is concluded that the test article is not a primary skin irritant.
- Executive summary:
This study was conducted to assess the acute dermal toxicity of the test item iOMP after a single dermal administration to 5 female Wistar rats in accordance eith OECD TG 434.
The test item was applied as a single dose uniformly over an area which was approx. 10% of the total body surface.
The test item was held in contact with the skin by a dressing which consisted of a gauze-dressing and non-irritating tape, and was fixed with an additional dressing in a suitable manner. The starting dose was 2000 mg/kg body weight.The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure, residual test item was removed by using aqua ad injectionem.
The dermal LD50 was determined to be > 2000 mg/kg bw.
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