Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2007
Bibliographic source:
IUCLID4 data set, 2007

Materials and methods

Test guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of 100% substance
Duration of treatment / exposure:
72h not rinsed
Observation period (in vivo):
6d
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.3 - 5.3 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Amount of substance instilled: 0.1 g
- Postexposure observation period: 6 days
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, and 6 days after
treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data
sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual
inspections

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
3.75
Max. score:
110
Reversibility:
fully reversible within: 6d
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.94
- Conjunctivae (Chemosis): 0.11
- Overall irritation score: 3.75/110
REVERSIBILITY: complete in 6 days
OTHER EFFECTS: distinct redness in nictitating membranes of all animals
at 24 hours only

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU