3-chloropropene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1990-10-22 to 1990-11-13

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: - scientifically sound study - limited reporting, non-GLP - no substance purity information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only two animals tested

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-chloropropene

EC Number:

203-457-6

EC Name:

3-chloropropene

Cas Number:

107-05-1

Molecular formula:

C3H5Cl

IUPAC Name:

3-chloroprop-1-ene

Details on test material:

- Name of test material (as cited in study report): Allylchlorid, BAS 480 F
- Physical state: not reported
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Purity test date: not reported
- Lot/batch No.: 23469-77BD
- Expiration date of the lot/batch:
- Stability under test conditions: not reported, but expected to be stable

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: no data, presumably shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 100 %

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: not reported
- Type of wrap if used: semi occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with Lutrol and Lutrol 50 % (Lutrol = PEG 400)
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize score system

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: average of scores at 24, 48 and 72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: see table 1 for individual animal information

Irritant / corrosive response data:

a mild redening was seen in both animals after 1 and 24 h which was fully reversible within 48 h in both.

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

3-Chloropropene was tested for its potency to cause skin irritation in an in vivo test in rabbits according to OECD 404 using 0.5 g of substance. The only effect noted was a slight reddening of the treated skin that persisted for 24 h and was fully reversible within 48 h. No edema were reported. Based on this results the test item is not irritating in this test system and a classification according to CLP is not necessary

Executive summary:

In the present study (BASF 1990) 3-Chloropropene was tested for its potency to cause skin irritation in an in vivo test in rabbits according to OECD 404 using 0.5 g of substance. The only effect noted was a slight reddening of the treated skin that persisted for 24 h and was fully reversible within 48 h. No edema were reported. Based on this results the test item is not irritating in this test system and a classification for skin irritation according to CLP as implementation of UN GHS in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) is not necessary.

Animals were treated with 0.5 g of the undiluted test item on shaved skin followed by a incubation for 4 h under semiocclusive conditions. Subsequentially the solution was washed of with once 100 % Lutrol (= PEG 400) and once 50 % Lutrol in water. The formation of erythema and edema was scored at 60 min, 24, 48 and 72 h after the start of the incubation. As the initially developed slight reddening in both animals (erythema score 1, edema score 0) was fully reversible within 48 h the test was stopped 72 h after the start of treatment. Only two animals were treated, but as the effect is minimal and the results unequivocal, the test is judged to be reliable except for the uncertainty on substance purity.