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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 16 March to 06 July 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 405 in compliance with GLP. Analytical certificate not included in study report.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna Ltd., UK
- Housing: Macrolon Type III cages
- Diet (e.g. ad libitum): Standard Ssniff K4 diet (Soest/Westfalen GmbH)
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye treated, the other left untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 h, after which eye was rinsed with saline solution.
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with saline solution
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No effects reported on cornea, iris or conjunctiva at any of the timepoints.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the substance was not irritating to eyes.
Executive summary:

A study was conducted to determine the eye irritation potential of the substance in rabbit according to OECD Guideline 405. 100 µl of undiluted substance were instilled into one eye of each of 3 rabbits, then rinsed after 24 hours with saline solution. The other eye was left untreated and served as control. Effects on cornea, iris and conjunctivae were evaluated after 1, 24, 48 and 72 h, as well as after 7, 14 and 21 d according to the Draize scoring system. Other effects were also recorded. No symptoms were observed at any of the time points. Based on these findings, the substance was considered to be non-irritating to eyes under the conditions of the study (Märtins T, 1988).