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EC number: 700-002-8 | CAS number: 1333483-07-0
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, guideline compliant
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
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(1E)-2-(2,4-diamino-6-hydroxypyrimidin-5-yl)diazen-1-yl]-5-methylbenzene-1-sulfonic acid
- EC Number:
- 700-002-8
- Cas Number:
- 1333483-07-0
- Molecular formula:
- C11H12N6SO4
- IUPAC Name:
- 2-[(1E)-2-(2,4-diamino-6-hydroxypyrimidin-5-yl)diazen-1-yl]-5-methylbenzene-1-sulfonic acid
- Details on test material:
- Physical State: solid
Expiry Date: 31.12.2009
Storage: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: Healthy New Zealand White Rabbits
Strain: Crl:KBL (NZW)
Source: Charles River Deutschland, D-88353 Kisslegg
Sex: female
Body weight at the beginning of the study: 4.5, 4.5, 3.9 kg
Age at the beginning of the study: approximately 13 weeks old
Number of animals: 3
The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A dose of 0.1 g of the test item was applied to the test site.
- Duration of treatment / exposure:
- The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
- Observation period (in vivo):
- The animals were observed for 72 hours after dosing.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test item was ground to a fine powder in a mortar with the help of a pestle.
Approximately 24 hours before the test and immediately prior to the application both eyes of the test animals were examined. A health inspection was performed to ensure the good state of health of the animals. None of the animals showed eye irritation, ocular defects, or pre-existing corneal injury.
The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye using the procedure described. In order to confirm the response, two additional animals were treated in the same manner.
The animals were observed for 72 hours after dosing.
The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored and recorded according to the grades in the table below. For calculation only the 24 h, 48 h and 72 hour readings were used. At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo, Lot H 801, expiry date: 01/2010).
Individual reactions of each animal were recorded at each observation time. Nature, severity and duration of all lesions observed were described. For calculation only the 24 h, 48 h, 72 hour readings were used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Under the conditions of the present study, single ocular instillation of the test item to rabbits at a dose of 0.1 g produced slightly irritant effects, which were fully reversible within 72 hours in animals no. 1 and 2 and within 48 hours in animal no. 3.
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed. There were no significant body weight changes during observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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