2,3-dichlorophenoxyacetic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study had been performed in accordance with OECD Guideline No.: 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,3-dichlorophenoxyacetic acid

EC Number:

221-022-9

EC Name:

2,3-dichlorophenoxyacetic acid

Cas Number:

2976-74-1

Molecular formula:

C8H6Cl2O3

IUPAC Name:

(2,3-dichlorophenoxy)acetic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Dichlorophenoxyacetic acid
- Physical state: light beige powder
- Purity test date: 26. 09. 2005
- Lot/batch No.: 10
- Expiration date of the lot/batch: : 07. 2006
- Storage condition of test material: at room temperature, protected from light

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder: Ferenc Sándor, address: Császár street 135, Kartal, H-2173, Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: 2584-2903 g
at study termination: 3015-3234 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, PURINA Base - Lap gr. diet for rabbits (produced by AGRIBRANDS Europe)
- Water (e.g. ad libitum): ad libitum, tap water (for human cosumption) from automatic self supplying watering system
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12-12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the contralateral eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item Dichlorophenoxyacetic acid in pure state in a single dose

Duration of treatment / exposure:

The eyes of the test animals were not washed out after the application of the test item.

Observation period (in vivo):

14 days (1, 24, 48, 72 hours and then one and two weeks after the treatment)

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
The eyes of the test animals were not washed out after the application of the test item.

SCORING SYSTEM:
Draize (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2, 3

Time point:

other: 1, 24, 48, 72 hours after the treatment

Score:

0 - 18

Max. score:

20

Reversibility:

fully reversible within: 2 weeks

Results 2

Irritation parameter:

iris score

Basis:

animal: 1, 2, 3

Time point:

other: 1, 24, 48 and 72 hours after the treatment

Score:

0

Max. score:

10

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal: 1, 2, 3

Time point:

other: 1, 24, 48 and 72 hours after the treatment

Score:

0 - 30

Max. score:

80

Reversibility:

fully reversible within: 2 weeks

Irritant / corrosive response data:

One hour after treatment the vessels were diffuse beefy red (score 3) in two animals (5140, 5135), as well as were diffuse and the individual vessels were not easily discernible (score 2) in one animal (5129).
In all animals some swelling above normal was observed (score 1) at this time.
The discharge moistened lids and hairs on considerable area around the treated eye (score 3) were found in all animals.
In two animals (5140, 5135) diffuse areas of opacity were observed on the cornea, but the details of iris were clearly visible (score 1). In animal No.: 5129 easily discernible translucent areas of the cornea were observed and the details of iris were slightly obscured (score 2). The area of cornea involved was greater than three quarters, up to the whole area (score 4).

There were no effects observed in the iris alterations during the study period.

24 hours after treatment in all animals the vessles were diffuse beefy red (score 3) and the discharge with moistening of the lids and hairs on considerable area around the eye (score 3) was found.
The conjunctival swelling with lids about half closed (score 3) was seen in animal No.: 5129, conjunctival sweeling with partial eversion of the lids (score 2) was observed in animal No.: 5135, as well as swelling above normal (score 1) was found in animal No.: 5140.
In two animals (5135, 5129) easily discernible translucent areas of the cornea were observed and the details of iris were slightly obscured (score 2). In animal No.: 5140 diffuse areas of opacity were observed on the cornea, but the details of iris were clearly visible (score 1). The area of cornea involved was greater than three quarters, up to the whole area (score 4).

48 hours after treatment
The eye irritation symptoms became slighter at this time. In all animals the irritation of conjunctive decreased (score 2) when compared to the previous observation.
Discharge was not observable in the treated animals.
In two animals (5135, 5129) conjunctival sweeling with partial eversion of the lids (score 2) was observed.
In animal No.: 5129 the degree and extension of cornea opacity did not change when compared to the previous observation. In two animals (5140, 5135) diffuse areas of opacity were observed on the cornea, but the details of iris were clearly visible (score 1). Area of cornea involved was greater than three quarters, up to the whole are (score 4).

72 hours after treatment redness of the conjunctivae and corneal alteration did not change compared to the previous observation.
In two animals (5135, 5129) some swelling above normal was observed (score 1).

One week after the treatment in two animals 8No.: 5135, 5129) were found corneal alterations. Diffuse areas of opacity were observed on the cornea but the details of iris were clearly visible (scores 1). The area of cornea involved was greater than three quarters, up to the whole areas (scores 4). However, in animal No.: 5135 some blood vessles were hyperaemic (score 1) occurred.
The animal No.: 5140 became free of irritation symptoms by this time.

Two weeks after the treatment the study was terminated, since no primary irritation symptoms remained.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item DICHLOROPHENOXYACETIC ACID, applied to the rabbit's eye mucosa, caused conjunctival and corneal irritant effects, fully reversible within two weeks. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.