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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-580-7 | CAS number: 64-19-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, near guideline study, published in peer reviewed literature. No restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- An objective method for the evaluation of eye irritation in vivo
- Author:
- Jacobs GA and Martens MA
- Year:
- 1 989
- Bibliographic source:
- Fd Chem Toxic. Vol 27. No. 4 pp 255-258
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ultrasonic pachometry included, 6 rabbits used
- Principles of method if other than guideline:
- Phase 1 - 3 animals tested and scored clinically; Phase 2 - 3 animals tested, scored and corneal swelling measured using ultrasconic pachometer.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acetic acid
- EC Number:
- 200-580-7
- EC Name:
- Acetic acid
- Cas Number:
- 64-19-7
- Molecular formula:
- C2H4O2
- IUPAC Name:
- acetic acid
- Details on test material:
- - Name of test material (as cited in study report): Acetic acid
- Physical state: liquid
- Analytical purity: 99.5%
- Other: obtained from Merck, Darmstadt, FRG
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Rsk:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Six healthy rabbits used in two phases, each phase separated by about 6 months (3 rabbits per phase)
- No further details reported
ENVIRONMENTAL CONDITIONS
- No details reported.
IN-LIFE DATES: No dates reported
Test system
- Vehicle:
- other: 10% acetic acid in water tested
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 uL
- Concentration (if solution): 10%
- Duration of treatment / exposure:
- 4 h
- Observation period (in vivo):
- 4, 24, 48, 72, 96 and 168 h
- Number of animals or in vitro replicates:
- 3 / phase
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not washed following instillation
SCORING SYSTEM:
- Erythema, chemosis, iritis and corneal opacity were scored according to Draize scores
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - none reported
Ultrasonic pachometry used to assess corneal thickness in Phase 2 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: erythema score, 10% acetic acid
- Irritation parameter:
- other: % corneal swelling
- Basis:
- mean
- Remarks:
- based on three rabbits
- Time point:
- other: 24, 48 & 72 h
- Score:
- 87
- Reversibility:
- not specified
- Remarks on result:
- other: % corneal swelling, 10% acetic acid
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- based on six rabbits
- Time point:
- 24/48/72 h
- Score:
- 1.72
- Reversibility:
- not specified
- Remarks on result:
- other: 10 % acetic acid
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- based on six rabbits
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- not specified
- Remarks on result:
- other: 10% acetic acid
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not reported
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not reported
- Irritant / corrosive response data:
- Instillation of 10% acetic acid resulted in a mean erythema score of 2.67, which is considered to justify the classification "irritant" according to EEC classification, and a mean % corneal swelling of 87%.
There was shown to be a good correlation between corneal opacity and corneal swelling in this study and from this it was deduced that 80% mean corneal swelling corresponds to a corneal opacity value of 2, the EEC threshold for classification as an irritant.
was irritant to the rabbit eye - Other effects:
- None reported
Any other information on results incl. tables
Table 1 - Eye irritation scores for 10% acetic acid
Mean erythema score |
Mean chemosis score |
Mean corneal opacity score |
Mean % corneal swelling |
2.67 * |
1.67 |
1.72 |
87 * |
Means are for 6 rabbits, except for mean % corneal swelling which is for 3 rabbits.
* these values justify the term irritant
The mean erythema, chemosis and corneal opacity scores were calculated for all six rabbits and the scores at the three observation times, 24, 48 and 72 h, were pooled. In this study mean erythema was calculated by reading the erythema of the upper eyelid, the lower eyelid and the nictitating membrane. The mean of thee readings was considered to be the erythema of the palpebral conjunctiva of a rabbit at a given time.
Corneal swelling was expressed as a percentage and calculated according to the formula:
%CS= [(corneal thickness at time t / corneal thickness at time 0) - 1] x 100.
The mean % swelling is calculated over 3 rabbits for each observation time.
Applicant's summary and conclusion
- Conclusions:
- 10% acetic acid was shown to be irritating to the rabbit eye using the mean erythema score and % corneal swelling as measured using ultrasonic pachometry.
- Executive summary:
To eliminate the difficulties of subjective judgement in assessing eye irritants, the relationship between corneal swelling, measured objectively using ultrasonic pachometry, and the reading of other symptoms was investigated in this study, using 34 substances. Erythema, oedema and corneal opacity were evaluated according to EEC directive 83/467/EEC. Good correlations were found between the mean percentage corneal swelling after 24, 48 and 72 h and mean corneal opacity (r=0.94) and erythema scores (r=0.93) after the same observation times.
10% acetic acid was shown to be irritating to the rabbit eye using the mean erythema score and % corneal swelling as measured using ultrasonic pachometry.
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.