Propanoic acid, 3-chloro-, 4-chlorobutyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2000-04-26 until 2000-08-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Good laboratory practice guideline study (OECD).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)

IUPAC Name:

3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)

Details on test material:

- Name of test material (as cited in study report): 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)
- Physical state: brown liquid
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 1/99
- Expiration date of the lot/batch: 2000-07-31
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Weight at study initiation: 2.5 - 2.9 kg
- Age: At least 6 weeks old
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 % rel. humidity
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated but shaved other side served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: patch held with an non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: 1-3

Time point:

other: 24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1-3

Time point:

other: 24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

>= 1.3 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

>= 0.7 - <= 1.7

Max. score:

1.7

Reversibility:

fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Substance is not irritating to the skin of rabbits

Executive summary:

The skin irritation study on three New Zealand White Rabbits according to OECD guideline 404 with 0.5 g of 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester) dosed semiocclusively did show only slight signs of irritating effects at the beginning of the observation period. The effects were revesible within 7 days. No other signs of toxicity were found.