Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study details, but recognised guideline followed. Study referenced in EU Risk Assessment Report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
0.1 mL of undiluted test material (purity >99%) instilled into the eyes of each of 3 rabbits.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
>99% purity

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
As guideline

Results and discussion

In vivo

Irritant / corrosive response data:
Mild conjunctival irritation noted; oedema grade 1 in all animals on day 1, conjunctival redness grade 1 in all animals for 1-2 days.
All effects had reversed 3 days after instillation.
No corneal damage or irideal inflammation noted.

Any other information on results incl. tables

No further data available.

Applicant's summary and conclusion

Conclusions:
Not irritating