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EC number: 407-870-4 | CAS number: 97384-48-0 CITROWANIL B
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP; Study according to OECD-Guideline April 1981 lack of data on the purity / quality of the sample tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Additional observation and scoring of lacrimation
- GLP compliance:
- yes
Test material
- Reference substance name:
- CITROWANIL B M 2/585 Nr. 4, clear fluid
- IUPAC Name:
- CITROWANIL B M 2/585 Nr. 4, clear fluid
- Details on test material:
- Citrowanil B
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Five adulthealth albino rabbits (tattooed New Zealands) were used for the procedure, body weights between 2.8 and 3.3 kg.
The animals were housed in individual cages and were fed with a standard laboratory diet for rabbits (Altromin/Lage) (beside 16 hours before application) and were watered ad libitum.
The room temperature was kept constantly at 18 °C +/- 2 °C, the relative humidity 50 - 60 % and daily illumination time was 12 hours.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the warmed undiluted substance was applicated into the conjunctival pouch of the left eye. The right one stayed untreated and served as control.
- Duration of treatment / exposure:
- The treated eye was not cleaned.
- Observation period (in vivo):
- 7 days
Readings of eye alterations were made after 1, 2, 4, 8, 24 hours and 2, 3, 4, 5, 6, 7 days - Number of animals or in vitro replicates:
- 5
- Details on study design:
- For the test of the toxicity of materials to the eye mucosa serves the verification on noxious effects to cornea, iris, conjunctiva bulbi and palpebrae in the species rabbit according to the evvaluation code for eye lesions of Draize, 1958.
Before and after the test the eyes of all animals were examined with fluorescin 2 per cent under UV.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 and 2 hours
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: maximum single score: 1, only conjuctiva
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: maximum single score: 1, only conjuctiva
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 8 hours
- Score:
- 3.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: maximum single score: 1, only conjuctiva
- Irritant / corrosive response data:
- Only slight irritating effects (score 1) were observed in the conjunctivae (reddening, chemosis and lacrimation) till 8 hous after administration in all animals. 24 hours till 7 days after administration not any sign of irritation was observerd.
For details see Tables in "Any other information on results incl. tables".
Any other information on results incl. tables
Individual values of ocular lesions |
|||||||||||||
Animal |
|
|
hours |
days |
|||||||||
No. |
|
|
1 |
2 |
4 |
8 |
24 |
2 |
3 |
4 |
5 |
6 |
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
A |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
C |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
A |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
C |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
A |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
C |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
A |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
C |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
A |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
B |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
C |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary of ocular lesions: |
|||||||||||
Animal |
hours |
days |
|||||||||
No. |
1 |
2 |
4 |
8 |
24 |
2 |
3 |
4 |
5 |
6 |
7 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
6 |
6 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
6 |
6 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
6 |
6 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
6 |
6 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
6 |
6 |
4 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
6.0 |
6.0 |
3.3 |
3.2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The compound CITROWANIL B M 2/585 Nr. 4 can be classified as "non irritant" to eyes.
- Executive summary:
The compound CITROWANIL B M 2/585 Nr. 4 was tested in a primary eye iritation test in rabbit eye. The substance was used undiluted.
Under the conditions of the experiment it was found:
Till 8 hours p.a. very slight conjuctival changes were observed.
The compound CITROWANIL B M 2/585 Nr. 4 can be classified as "non irritant" to eyes.
There is no objection for contact in the near of human eyes.
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