Sodium 2,4-dichlorophenoxyacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Sep. 1991 - 22 Sep. 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: Experiment was conducted under occlusive conditions

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2,4-dichlorophenoxyacetate

EC Number:

220-290-4

EC Name:

Sodium 2,4-dichlorophenoxyacetate

Cas Number:

2702-72-9

Molecular formula:

C8H6Cl2O3.Na

IUPAC Name:

sodium 2-(2,4-dichlorophenoxy)acetate

Details on test material:

- Name of test material (as cited in study report): Pielik 85 SP or 2,4-D sodium salt
- Physical state: white powder with an intense, characteristic smell
- Analytical purity: 94%
- Impurities (identity and concentrations): Chlorphenols expressed as 2,4-D Chlorphenol (0.3%); Substances insoluble in water (0.01%)
- Purity test date: 11th July 1991 (Certificate No. 1046/PK 91)
- Melting temperature of the 2,4-D acid: 139°C

Test animals

Species:

rabbit

Strain:

other: New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
females
- Source: Rabbits Breeding S-52, Zator
- Age at study initiation: 3 - 6 months
- Weight at study initiation: 3,5 kg (mean)
- Housing: individually in cages (80 x 80 x 60 cm)
- Diet: granulated standard food and hay (Toxic impurities were below the limits of the FDA), both ad libitum
- Water: :ad libitum (drinking water quality)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 4°C

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4h

Observation period:

1h, 24h, 48h and 72h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: clipped dorsal trumk of the animals
- Type of wrap if used: gauze patch holding in place with non-irritating tape; fixation with an occlusive dressing

SCORING SYSTEM:
According to the OECD guideline No.404 (Table: grading of skin reactions)
TEST SITE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of animals #1, 2 and 3

Time point:

other: average 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: No effects observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of animals # 1, 2 and 3

Time point:

other: average 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: No effects observed

Irritant / corrosive response data:

After patch removal there were no signs of erythema and edema at all time-points

Any other information on results incl. tables

Table 1: Pielik 85 SP – Evaluation of the skin reaction

Skin reaction	Rabbit No.	Irritation scores after
		24 h	48 h	72 h
Erythema	1 2 3	0 0 0	0 0 0	0 0 0
Edema	1 2 3	0 0 0	0 0 0	0 0 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information