Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 919-274-6 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 31 October 2007 to 15 November 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- - animal room humidity was outside the preferred range of 30-70 %. Erythema grade 1 was also documented with a score of maximized grade 4, however per protocol, due to an eschar score of >1, a maximized grade 4 is the only erythema grade needed.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- - animal room humidity was outside the preferred range of 30-70 %. Erythema grade 1 was also documented with a score of maximized grade 4, however per protocol, due to an eschar score of >1, a maximized grade 4 is the only erythema grade needed.
- Principles of method if other than guideline:
- The deviations detailed above are not considered to have an impact on the validity of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sponsor's identification: AS305BD
Description: dark brown, viscous liquid
Lot number: TS07002
Analytical purity: 100%
Storage conditions: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 344-296 g prior to dosing (males); 227-252 g prior to dosing (females)
- Fasting period before study:
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rodent Chow #5002 (PMI Nutrition International) ad libitum
- Water (e.g. ad libitum): municipal tap water ad libitum
- Acclimation period: a minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 16059
- Air changes (per hr): 10-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark
IN-LIFE DATES: From: 1st November 2007 To: 15th November 2007
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: approximately 10%
- Type of wrap if used: test material was held in contact with the skin with an appropriately sized 4-ply porous gauze dressing backed with plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using a gauze mositened with mineral oil, USP, followed by dry gauze, followed by gauze moistened with deionized water, followed by dry gauze
- Time after start of exposure: approximately 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dose volume = 2.08 mL/kg - Duration of exposure:
- Approximately 24 hours exposure; 14 days for observations
- Doses:
- Single dermal administration of the test article at a dose level of 2000 mg/kg body weight
- No. of animals per sex per dose:
- Five male and five female rats
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: test animals examined for erythema and edema after patch removal on day 1 and daily thereafter. Test animals examined for clinical abnormalities a mimnimum of two days on study day 0 and daily thereafter. Individual bodyweights obtained prior to dosing on day 0, day 7 and day 14.
- Necropsy of survivors performed: yes - Statistics:
- Based on the results of each dose level, the LD50 was estimated as follows:
- <50% mortality - LD50 was estimated as greater than the administered dose
- =50% mortality - LD50 was estimated as equal to the administered dose
- >50% mortality - LD50 was estimated as less than the administered dose
Bodyweight means and standard deviations were calculated separately for males and females.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- Transient incidences of dark material around the facial area, hair loss, labored breathing, aggressiveness, urine stain, and few feces
- Body weight:
- Two males and one female had a slight body weight loss on day 7, but all animals gained body weight by the end of the test period
- Gross pathology:
- Mandibular lymph node foci and a raised area of the skull both of which were noted in one female animal. Scabs and flaking of the treated skin were also noted at necropsy. External findings of hair loss (of the forelimbs) were noted in one female at necroscopy.
- Other findings:
- Dermal irritation consisted of erythema maximized grade 4 (with notable dermal lesion of blanching), which was noted in all animals during the study and diminished to well-defined erythema in 4 males or to slight erythema in 1 male and 5 females. Slight edema was noted in 3 males and 3 females and very slight edema was noted in 5 males and 5 females during the study. Desquamation (all animals), superficial lightening (2 males and 3 females), blanching (all animals), and eschar (3 males and 5 females) were also noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this test, the acute dermal LD50 of AS305BD was estimated to be greater than 2000 mg/kg in the rat.
- Executive summary:
An acute dermal toxicity study was performed on male and female rats at a single dose of 2000 mg/kg bodyweight in line with OCED Guideline 402.
No mortality occurred during the study. A number of clinical observations were observed during the study. Dermal irritation consisted of erythema maximized grade 4 (with notable dermal lesion of blanching), which was noted in all animals during the study and diminished to well-defined erythema in 4 males or to slight erythema in 1 male and 5 females. Slight edema was noted in 3 males and 3 females and very slight edema was noted in 5 males and 5 females during the study. Desquamation (all animals), superficial lightening (2 males and 3 females), blanching (all animals), and eschar (3 males and 5 females) were also noted during the study. Two males and one female had slight body weight loss at day 7 but all animals gained body weight by the end of the study.
Under the conditions of the study, the acute detmal LD50 of AS305BD was estimated to be > 2000 mg/kg in the rat.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.