Sodium 2,4-dichlorophenoxyacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

04 Dec 1997 - 11 Dec 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions: 72 h time point not evaluated, observation time 7 days

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1987)

Deviations:

yes

Remarks:

, 72 h time point not evaluated, observation time 7 days

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethylammonium 2,4-dichlorophenoxyacetate

EC Number:

217-915-8

EC Name:

Dimethylammonium 2,4-dichlorophenoxyacetate

Cas Number:

2008-39-1

IUPAC Name:

N-methylmethanaminium (2,4-dichlorophenoxy)acetate

Details on test material:

- Name of test material (as cited in study report): Aminopielik 720 SL
- Physical state: light brown solution with characteristic smell
- Analytical purity: 720 g/L 2,4-D

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rabbit Breeding, Balice, Poland
- Age at study initiation: 4 months (mean)
- Weight at study initiation: 3.1 kg (mean)
- Housing: individually in cages (80 x 80 x 60 cm3)
- Diet: granulated standard food and hay, both ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40 - 80
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

other: unchanged and a 1% water solution

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 application

Observation period (in vivo):

1, 24, 48 h and 7 days

Number of animals or in vitro replicates:

Only one animal was tested for the undiluted substance as it is suggested to be corrosive to the eye
3 animals were tested with the 1% solution

Details on study design:

SCORING SYSTEM: The irritation was scored according to the gradation given in guideline OECD 405 (Draize score).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: average of 24 and 48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Remarks on result:

other: undiluted test substance

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: average of 24 and 48 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks:

within 7 days

Remarks on result:

other: undiluted test substance

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: average of 24 and 48 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks:

within 7 days

Remarks on result:

other: undiluted test substance

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: average of 24 and 48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: undiluted test substance

Irritant / corrosive response data:

Aminopielik 720 SL caused irritant effects in cornea, iris and conjunctivae at all time points of examination. Opacity covered nearly the whole area of the cornea. The iris was not discernible; it was congested and did not react to light. In the conjunctivae, diffuse beefy red hyperemia was observed and the lids were swollen about half closed. After 48 h necrosis of the mucosa and after 7 days leukoma were stated.
The 1% water solution did not cause any effects.

Any other information on results incl. tables

Table 1a: Aminopielik 720 SL - Evaluation of eye irritation

Rabbit No.	Part of the eye	A	B	C	A	B	C	A	B	C	A	B	C
1	Cornea	3	4		3	4		3	4		4	4
	Iris	2			2			2			2
	Conjunctivae	3	3	3	3	3	3	3	3	3	3	3	3

Table 1b: Aminopielik 720 SL 1% solution – Evaluation of the eye irritation

Rabbit No.		A	B	C	A	B	C	A	B	C	A	B	C
1	Cornea	0	0		0	0		0	0		0	0
	Iris	0			0			0			0
	Conjunctivae	0	0	0	0	0	0	0	0	0	0	0	0
2	Cornea	0	0		0	0		0	0		0	0
	Iris	0			0			0			0
	Conjunctivae	0	0	0	0	0	0	0	0	0	0	0	0
3	Cornea	0	0		0	0		0	0		0	0
	Iris	0			0			0			0
	Conjunctivae	0	0	0	0	0	0	0	0	0	0	0	0

Cornea:

A – opacity

B – area of corneal opacity

 

Iris:

A – intensity of lesions

 

Conjuntivae:

A – erythema

B – chemosis

C – secreta

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information