Registration Dossier

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
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1-chloro-4-propoxythioxanthone was standard quality material HPLC assay >98%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
All weighed 3.2 to 3.5 kgs and were approx 14 to 15 weeks old. all were housed individually in metal cages with perforated floors.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
63mg
Duration of treatment / exposure:
one application
Observation period (in vivo):
observed at 1hr and daily for 4 days.
Number of animals or in vitro replicates:
3
Details on study design:
Information from migrated NONS file, as per inquiry 06-0000020508-70-0000, permission to refer granted by ECHA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hr after administration
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1 day
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1 day
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 day
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 day
Irritant / corrosive response data:
A single instillation of the test material into the eye of the rabbit elicited mild conjunctival inflamation only. All reactions had resolved one or two days after instillation.

Any other information on results incl. tables

Information from migrated NONS file, as per inquiry 06-0000020508-70-0000, permission to refer granted by ECHA

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance EC No 415-890 -1 does not require labelling with risk phrase "Irritating to the Eyes"
Executive summary:

The substance EC No 415 -890 -1 is non-irritating to the eyes.