Registration Dossier
Registration Dossier
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EC number: 616-436-5 | CAS number: 77098-07-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed according to established guidelines and good laboratory practices.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA 560/6-82-001
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate with 2,2'-oxy-diethanol and 2-epoxypropane
- EC Number:
- 616-436-5
- Cas Number:
- 77098-07-8
- Molecular formula:
- Ester product of C8 H2 Br4 O4 with C4 H10 O3 and C3 H8 O2 and condensation products, thereof.
- IUPAC Name:
- Reaction products of 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate with 2,2'-oxy-diethanol and 2-epoxypropane
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six adult rabbits (3 males/3 females) were acclimated 5 days prior to test initiation. Housed individually. Provided food (Wayne Rabbit Ration) and tap water ad libitum. Light cycle: 12:12 h light:dark. Eyes examined for normality prior to inclusion on test.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal (left eye) served as its own control.
- Amount / concentration applied:
- 0.1 ml to the right eye
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 1, 24, 48 and 72 post-dosing. Grades of ocular reaction recorded at each examination.
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- Grading as per Draize, J.H. (1965) Appraisal of the Safety of Chemicals in Foods, Drugs adn Cosmetices - Dermal Toxcity, pg 49-52. Asociation of Food adn Drug officials of the US, Topeka, KS, and Draize, J.H. (1959), appraisal of Chemicals in Foods, Drugs adn Cosemetics, pg. 36-45. Association of Food and Drug Officials of the US, Austin, TX, and Draize, J.H., et al., (1944) J. Pharm. Exp. Ther. 82:377-390.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 0
- Remarks:
- min
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 0
- Remarks:
- min
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.056
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48
- Remarks:
- h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 0
- Remarks:
- min
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No positive ocular scores were recorded. The test article was determined not to be an eye irritant.
Any other information on results incl. tables
A positive reaction was considered as: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of hte normal luster), inflammation of the iris (other than a slight deepening of the rugae or light hyperemia of the cirumcorneal blood vessels), or an obivous swelling in the conjunctivae (excluding the corea and iris) with partial eversion of the eyelids adn a diffue crmoson color wiht individual vessels not easily discernible.
A positive test was defined as one with 4 or more of the animals exhibiting a positive reaction. A negative study was one with 1 or no animals exhibiting a positive reaction.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- Not an eye irritant.
- Executive summary:
No positive ocular scores were recorded. The test article was determined not to be an eye irritant.
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