Hexachloroacetone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hexachloroacetone

EC Number:

204-129-5

EC Name:

Hexachloroacetone

Cas Number:

116-16-5

Molecular formula:

C3Cl6O

IUPAC Name:

hexachloropropan-2-one

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Hexachloraceton
- Physical state: colourless liquid
- Analytical purity: 99.52%
- Lot/batch No.: 1HC109004
- Expiration date of the lot/batch: 2002-12-31
- Stability under storage conditions: at + 25°C: < 1 year
- Storage condition of test material: at room temperature, dark, tightly closed
- Other: density 1.7431 g/cm³ (at room temperature); pH value 3.2 (20°C; 7.8 g/L H2O)

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG; branch Löhndorf; D-24601 Löhndorf/Post Wankendorf
- Age at study initiation: approx. 11 months
- Weight at study initiation: 2.3-2.7 kg
- Housing: Before and after the 4-hour exposure period, the animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm.
During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine.
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL (approx. 6 cm²)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- coverage: approx. 6 cm²
- Type of wrap if used: patch

REMOVAL OF TEST SUBSTANCE
- no residual test substance had to be removed

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 9 days

Score:

0

Results 2

Irritation parameter:

other: eschar/oedema formations

Basis:

mean

Time point:

other: 9 days

Score:

0

Any other information on results incl. tables

Under the present test conditions three rabbits were exposed for 4 hours to 0.5 ml Hexachloraceton/ patch and animal (semi-occlusive condition). An erythema (grade1) was noted in animal no. 1 from 24 hours up to 7 days and in animal nos. 2 and 3 from 24 hours up to 8 days after patch removal. An oedema (grade 1) was noted in animal no. one at 60 min, in animal no. two from 60 min up to 24 hours, and in animal no. three from 60 min up to 48 hours after patch removal. There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the EC-Commission directive 67 /548/EEC and its subsequent amendments on the approximation of the laws, regulations and
administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present
test conditionsHexachloraceton wasnon irritating to skin, hence, no labelling is required.

Executive summary:

Test system: acute skin irritation test (patch test) in rabbits according to EC guideline 8.4. and OECD guideline 404

Test substance: Hexachloraceton. Under the present test conditions three rabbits were exposed for 4 hours to 0.5 mL Hexachloraceton/ patch and animal (semi-occlusive condition). An erythema (grade 1) was noted in animal no. 1 from 24 hours up to 7 days and in animal nos. 2 and 3 from 24 hours up to 8 days after patch removal. An oedema (grade 1) was noted in animal no. one at 60 min, in animal no. two from 60 min up to 24 hours, and in animal no. three from 60 min up to 48 hours after patch removal.

There were no systemic intolerance reactions.

According to the EC-Commission directive 67 /548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditionsHexachloraceton wasnon irritating to skin, hence, no labelling is required.