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EC number: 700-908-3 | CAS number: 19444-21-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Full study report with GLP compliance statement
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- prop-2-en-1-yl 2-hydroxy-2-methylpropanoate
- EC Number:
- 700-908-3
- Cas Number:
- 19444-21-4
- Molecular formula:
- C7H12O3
- IUPAC Name:
- prop-2-en-1-yl 2-hydroxy-2-methylpropanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Biological Research Laboratories Ltd, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: Young aduls (approximately 7-11 weeks)
- Weight at study initiation: 163-187 g
- Fasting period before study: Fasted overnight prior to dosing
- Housing: 5 same -sex animals per cage
- Diet : available ad libitum
- Water: availabale ad libitum from bottles.
- Acclimation period: 5days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50% ± 20%
- Air changes (per hr): 13-14/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% in 0.1% aqueous polysorbate 80
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/kg:404 mg test article with vehicle ad 20ml. 500mg/kg: 1251mg test article with vehicle ad 25 ml.
Volume applied by gavage: 10ml/kg
DOSE LEVELS: 200mg/kg (Females), 500mg/kg (both sexes)
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: EU classification criteria and pre-test results. - Doses:
- 200 and 500mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females at 500mg/kg
5 females at 200mg/kg - Control animals:
- no
- Details on study design:
- Period of observation: 14 days.
Clinical Observations: Checked and recorded individually at 1,3 and 5 hours after dosing, then daily for the duration of the observation period.
Mortality: Checked twice daily, morning and afternoon.
Body weight: Measured and recorded imediately before dose administration, then on days 7 and 14.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Four females (80%) (no. 101, 102, 103 and 105) in the 500mg/kg group were found dead 1 day after treatment. Therfore, the following acute oral LD50 values were determined for CA 2215 A (Intermediate for CGA 276854). Refer to Effect levels above.
Table 1. - Clinical signs:
- other: On the treatment day through day 5, slight up to moderate piloerection was seen in four males (no. 1 2, 3, and 5) and slight up to severe piloerection in one male (no. 4). Slight up to severe piloerection was seen in all females in the 500mg/kg group on
- Gross pathology:
- Necropsy
Necropsy examinations revealed fibrinous adhesions in the abdominal cavity in all males and one female (no. 104) in the 500 mg/kg group. Organs involved were stomach, spleen and liver. Necropsy observations
Any other information on results incl. tables
Table 1 - Mortality
Males |
No. of deaths |
% of Deaths |
Group 1 (500mg/kg) |
0/5 |
0 |
Females |
|
|
Group 1 (500mg/kg) |
4/5 |
80 |
Group 2 (200mg/kg) |
0/5 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Acute Tox 3 Criteria used for interpretation of results: EU
- Conclusions:
- Study results used to clasify under Regulation (EC) No. 1272/2008 Sectio n3.1 Acute Toxicity.
Classification determined Acute Tox. Cat. 3 - H301 - Executive summary:
Groups of 5 male and 5 female rats were administered a single dose of CA 2215 A
(Intermediate of CGA 276854) (batch P.608005) by gavage at dose levels of 200 mgkg
(females) and 500 mgkg (both sexes), followed by a 14-day post-treatment observation
period.
Four females in the 500 mglkg group were found dead 1 day after treatment.
Piloerection of various intensity was seen in all males and all females on the treatment
day, and persisted up to day 5 in the males and day 7 in the surviving 500 mgkg
female. Hunched posture was seen in all animals on the treatment day, and in all males
and in the surviving female in the 500 mg/kg group on day 1 and 5 after treatment. In
the 500 mgkg groups, slight up to moderate hypoactivity was seen in two males and
slight up to severe hypoactivity was seen in three males and all females. All males
appeared normal by day 6 after treatment, the surviving female in the 500 mgkg group
appeared normal by day 8 after treatment, and all females in the 200 mgkg group
appeared normal by day 1 after treatment,
A loss of body weight was recorded in one male animal during the first week after
treatment.
Necropsy examinations revealed fibrinous adhesions in the abdominal cavity in all
males and in one female in the 500 mg/kg group. Organs involved were stomach, spleen
and liver.
The following acute oral LDso values were determined for CA 2215 A (Intermediate of
CGA 276854):
LDso in male rats: Greater than 500 mgkg body weight
LDsoin female rats: Greater than 200, lower than 500 mgkg body weight
LDso in rats of both sexes: Greater than 200, lower than 500 mgkg body weight
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