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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 916-328-0 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th February 2018 - 3rd May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate
- EC Number:
- 916-328-0
- Molecular formula:
- C10H18O3
- IUPAC Name:
- Reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: O’Laughlin (Nantong) Fine Chemicals Co., Ltd.; NTA375
- Expiration date of the lot/batch: Sep 25, 2020
- Purity: CAS No. 67634-00-8: 79.45 %; CAS No.: 67634-01-9 20.28 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Lysolajské údolí 15/53, 165 00 Prague 6, Czech Republic, RČH CZ 11760500
- Females (if applicable) nulliparous and non-pregnant: Yes
- Weight at study initiation: 211-236 g
- Housing: Animal room with monitoring conditions; shavings of soft wood
- Diet: Pelleted standard diet for experimental animals ad libitum
- Water: Drinking tap water ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 – 70 %
- Photoperiod (hrs dark / hrs light): 12-hour light/12 hour dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: About 6 x 6 cm on the back of animals (shaved)
- % coverage: Approx. 10 % of the body surface
- Type of wrap if used: Gauze and held in contact by plaster (strapping)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No - Duration of exposure:
- 24 hrs
- Doses:
- Range finding study: 1000 mg/kg bw
Main study: 200, 1000 mg/kg bw/day - No. of animals per sex per dose:
- Range finding study: 1 female
Main study: 2 females per dose - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: After application the animals were observed individually:
-the first day: three times (30 minutes, 3 and 6 hours after application)
- the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days
- Frequency of observations and weighing: The animals were weighed at the start of the study (before application), at 8th day and at the end of experiment (15th day).
- Necropsy of survivors performed: All test animals surviving to the end of study were sacrificed on the 15th day by diethyl ether narcosis and gross necropsy was carried out. Nutritional state, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated
- Other examinations performed: Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system
Results and discussion
- Preliminary study:
- The test item at the dose level 1000 mg/kg bw caused the death of the animal. Clinical signs of intoxication noted as apathy, decreased reaction to stimuli and red discharge from nostrils were observed 6 hours after administration of the test item. The following morning, the animal was found dead. Red-stained fur around the urethra outflow was recorded. Red-stained content of the small intestine and congested small intestine were observed. Based on these results, the main study with two females was started with the dose of 200 mg/kg bw.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - <= 2 000 mg/kg bw
- Mortality:
- No death of animals was recorded at the dose level 200 mg/kg bw. One of the two females at the dose level 1000 mg/kg bw died during the main study.
- Clinical signs:
- other: Clinical signs of toxicity noted as apathy, decreased reaction to stimuli, bradypnoea, piloerection, red discharge form nostrils, dark red-stained urine were observed in females at the dose level 1000 mg/kg bw. No clinical signs of toxicity were recorded
- Gross pathology:
- During the pathological examination, changes as dilatation of the small intestine, congestion of the intestine and dark red-stained urine were diagnosed in one female dosed by 1000 mg/kg bw. No macroscopic findings were recorded in females at the dose level 200 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an acute dermal toxicity study in rats, the LD50 for allyl amyl glycolate was >1000 mg/kg bw - ≤2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (18 -163) 2 female Wistar rats were dermally exposed (semi-occlusive) to allyl amyl glycolate at doses of 200 and 1000 mg/kg bw for 24 hours. Animals were then observed for 14 days.
Dermal LD50 (Females) = >1000 mg/kg bw - ≤2000 mg/kg bw.
No death of animals was recorded at the dose level 200 mg/kg bw. One of the two females at the dose level 1000 mg/kg bw died. The body weight gain was adequate to species, sex and age of animals except very little body weight gain in one animal at 200 mg/kg bw. No clinical signs of toxicity were recorded in females at the dose level 200 mg/kg bw. Clinical signs of toxicity noted as apathy, decreased reaction to stimuli, bradypnoea, piloerection, red discharge form nostrils, dark red-stained urine were observed in females at the dose level 1000 mg/kg bw. No macroscopic findings were recorded in females at the dose level 200 mg/kg bw. During the pathological examination, changes as dilatation of the small intestine, congestion of the intestine and dark red-stained urine were diagnosed in one female dosed by 1000 mg/kg bw.
This acute dermal study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study (OECD 402) 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.