Hexachloroacetone

Endpoint summary

Description of key information

Hexachloroacetone doesn`t require labelling for either skin or eye irritation:
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.
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 
conditions Hexachloraceton was non irritating to eyes, hence, no labelling is required.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 9 days

Score:

0

Irritation parameter:

other: eschar/oedema formations

Basis:

mean

Time point:

other: 9 days

Score:

0

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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.

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.

Justification for selection of skin irritation / corrosion endpoint:
OECD 404 guideline study

Justification for selection of eye irritation endpoint:
OECD 405 guideline study