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: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity 99.9%, undiluted

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
The substance was not washed out.
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
1 male

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 + 48 + 72 hours
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 + 48 +72 hours
Score:
0.3
Max. score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 +48 +72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 + 48 + 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 15 days

Any other information on results incl. tables

corneal opacity, degree 4, staphyloma, study discontinued
after 15 days because severe irritation

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Classification: risk of serious damage to eyes
Executive summary:

In an eye irritation study according to OECD 405, 0.1 ml of the undiluted test substance was instilled into the conjunctival sac of one eye of a White Vienna rabbit. The eye was not washed out. The animal was observed for 15 days. After 1 hour, erythema, edema as well as corneal opacity were observed. The mean value of the scores after the 24, 48 and 72 hour reading for erythema, edema, iris and corneal opacity were calculated to be 2.0, 2.0, 0.3, and 1.0, respectively. The observed changes were not reversible within 15 days. Due to the observed effects metylpentynol has the potential to seriously damage the eyes.