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EC number: 201-604-9 | CAS number: 85-42-7
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
- Stability
- Biodegradation
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- 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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA
- Principles of method if other than guideline:
- Test substance administered to the eye of 6 rabbits. Treated eyes of 3 rabbits washed after 30 seconds. Reaction assessed after 1, 24, 48 and 72 hours, 6, 10 and 14 days
- GLP compliance:
- no
Test material
- Reference substance name:
- Cyclohexane-1,2-dicarboxylic anhydride
- EC Number:
- 201-604-9
- EC Name:
- Cyclohexane-1,2-dicarboxylic anhydride
- Cas Number:
- 85-42-7
- Molecular formula:
- C8H10O3
- IUPAC Name:
- octahydro-2-benzofuran-1,3-dione
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):TK 10 946
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: In-house breeding
- Age at study initiation: 12 - 15 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: Individually caged
- Diet (e.g. ad libitum): Styles-Oxoid commercial rabbit diet, ad libitum
- Water (e.g. ad libitum): Sterile filtered water, ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 50 - 70%
- Photoperiod (hrs dark / hrs light): 10 hours light / 14 hours dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single administration. The eyes of 3 animals washed 30 seconds after administration
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 6, 10 and 14 days
- Number of animals or in vitro replicates:
- 6, 3 unwashed and 3 washed
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 3 rabbits, 200 mL warm water
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: fluorescein staining to aid visualisation of corneal lesions
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
Any other information on results incl. tables
Unwashed
|
Animal Number: 11 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
2 |
3 |
3 |
2 |
|
|
Conjunctivae: |
Chemosis: |
2 |
2 |
2 |
2 |
4 |
|
|
|
Redness: |
2 |
3 |
3 |
3 |
2 |
|
|
Iris: |
Inflammation: |
0 |
1 |
1 |
1 |
1 |
|
|
Cornea: |
Opacity: |
2 |
1 |
1 |
1 |
2 |
|
|
|
Area: |
4 |
4 |
4 |
4 |
4 |
|
|
Unwashed
|
Animal Number: 13 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
3 |
3 |
3 |
3 |
2 |
|
|
Conjunctivae: |
Chemosis: |
2 |
3 |
3 |
3 |
3 |
|
|
|
Redness: |
2 |
3 |
3 |
3 |
3 |
|
|
Iris: |
Inflammation: |
0 |
1 |
1 |
1 |
1 |
|
|
Cornea: |
Opacity: |
2 |
1 |
1 |
1 |
2 |
|
|
|
Area: |
4 |
4 |
4 |
4 |
3 |
|
|
Unwashed
|
Animal Number: 12 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
3 |
3 |
3 |
3 |
|
|
Conjunctivae: |
Chemosis: |
3 |
3 |
2 |
2 |
3 |
|
|
|
Redness: |
2 |
3 |
3 |
3 |
3 |
|
|
Iris: |
Inflammation: |
0 |
1 |
1 |
1 |
1 |
|
|
Cornea: |
Opacity: |
2 |
1 |
1 |
2 |
2 |
|
|
|
Area: |
4 |
4 |
4 |
3 |
3 |
|
|
Washed
|
Animal Number: 15 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
Conjunctivae: |
Chemosis: |
2 |
3 |
2 |
2 |
1 |
0 |
0 |
|
Redness: |
2 |
3 |
3 |
3 |
3 |
3 |
1 |
Iris: |
Inflammation: |
1 |
1 |
1 |
0 |
0 |
0 |
0
|
Cornea: |
Opacity: |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Area: |
4 |
4 |
4 |
4 |
4 |
2 |
1
|
Washed
|
Animal Number: 14 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
3 |
3 |
2 |
1 |
0 |
1 |
0 |
Conjunctivae: |
Chemosis: |
3 |
3 |
2 |
2 |
1 |
1 |
1 |
|
Redness: |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
Iris: |
Inflammation: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: |
Opacity: |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Area: |
4 |
4 |
4 |
3 |
3 |
1 |
1 |
Washed
|
Animal Number: 16 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
3 |
2 |
1 |
0 |
0 |
0 |
Conjunctivae: |
Chemosis: |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
|
Redness: |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
Iris: |
Inflammation: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: |
Opacity: |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Area: |
3 |
4 |
2 |
2 |
2 |
1 |
1 |
Unwashed
|
||||
Animal Number |
Conjunctival Redness
|
Conjunctival Chemosis |
Iris Inflammation |
Corneal Opacity
|
11 13 12 |
3.0 3.0 3.0 |
2.0 3.0 2.3 |
1.0 1.0 1.0 |
1.0 1.0 1.3
|
The mean score recorded for each animal is the average of the individual scores observed at the 24, 48 and 72 hour examinations. |
Washed
|
||||
Animal Number |
Conjunctival Redness
|
Conjunctival Chemosis |
Iris Inflammation |
Corneal Opacity
|
15 14 16 |
3.0 3.0 3.0 |
2.3 2.3 1.7 |
0.7 0.0 0.0 |
1.0 1.0 1.0
|
The mean score recorded for each animal is the average of the individual scores observed at the 24, 48 and 72 hour examinations. |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Primary eye irritation has been investigated in the rabbit. Hexahydrophthalic anhydride causes serious eye damage.
- Executive summary:
Acute eye irritation has been investigated in the rabbit following administration of a single dose and following FHSA test methods, which are similar to current OECD test methods. Hexahydrophthalic anhydride causes serious eye damage.
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.
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