1,2-dichloro-4-(trichloromethyl)benzene

Eye irritation

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,2-dichloro-4-(trichloromethyl)benzene

EC Number:

235-869-7

EC Name:

1,2-dichloro-4-(trichloromethyl)benzene

Cas Number:

13014-24-9

Molecular formula:

C7H3Cl5

IUPAC Name:

1,2-dichloro-4-(trichloromethyl)benzene

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 3 out of 3

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: 3 out of 3

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 3 out of 3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3 out of 3

Time point:

24/48/72 h

Score:

0

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:

other: CLP criteria not met

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 -Dichlorbenzotrichloride 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.