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Toxicological information

Eye irritation

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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:
1998
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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