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EC number: 701-371-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- 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
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- Nanomaterial agglomeration / aggregation
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- Nanomaterial Zeta potential
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- 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
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- Sediment toxicity
- Terrestrial toxicity
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- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study, sufficient for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500, 41
- Principles of method if other than guideline:
- This test was used for eye irritation test before OECD guideline 405 was established. It is generally similar to the Draize test, with the following deviations: 100 mg of the test substance was applied to the right eye (OECD recommends a volume of 0.1 ml), 6 animals were used (OECD: 3); observation period was 7 days (OECD: 21).
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): Heliogengruen D 8730 (fest)
- Analytical purity: ca. 98 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: at the start of the test, the animals weighed ca. 2.5 kg
- Housing: Rabbits were kept in individual cages (540 x 360 x 315 mm) or in restraining devices
- Diet: 200 g of food per animal per day (Granules Lapin "entretien", Sanders)
- Water: softened and filtrated water ad libitum, automatically given
ENVIRONMENTAL CONDITIONS
- Temperature (°C): minimum 20 °C
- Air changes: ventilation (renewal of air 12 times per hour )
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye was treated with 50 mg talcum powder and served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg
- Concentration: undiluted - Duration of treatment / exposure:
- 24 h; the substance was not washed out.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 100 mg of the undiluted test substance was applied to the right conjuntival sac of 2 Vienna White rabbits. The left eye was treated with 50 mg talcum powder and served as control. The substance was not washed out.
Ocular reactions were recorded at 1 h, 24 h, 48 h, 72 h, 96 h and 7 days after instillation using a scoring system, which is convertible into the current OECD Draize scheme. For the evaluation, the scores given in the raw data were converted to Draize scores. The reading time points used for assessment were 24, 48 and 72 hours after application.
Observations of the condition of the cornea were made with the naked eye and also with the aid of an ophtalmoscope of Heine.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0.11
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- The following effects observed were observed, but were completely reversible within 72 hours:
- Test animals showed slight conjunctiva chemosis and redness, which were completely reversible in 5/6 animals within 48 hours;
- Iris congestion was also observed in 3/6 animals and was also completely reversible within 48 hours in 2 of the animals concerned;
- The cornea was slightly affected in 1/6 animals at 24 h only.
Any other information on results incl. tables
Table 1: Eye irritation parameters according to the method of Draize
Reading time point |
Animal 1, treated eye (right) |
||||
Conjunctiva Chemosis |
Conjunctiva Redness |
Iris score |
Cornea score |
Additional findings |
|
1 h |
1 |
1 |
1 |
0 |
|
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Reading time point |
Animal 2, treated eye (right) |
||||
Conjunctiva Chemosis |
Conjunctiva Redness |
Iris score |
Cornea score |
Additional findings |
|
1 h |
1 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Reading time point |
Animal 3, treated eye (right) |
||||
Conjunctiva Chemosis |
Conjunctiva Redness |
Iris score |
Cornea score |
Additional findings |
|
1 h |
1 |
1 |
0 |
0 |
|
24 h |
2 |
1 |
1 |
1 |
discharge |
48 h |
0 |
1 |
1 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Reading time point |
Animal 4, treated eye (right) |
||||
Conjunctiva Chemosis |
Conjunctiva Redness |
Iris score |
Cornea score |
Additional findings |
|
1 h |
1 |
1 |
0 |
0 |
|
24 h |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Reading time point |
Animal 5, treated eye (right) |
||||
Conjunctiva Chemosis |
Conjunctiva Redness |
Iris score |
Cornea score |
Additional findings |
|
1 h |
1 |
0 |
1 |
0 |
|
24 h |
1 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Reading time point |
Animal 6, treated eye (right) |
||||
Conjunctiva Chemosis |
Conjunctiva Redness |
Iris score |
Cornea score |
Additional findings |
|
1 h |
1 |
0 |
0 |
0 |
|
24 h |
1 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
96 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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.
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