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EC number: 204-179-8 | CAS number: 117-21-5
- 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
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-chlorophthalic anhydride
- EC Number:
- 204-179-8
- EC Name:
- 3-chlorophthalic anhydride
- Cas Number:
- 117-21-5
- Molecular formula:
- C8H3ClO3
- IUPAC Name:
- 4-chloro-1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male and female New Zealand White rabbits, at least 10 weeks of age, weighing 2.01 to 2.46 kg were obtained from Millbrook Breeding Labs. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages with hardwood chip bedding. They were provided food and tap water ad libitum. Room temperature was 68 ± 5°F and the relative humidity ranged between 30-70%. Room lights were on a 12-hour light/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Approximately 24 hours prior to dosing, the eyes of the animals selected for the test were examined to insure that the eyes were free of abnormality, damage and disease. The animals were dosed in the left eye at a volume of 0.1 mL (equivalent to 100 mg).
- Duration of treatment / exposure:
- The test substance was instilled into the left eye by gently pulling the lower lid away from the eye to form a cup into which the test substance was placed. The upper and lower lids were gently held together for approximately one second to prevent the loss of the test substance. The eyes were rinsed within two hours of instillation as the test substance was not removed from the eye by physiological mechanisms.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours according to the definitions provided below. Animals were observed daily for clinical signs of toxicity. Animals were weighed at study start and on Days 6 and 17, when applicable.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2
- Remarks:
- mean value; not determinable in animal 3 due to discharge
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: animal #2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 3.1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Moderate corneal involvement was noted at the one hour mark in all three test eyes. At Day 6, this developed into pannus in two test eyes. The findings resolved in one animal by Day 8. Mild iritis was observed in two animals at 24 hours. The iris could not be observed in the third animal at 24 and 48 hours due to profound swelling, but iritis was noted at 72 hours, and continued in this animal through Day 6. Iris involvement persisted in the remaining two animals through the determination of irreversibility. Moderate conjunctival involvement was noted in all three test eyes by the one hour observation point. Involvement persisted through the conclusion of the study. Irreversible change was observed in one animal in the form of conjunctival ulceration/scarring.
- Other effects:
- All animals gained weight and no systemic signs of toxicity were observed during the course of the study.
Any other information on results incl. tables
· Rabbit No. |
Effects at 1 hour |
Effects at 24 hours |
FE |
Effects at 48 hours |
FE |
|
|||||||||||||||||||||||
Cornea |
Iris |
Conj |
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
|
||||||||||||||||
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
|
||||||||||||||
44207 |
1 |
3 |
0 |
2* |
3 |
2 |
3 |
1 |
3** |
3 |
2 |
4 |
3 |
3 |
1 |
3^ |
3 |
2 |
3 |
|
|||||||||
44208 |
2 |
3 |
0 |
2* |
3 |
2 |
3 |
1 |
3* |
3 |
2 |
2 |
2 |
3 |
0 |
3^ |
3 |
2 |
2 |
|
|||||||||
44209 |
2 |
4 |
0 |
2* |
3 |
2 |
4@ |
** |
3* |
4 |
2 |
4@ |
2 |
4@ |
** |
3* |
4 |
2 |
4@ |
|
|||||||||
|
|||||||||||||||||||||||||||||
Rabbit No. |
Effects at 72 hours |
FE |
Effects at Day 4 |
FE |
Effects at Day 5 |
FE |
|||||||||||||||||||||||
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
|
||||||||||||||
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
|
||||||||||||||
44207 |
3 |
2 |
1 |
3^ |
3 |
3 |
2 |
3 |
3 |
1 |
3^ |
3 |
3 |
3 |
3 |
2 |
1 |
2^ |
3 |
3 |
2 |
|
|||||||
44208 |
1 |
3 |
0 |
3* |
2 |
2 |
2 |
1 |
2 |
1 |
3* |
2 |
2 |
1 |
1 |
1 |
1 |
3* |
2 |
1 |
1 |
|
|||||||
44209 |
3 |
4@ |
1 |
3* |
3 |
3 |
4@ |
3 |
4@ |
** |
3^ |
4 |
3 |
4@ |
3 |
4@ |
1 |
3^ |
4 |
3 |
4@ |
|
|||||||
|
|||||||||||||||||||||||||||||
Rabbit No. |
Effects at Day 6 |
FE |
Effects at Day 7 |
FE |
Effects at Day 8 |
FE |
|
||||||||||||||||||||||
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
|
||||||||||||||
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
|
||||||||||||||
44207 |
3~ |
2 |
1 |
2 |
3 |
3 |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
|||||||
44208 |
1 |
1 |
0 |
2* |
2 |
1 |
1 |
1 |
1 |
0 |
2* |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
|
|||||||
44209 |
3~ |
4@ |
1 |
3 |
4 |
3 |
4@ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
|||||||
|
|||||||||||||||||||||||||||||
Rabbit No. |
Effects at Day 9 |
FE |
Effects at Day 10 |
FE |
Effects at Day 11 |
FE |
|
||||||||||||||||||||||
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
|
||||||||||||||
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
|
||||||||||||||
44208 |
0 |
0 |
0 |
2** |
2 |
0 |
0 |
0 |
0 |
0 |
1** |
2 |
0 |
0 |
0 |
0 |
0 |
2** |
2 |
0 |
0 |
|
|||||||
|
|||||||||||||||||||||||||||||
Rabbit No. |
Effects at Day 12 |
FE |
Effects at Day 13 |
FE |
Effects at Day 14 |
FE |
|
||||||||||||||||||||||
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
|
||||||||||||||
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
|
||||||||||||||
44208 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
1* |
2 |
0 |
0 |
|
|||||||
|
|||||||||||||||||||||||||||||
Rabbit No. |
Effects at Day 15 |
FE |
Effects at Day 16 |
FE |
Effects at Day 17 |
FE |
|
||||||||||||||||||||||
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
Cornea |
Iris |
Conj |
IS |
A |
|
||||||||||||||
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
O |
A |
I |
R |
C |
|
||||||||||||||
44208 |
0 |
0 |
0 |
1* |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0~~ |
0 |
0 |
1* |
2 |
0 |
0 |
|
|||||||
O: Opacity; A: Area; I: Iritis; Conj: Conjunctivae; R: Redness; C: Chemosis; FE: Fluorescein Exam; IS: Intensity of Staining * Discharge - clear ** Discharge - thick, white mucous ^ Discharge - red-tinged ~ Irreversible – Pannus ~~ Irreversible – ulceration of conjunctival membrane with scarring @ Difficult or unable to read due to swelling |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance is considered to be corrosive to the eye.
- Executive summary:
Eye irritation was determined in a study performed according to OECD 405 and in compliance with GLP criteria. In this study, 3 New Zealand White rabbits (male and female) were exposed to 0.1 mL (100 mg) of test substance in the left eye. The eyes were rinsed within two hours of instillation as the test substance was not removed from the eye by physiological mechanisms. The eyes were examined at 1, 24, 48 and 72 hours on the basis of effects on the cornea, iris, conjunctivae redness and chemosis. Animals were observed daily for clinical signs of toxicity. Animals were weighed at study start and on Days 6 and 17, when applicable. All animals gained weight and no systemic signs of toxicity were observed during the course of the study. The test substance caused irreversible change in the eye in the form of pannus and conjunctival ulceration/scarring and is therefore considered to be corrosive to the ocular tissue.
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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