Hexachlorocyclopentadiene

Endpoint summary

Description of key information

A Harmonised Classification as Skin Corr. 1B; H314 is currently attributed to Hexachlorocyclopentadiene for skin irritation and corrosion. This Harmonised Classification was translated from Directive 67/548/EEC and should therefore be considered as a minimum classification unless there is evidence showing that the substance should be classified more severely.

The available data on the skin irritation and corrosion indicate that the substance is corrosive to the skin but do not provide evidence that Hexachlorocyclopentadiene should be classified more severely than the current Harmonised Classification.

 

An in vivo eye irritation study was performed according to a method similar to the OECD Testing Guideline 405 (non-GLP). The study was interrupted before the end of the observation period of 21 days due to the death of all animals, but it provides sufficient information to conclude regarding the potential of the substance to cause eye damage. The substance was found to be an extreme eye irritant and a possible corrosive substance (the irreversibility of the effects could not be assessed due to the death of the animals). Considering this result and the classification of the substance as Skin Corr. 1B; H314, it should be classified as Eye Dam 1; H318 according to Regulation (EC) N° 1272/2008. In addition, based on the mortality that occurred in this study, the sentence ‘EUH070 - Toxic through eye’ is applicable according to Regulation (EC) N° 1272/2008.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

other: expert assessment

Adequacy of study:

weight of evidence

Study period:

6 March 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was performed based on the Harmonised Classification and data on the in vivo skin corrosion of the substance.

Qualifier:

no guideline followed

Principles of method if other than guideline:

An assessment was performed based on the Harmonised Classification and data on the in vivo skin corrosion of the substance.

GLP compliance:

no

Remarks on result:

other: An assessment was performed based on the Harmonised Classification and data on the in vivo skin corrosion of the substance.

Irritant / corrosive response data:

Hexachlorocyclopentadiene is corrosive to the skin and should be classified as Skin Corr. 1B; H314.

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Hexachlorocyclopentadiene is corrosive to the skin and should be classified as Skin Corr. 1B; H314.

Executive summary:

A Harmonised Classification as Skin Corr. 1B; H314 is currently attributed to Hexachlorocyclopentadiene for skin irritation and corrosion. This Harmonised Classification was translated from Directive 67/548/EEC and should therefore be considered as a minimum classification unless there is evidence showing that the substance should be classified more severely.

The available data on the skin irritation and corrosion indicate that the substance is corrosive to the skin but does not provide evidence showing that Hexachlorocyclopentadiene should be classified more severely than the current Harmonised Classification. In conclusion, Hexachlorocyclopentadiene is corrosive to the skin and should be classified as Skin Corr. 1B; H314. It is not considered relevant to perform an additional study on the potential of the substance to induce skin corrosion.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Limited observation period due to the substance being toxic through the eye (all animals died as a result of the exposure to the substance).

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: ranging from 2032 to 2875 g
- Diet: ad libitum
- Water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye served as the untreated control for each rabbit

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Group I (5 animals) : 5 minutes
Group II (3 animals) : 24 hours

Observation period (in vivo):

21 days (interrupted after 9 days due to the death of all animals)

Number of animals or in vitro replicates:

8 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water for 2 minutes
- Time after start of exposure: 5 minutes (Group I) or 24 hours (Group II)

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

other: Observation of animals exposed to the substance for 5 minutes

Basis:

mean

Remarks on result:

other: Extreme irritant and probable corrosive substance

Irritation parameter:

other: Observation of animals exposed to the substance for 24 hours

Basis:

mean

Remarks on result:

other: Extreme irritant and probable corrosive substance

Irritant / corrosive response data:

Extreme irritant following a 5 minute or 24 hour exposure to the substance. The death of all animals prevented from assessing the reversibility of the effects after 21 days of observation but it was concluded by the authors of the study that the substance was probably corrosive.

Other effects:

All animals died by the 9th day of the observation period.

see attached background document

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The substance was found to be an extreme eye irritant and a probable corrosive substance (the irriversibility of the effects could not be assessed due to the death of the animals). Considering this result and the classification of the substance as Skin Corr. 1B; H314, it should be classified as Eye Dam 1. H318 according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

In addition, based on mortality which occurred in this study, the sentence ‘EUH070 - Toxic through eye’ is applicable according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Executive summary:

An in vivo eye irritation study was performed according to a method similar to the OECD Testing Guideline 405 (non-GLP) with deviations. The study was interrupted before the end of the observation period of 21 days due to the death of all the animals, but it is considered as providing sufficient information to conclude regarding the potential of the substance to cause eye damage.

Five New Zealand rabbits (Group I) and three New Zealand rabbits (Group II) received 0.1 ml of undiluted substance in the right eye and were exposed for 5 minutes or 24 hours respectively before removal of the substance by gentle washing. The effects to the eye in the animals were scored according to Draize.

The substance was found to be an extreme eye irritant and a probable corrosive substance (the irreversibility of the effects could not be assessed due to the death of the animals). Considering this result and the classification of the substance as Skin Corr. 1B; H314, it should be classified as Eye Dam 1. H318 according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

In addition, based on mortality which occurred in this study, the sentence ‘EUH070 - Toxic through eye’ is applicable according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Justification for classification or non-classification

The available data on the skin irritation and corrosion indicates that the substance is corrosive to the skin but does not provide evidence that Hexachlorocyclopentadiene should be classified more severely than the current Harmonised Classification as Skin Corr. 1B; H314.

 

The substance was found to be an extreme eye irritant and a possible corrosive substance. Considering this result and the classification of the substance as Skin Corr. 1B; H314, it should be classified as Eye Dam 1; H318 according to Regulation (EC) N° 1272/2008.

In addition, based on the mortality that occurred in this study, the sentence ‘EUH070 - Toxic through eye’ is applicable according to Regulation (EC) N° 1272/2008.