Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Observation period could have been extended to fully observe reversal of effects.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.5
Principles of method if other than guideline:
Observation period was only 7 days.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Tradename Lial 111 C6-12 alcohols Type A

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
unspecified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: direct observation and UV lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.11
Max. score:
1.3
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
- Conjunctivae (Redness): individual scores all 2 (group mean score 2)
- Conjunctivae (Chemosis): individual scores 4 rabbits 1, 2 rabbits 1.3  (group mean score 1.11)

REVERSIBILITY: Conjunctival redness and chemosis persisted to 7 days.  Individual scores for redness were 4 rabbits grade 1, 2 rabbits 0 
(group  mean score 0.66) and for chemosis wer 3 rabbits grade 1, 3 at 0 (group  mean score 0.5)
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Using EU criteria Lial 111 is a category 2 irritant based on 24+48+72 hour scores for conjunctival redness of 2 in all rabbits and persistence to 7 days. The evidence of conjunctival irritation at 7 days was noticeably less than at 72 hours.

Classification: not irritating