Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May. 14, 1979 to June 5, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
treated eye was rinsed with physiological saline in 3 of the 6 rabbits
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland
- Age at study initiation: Not reported
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet: Standard rabbit food, NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 14 hrs dark/10 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure: 30 seconds for rinsed eyes, substance not removed at all for unrinsed eyes
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits, the treated eye was flushed with 10 mL of physiological saline
- Time after start of exposure: Approximately 30 seconds after treatment (for 3 of the 6 rabbits)

SCORING SYSTEM: Irritation reactions were assessed according to the same scale provided in the OECD guideline, with the exception of 1 criteria (additional changes to discharge were included in addition to the other parameters).

TOOL USED TO ASSESS SCORE: Eye irritation was appraised with a slit lamp on day 1, 2, 3, 4, and 7 for each individual rabbit.

Calculation of the primary eye irritation index:
The mean reaction scores for cornea, iris, and conjunctiva observed after 1, 2, 3, 4, and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed and rinsed eyes, respectively. The conjunctivae score includes observations for redness, chemosis, and discharge.

Index:
0 - 10 = minimal
11 - 25 = slight
26 - 55 = moderate
56 - 84 = marked
above 84 = extreme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
unrinsed or rinsed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
unrinsed or rinsed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
unrinsed or rinsed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Remarks:
unrinsed or rinsed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
All scores recorded for all animals at all tim points were zero. The primary irritation index for unrinsed or rinsed eyes was equal to 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this experiment the test material was found to cause no irritation when applied to the rabbit eye mucosa.