Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD 405 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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
Type:
Constituent
Details on test material:
- NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach a. Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.90 - 3.24 kg
- Housing: single in stainless steel wire mesh cages with grating, floor area: 3,000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day).
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes.
Amount / concentration applied:
Application volume: 0.1 mL (unchanged).
Duration of treatment / exposure:
72 h, since no wash out was done.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 female animals.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was performed

SCORING SYSTEM: as described in OECD Guideline 405 (cornea opacity, conjunctivae redness, chemosis and iris).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: animal #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
iris score
Basis:
other: animal #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
chemosis score
Basis:
other: animals #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 1 - 0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 0 - 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the test conditions chosen and considering the described findings Asta-C15-acetal does not give indication of an irritatnt property to the eye. Thus, classification is not warranted according to Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC.