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EC number: 434-850-2 | CAS number: 1680-31-5
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Irritation / corrosion
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![](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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-08-17 to 1999-08-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- January 1997
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg, Germany
- Weight at study initiation: 2.3 - 2.4 kg
- Diet: rabbit diet "Altromin 2123" (supplier: Altromin, D-32791 Lage, Lippe, Germany), ad libitum.
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature:20 °C ± 3°C
- Humidity:55 % ± 15 %
- Air changes: 10 times/hour
- Photoperiod: cycle of 12 hours light and 12 hours darkness. Light was on from 06 to 18 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Only the left eye was treated. The right eye remained untreated and served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL of test item - Duration of treatment / exposure:
- 0.1 mL ofthe test article was placed in the left eye ofthe rabbits by gently pulling the lower Iid away from the eyeball to form a cup into which the test article was dropped. The Iids were then gently heldtagether for 1 second.
- Observation period (in vivo):
- The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. The eyes were also examined 48 and 72 hours after the treatment.
- Number of animals or in vitro replicates:
- three females
- Details on study design:
- The day before testing both eyes of the animals were examined with a hand held inspection lamp fitted with white and UV -light and magnifying glass with 2 x magnification to ensure there were no defects or irritation. The examination was performed before and after instillation of Fluorescein.
After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 mL 0.9 % sodium chloride solution the eyes were examined again using UV -light to detect possible corneal damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 0, 24,48,72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean value
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean value
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean value
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: mean value
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: mean value
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: mean value
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean value
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean value
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean value
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean value
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean value
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 0, 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean value
- Irritant / corrosive response data:
- After 72 hours all animals were free of any signs of eye irritation.
Any other information on results incl. tables
After 24 hours animal no. 1 and no. 2 showed some conjunctival vessels definitely injected. Some conjunctival vessels definitely injected and some swelling above normal was observed in animal no. 3. After 48 hours animal no. 1 showed some conjunctival vessels definitely injected. Animal no. 2 and no. 3 did not show any signs of eye irritation. After 72 hours all animals were free of any signs of eye irritation. Under the experimental conditions described the test item caused no evidence of skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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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