Isobutyl (S)-2-chloropropionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-08-09 (day of application)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (non-GLP).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl (S)-2-chloropropionate

EC Number:

280-349-5

EC Name:

Isobutyl (S)-2-chloropropionate

Cas Number:

83261-15-8

Molecular formula:

C7H13ClO2

IUPAC Name:

isobutyl (S)-2-chloropropanoate

Details on test material:

- Name of test material (as cited in study report): L-chloropropionic acid isobutyl ester
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components:
- Lot/batch No.: no data
- Expiration date of the lot/batch: June 1985
No further data.

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
male/female Vienna white rabbits
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.43 kg (male), 2.44 kg (female), 2.41 kg (male) for animal no. 1, 2, 3, respectively
- Housing: single housing in steel cages with wire mesh bottom (ground area: 40 cm x 51 cm)
- Diet: Ovator Solikanin 4mm (Muskator Werke, Düsseldorf), ca. 130 mg/day
- Water: tap water, ca. 250 ml/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the test animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 ml
- Concentration (if solution): unchanged
A test patch (2.5 cm x 2.5 cm) was soaked with the undiluted test substance (0.5 ml).

VEHICLE: none

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3 (2 males and 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: occlusive
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scheme
readings at 30-60 minutes after removal of the test patches and at 24 h, 48 h, 72 h, and 8 d after beginning of application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1.56

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: desquamation at 8 days in 3/3 rabbits; see table for details

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

reading	animal no.	erythema	edema	symptoms
4 h	1	1	0	none
	2	1	0	none
	3	2	0	none
24 h	1	2	0	None
	2	1	2	none
	3	2	0	none
48 h	1	2	0	none
	2	1	0	none
	3	2	0	none
72 h	1	1	0	none
	2	1	0	none
	3	2	0	none
8 d	1	0	0	desquamation
	2	0	0	desquamation
	1	0	0	desquamation
mean 24 -72 h	1	1.67	0.00
mean 24 -72 h	2	1.00	0.67
mean 24 -72 h	3	2.00	0.00
mean 24 -72 h	all	1.56	0.22

Applicant's summary and conclusion

Interpretation of results:

Category III

Remarks:

Migrated information mild irritant Criteria used for interpretation of results: OECD GHS

Executive summary:

The undiluted test substance was applied to the intact skin of each of three rabbits for 4 hours under occlusive conditions. At the and of the application period, the skin was washed. The skin was examined at 30-60 minutes after removal of the test patches and at 24 h, 48 h, 72 h, and 8 d after beginning of application. The test substance was mildly irritating. Very slight to well-defined redness (Draizes scores 1 and 2, respectively) was noted in all rabbits at up to and including 72 hours. The skin was normal by day 8 with exception of desquamation observed in all rabbits at this time point.