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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- The intial weight of animal (no. 075) was above the preferrred range specified in the General Study Plan (2.0 - 3.0kg). This deviation has no impact on the integrity of the test.
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elvage Scientifique des Dombes 01400 Chatillon sur Chalaronne, France
- Age at study initiation: Approximately 8-12 weeks
- Weight at study initiation: 2810 - 3120 g
- Housing: Individual
- Diet (e.g. ad libitum): NAFAG No. 814 (NAFAG, Gossau/SG, Switzerland), available ad libitum.
- Water (e.g. ad libitum): Available ad libitum from automatic dispensers; source is municipal water supply.
- Acclimation period: 5 days before treatment
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
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours and 7 days after treatment.
- Observation period (in vivo):
- 7 days (sufficient to determine reversibilityof efects).
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes - washed with distilled water for 1 minute
- Time after start of exposure: 24 hours
SCORING SYSTEM: OECD/EEC - Grading of Ocular Lesions
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: for full results see table below
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: for full results see table below
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: for full results see table below
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 days
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: for full results see table below
- Irritant / corrosive response data:
- Scattered or diffused areas of corneal opacity (score of 1) in two animals (no. 106 and 075) and scattered areas of corneal opacity up to slightly opaque cornea (scores of 1-2) in one animal (no. 044) were scene from 1 hour through 3 days after treatment. Moderate hyperaemia of the iris (score of 1) was observed in one animal (no. 075) at the 48 hour reading only, in one animal (no. 106) from 24 hours through to 48 hours after treatment, and in one animal (no. 044) from 1 hour through to 72 hours after treatment. Diffuse, crimson coloured conjunctival redness (score of 2) and above normal swelling of the eyelids and nictitating membranes up to obvious swelling with partial eversion of lids (score of 1-2) were observed in all animals from 1 hour through 72 hours after treatment. All eye reactions were reversed by day 7. The results of the eye examinations for individual animals are presented I Table 1. Mean irritation scores for eye reaction according to OECD/EEC guidelines (24-72 hours) are presented I Table 2.
- Other effects:
- There was no mortality in the test.
There were no remarkable clinical observations.
Body weights were not affected by treatment. Body weights are presented in Table 3.
Any other information on results incl. tables
Table 1: Individual Eye Irritation Scores
SEX / ANIMAL NO. |
F / 106 |
F/ 075 |
F / 044 |
|||
|
CORNEA |
|||||
|
CE |
TE |
CE |
TE |
CE |
TE |
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS AFTER 7 DAYS |
0 0 0 0 0 |
1 1 1 1 0 |
0 0 0 0 0 |
1 1 1 1 0 |
0 0 0 0 0 |
1 2 1 1 0 |
|
IRIS |
|||||
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS AFTER 7 DAYS |
0 0 0 0 0 |
0 1 1 0 0 |
0 0 0 0 0 |
0 0 1 0 0 |
0 0 0 0 0 |
1 1 1 1 0 |
|
|
|||||
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS AFTER 7 DAYS |
0 0 0 0 0 |
2 2 2 2 0 |
0 0 0 0 0 |
2 2 2 2 0 |
0 0 0 0 0 |
2 2 2 2 0 |
|
|
|||||
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS AFTER 7 DAYS |
0 0 0 0 0 |
2 1 1 1 0 |
0 0 0 0 0 |
2 2 2 1 0 |
0 0 0 0 0 |
2 2 1 1 0 |
CE: CONTROL EYE TE: TEST EYE |
Table 2: Summary Eye Irritation Indices (OECD/EEC)
Mean Scores for 24, 48 and 72 hour readings
SEX / ANIMAL NO. |
F / 106 |
F/ 075 |
F / 044 |
MEAN |
CORNEA |
1 |
1 |
1.33 |
1.11 |
IRIS |
0.67 |
0.33 |
1 |
0.67 |
CONJUNCTIVAL REDNESS |
2 |
2 |
2 |
2 |
CONJUCTIVAL CHEMOSIS |
1 |
1.67 |
1.33 |
1.33 |
Table 3: Body Weights (g)
SEX / ANIMAL NO. |
F / 106 |
F/ 075 |
F / 044 |
AT TEST START AFTER 3 DAYS AT TEST END (7 DAYS) |
3000 3020 3220 |
3120 3140 3250 |
2810 2840 2900 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the test results, CA 2215 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.
- Executive summary:
An eye irritation/corrosion test was conducted with test article CA 2215 A (Intermediate CGA 276854) (batch P.608005). The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours and 7 days after treatment.
The test article induced reactions of the cornea in all animals beginning 1hour after treatment and cleared within 7 days. Slight reactions of the iris were seen in all animals, which cleared within 7 days after treatment at the latest. Redness and swelling of the conjunctiva was observed in all animals between 1hour and 3 days after treatment. All eye reactions were clear by day 7 after treatment. There was no mortality, and no remarkable clinical observations. Body weights were not affected by treatment.
According to the test results, CA 2215 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.
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