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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:
June 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: in accordance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3, 4- Dichlorbenzotrichlorid (Intermediate of SLA 3992)
- Physical state: colorless liquid
- Analytical purity: 98.6-99.3 %
- Lot/batch No.: 16001/89
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: room temperature, in the dark.
-pH: 3.8 (2% in 0.9% NaCl-solution)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd, England
- Age at study initiation: adult
- Housing: individually caged in stainless steel cages, in one room
- Diet: standard diet "Ssniff k4", approx 100-120 g per animal and day
- Water : drinking tap water
- Acclimation period: at least 14 days before the test start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): approx 50%
- Air changes (per hr): approx 10
- Photoperiod (hrs dark / hrs light): 12 hours artificial illumination

IN-LIFE DATES: From: June 20, 1989 To: June 20, 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other untreated eye served as control
Amount / concentration applied:
100 µL test substance
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h, 7 d
Number of animals or in vitro replicates:
3
Details on study design:
An application volume of 100 µL test substance was instilled into the conjunctival sac of one ye of each of the three rabbits after gently pulling the lower lid away from the eyeball. the lids were gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test substance.
The examinations of cornea iris and aqueous humour were facilitated by use of optical instruments (e.g. hand slit-lamp). To define epithelial damage, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hrs after application of the test substance.. the eye was then rinsed with physiological NaCl solution in order to remove excess and nonabsorbed fluorescein. Evaluation was performed by means of UV (area) and diffuse white illumination (intensity) according to McDonald and Shadduck, modified.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: cornea, fluorescein, iris conjunctivae, aqueous humour discharge
Basis:
animal #1
Time point:
other: 7 d
Score:
0
Irritation parameter:
other: cornea, fluorescein, aqueous humour discharge
Basis:
animal #2
Time point:
other: 7 d
Score:
0
Irritation parameter:
other: cornea, fluorescein, iris conjunctivae, aqueous humour discharge
Basis:
animal #3
Time point:
other: 7 d
Score:
0
Irritation parameter:
iris score
Remarks:
(iris conjunctivae)
Basis:
animal #2
Time point:
other: 7 d
Score:
0.3
Remarks on result:
other: in terms of redness
Irritant / corrosive response data:
not irritant to the eye

Any other information on results incl. tables

For the calculation, the Draize scores approx 24, 48 and 72 hours after application were used.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: interpretation was based on the nature, intensity, and reversibility of the observed responses.
Conclusions:
This study reveals that the test substance can be regarded as "not irritating" to the eye.
Executive summary:

A study for irritant/corrosive potential on the rabbit's eye was conducted with 3,4 -Dichlorbenzotrichlorid in accordance with OECD Guideline for Testing of Chemical n. 405. In respect to the OECD Interpretation Guides results were interpreted in conjunction with the nature, intensity, and reversibility of the observed responses.

After an acclimation period of at least 14 days before the test start, an application volume of 100 µL test substance was instilled into the conjunctival sac of one ye of each of the three rabbits after gently pulling the lower lid away from the eyeball. the lids were gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test substance.The examinations of cornea iris and aqueous humour were facilitated by use of optical instruments (e.g. hand slit-lamp). To define epithelial damage, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hrs after application of the test substance.. the eye was then rinsed with physiological NaCl solution in order to remove excess and nonabsorbed fluorescein. Evaluation was performed by means of UV (area) and diffuse white illumination (intensity) according to McDonald and Shadduck, modified.

The test substance resulted to be not irritant to the rabbit's eye.