Hexachloroacetone

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye 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; ph value: 3.2

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source/Breeder: LPT Laboratory of Pharmacology and Toxicology KG; branch Löhndorf; D-24601Löhndorf/Post Wankendorf
- Age at study initiation: approx. 10 months
- Weight at study initiation: 2.6-2.9 kg
- Housing: For 8 hours following test substance application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 425 mm x 600 mm x 380 mm
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12/12, 150 lux

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL per eye in 3 animals

Duration of treatment / exposure:

1 test day

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE: no washing done
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

Any other information on results incl. tables

Under the present test conditions a single instillation of 0.1 mL Hexachloraceton per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:

Corneal opacity (grade 1) was observed in animal no. 3 at 24 hours after instillation.

The fluorescein test performed after 24 hours revealed corneal staining in animal no. 3 (1 /4 of the surface).

Conjunctival redness (grade 1) was noted in all animals from 1 hour up to 24 hours, in animal no. 3 up to 48 hours after instillation.

Conjunctival chemosis (grade 2) was observed in animal nos. one and two at 1 hour after instillation. Conjunctival chemosis (grade 1) was observed in animal no. two 24 hours after instillation, in animal no. three in 1 hour to 48 hours after instillation.

The iris was not affected by instillation of the test compound.

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 Jaws, 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 eyes, hence, no labelling is required.

Executive summary:

Test system: acute eye irritation study by instillation into the conjunctival sac of rabbits according to EC guideline B.5. and OECD guideline 405. Test substance: Hexachloraceton

Under the present test conditions a single instillation of 0.1 ml Hexachloraceton per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:

Corneal opacity(grade 1) was observed in animal no. 3 at 24 hours after instillation.

The fluorescein test performed after 24 hours revealed corneal staining in animal no. 3 (1/4 of the surface).

Conjunctival redness(grade 1) was noted in all animals from 1 hour up to 24 hours, in animal no. 3 up to 48 hours after instillation.

Conjunctival chemosis(grade 2) was observed in animal nos. one and two at 1 hour after instillation.Conjunctival chemosis(grade 1) was observed in animal no. two 24 hours after instillation, in animal no. three in 1 hour to 48 hours after instillation.

Theiriswas not affected by instillation of the test compound.

There were no systemic intolerance reactions.

According to the EC-Commission directive 67 /548/EEC and its subsequent amendments on the approximation of the Jaws, 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 eyes, hence, no labelling is required.