Registration Dossier
Registration Dossier
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EC number: 431-230-3 | CAS number: 202483-62-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start: 02 February 1998 Completed: 05 February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study performed according OECD and or EC guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Identification: TS-2863
Description: White solid
Batch: 85-36
Purity: 99.8%
Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Expiry date: 18 December 1998
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- ca 46mg
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 3 days after
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 3 days after
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 3 days after
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 1 day after
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 1 day after
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 1 day after
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 1 day after
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 1 day after
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 1 day after
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Iridic irridation grade 1 was observed in all animals and had resolved within 24 hours. Irritation of the conjunctivae was seen in all animals and consisted of redness, chemosis and discharge. The irritation had completely resolved between 24 and 72 hours. Slight dulling of normal lustre (opacity grade 0) was apparent in one animal 1 hour after instillation, which had resolved within 24 hours. Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion. - Other effects:
- No staining of peri-ocular tissues by the test substance was observed.
Remnants of the test substance were present in the eyes of all animals at 1 hour after instillation of the test substance.
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
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TS-2863 does not have to be classified and has no obligatory labelling requirements for eye irritation.
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