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EC number: 700-351-6 | CAS number: -
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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:
- 03 November 2008 - 13 November 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid
- Details on test material:
- - Appearance/physical state: Black lumps
- Storage conditions: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan France SARL, Gannat, France.
- Conditions: Controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21 +/- 3C, a relative humididty of 30-70% and 12 hours artificial fluorescent light and 12 hours darkness per day.
- Housing: Individually in labelled cages with perforated floors (Ebeco, Germany) dimensions 67 x 62 x 55 cm and shelters (Ebeco, Germany) dimensions 40 x 32 x 23 cm.
- Acclimatisation: At least five days before the start of treatment under laboratory conditions.
- Diet: Pelleted diet for rabbits (K-H from SSNIFF Spezialdiatenj GmbH, Soest, Germany (approximately 100 g per day) and hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water: Free access to tap water.
- Results of analysis for each batch of diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the integrity of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Undiluted
- Amount(s) applied (volume or weight with unit): 62.1 mg (range 61.8-62.2 mg) of the test substance (a volume of approximately 0.1 mL)
- Duration of treatment / exposure:
- 72 hours in one animal (sentinel) and 24 hours in the other two animals.
- Observation period (in vivo):
- approximately 1, 24, 48, and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3 Males
- Details on study design:
- STUDY DESIGN
- An in vitro study was considered but a negative result was anticipated and this would need to have been confirmed by an in vivo study.
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel).
- The two other animals were treated in a similar manner one wek later after considering the degree of eye irritation observed in the first animal.
TREATMENT
- Animals were treated by instillation of 62.1 to 62.2 mg test substance (0.1 mL) into the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball.
- The lids were then gently held together for about one second to prevent loss of the test substance.
- The other eye remained untreated and served as the reference control.
- Immediately after the 24 -hour observation, a solution of 2 % fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
- Immediately after fluorescein examination on Day 2, the treated eye of two animals was rinsed with tepid tap water (approximately 50 mL) to remove residual test substance using a velocity of flow which did not affect the eye.
- For reference control the other eye was also rinsed.
- After the final observation, the animals were sacrificed by intravenous injection of phenobarbital (Euthesate; Ceva Sante Animale BV, Naaldwijk, The Netherlands).
OBSERVATIONS
- Mortality/viability: Twice daily
- Toxicity: At least once daily
- Body weight: Day of treatment (prior to instillation) and at termination
- Irritation: The eyes of each animal were examined at approximately 1, 24, 48 and 72 hours after instillation of the test substance. Irritation scores according to the attached scheme were recorded together with a description of other (local effects).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 4
- Irritant / corrosive response data:
- - Individual eye irritation scores are presented in Table 1 (attached).
- Instillation of approximately 62 mg of test item (0.1 mL) into one eye of each of three rabbits resulted in irritation of the conjuntivae (redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours).
- No iridial irritation or corneal opacity was observed and treatment of the eyes with 2 % fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
- There was no evidence of ocular corrosion.
Any other information on results incl. tables
- No staining of (peri) ocular tissues by the test substance was observed. Remnants of the test substance were present in the eye and on the outside of the eyelids in all animals on Day 1. On Day 2, test substance remnants were still present in the eye in two animls and on the outside of the eyelids in one animal.
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Instillation of approximately 62 mg of test item (a volume of approximately 0.1 mL) into the eye of each of three rabbits resulted in irritation of the conjunctivae which consisted of redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours. No iridial or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. Based on these results the test item does not have to be classified for eye irritation according to EC criteria (Council Directive 67/548/EEC) or the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007).
- Executive summary:
GUIDELINE
The study was conducted in accordance with OECD No 405 (2002) "Acute Eye Irritation/Corrosion", EU No Method B.5 (2008) "Acute Toxicity: Eye Irritation/Corrosion", EPA OPPTS 870.2400 (1998) "Acute Eye Irritation" and JMAFF guidelines (2000) including the most recent revisions.
METHODS
Animals were treated by instillation of 62.1 to 62.2 mg test substance (0.1 mL) into the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Immediately after the 24 -hour observation, a solution of 2 % fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Immediately after fluorescein examination on Day 2, the treated eye of two animals was rinsed with tepid tap water (approximately 50 mL) to remove residual test substance using a velocity of flow which did not affect the eye. For reference control the other eye was also rinsed. After the final observation, the animals were sacrificed by intravenous injection of phenobarbital.
RESULTS
Instillation of approximately 62 mg of test item (a volume of approximately 0.1 mL) into the eye of each of three rabbits resulted in irritation of the conjunctivae which consisted of redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours. No iridial or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
CONCLUSION
Based on study results the test item does not have to be classified for eye irritation according to EC criteria (Council Directive 67/548/EEC) or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007).
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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