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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under RegulationEC 1907/2006.

Skin Irritation

In a GLP compliant acute dermal irritation / corrosion test in rabbits according to OECD 404 conducted byWolf (2001), no irritation was observed.

 In a further GLP compliant study byCerven (1991), which complies with OECD 404, some slight Oedema was noted.

Accordingly, zinc pyrithione does not meet the criteria for classification as irritating to skin and is thus classified as non-irritating to skin for both DSD and CLP.

Table 5.4: Summary of skin irritation

Method

Results

Remarks

Reference

OECD 404.

GLP (self certification by the laboratory)

Skin, Rabbit, New Zealand Albino, 6 males.

Erythema – 0.0

Oedema – 0.0

Reversibility – Yes

Not irritating to skin

Reliability – 1

Purpose flag

Study result type

The test material was Zinc Pyrion powder (97.9%)

Key study

Wolf T (2001)

(unpublished)

US EPA 81-5, which complies with OECD 404.

GLP (self certification by the laboratory)

Skin, Rabbit, New Zealand Albino, 6 males

Erythema – 0.0

Oedema – 0.11

Reversibility – Yes

Mildly irritating(below classification level)

Reliability – 1

Purpose flag

Study report type

The test material was 0.5g water moistened Zinc Omadine powder (>97%)

Cerven DR (1991)

(unpublished)

.

Eye Irritation

In a GLP study to OECD 405,Wolf (2002)identified severe and irreversible corneal lesions at 24 hours.

In a further GLP study conducted to US EPA 81-5 which complies with OECD 405, Cerven (1991) also noted severe corneal damage which persisted to day 7 (at which time animals were euthanised).

The above data indicates that zinc pyrithione meets the criteria for classification as:-

DSD:  Irritant, R41, Risk of serious damage to eyes.

CLP:   Eye Dam cat 1, H318, Causes serious eye damage.


Table 5.5: Summary of eye irritation

Method

Results

Remarks

Reference

US EPA 81-5, which complies with OECD 404.

GLP (self certification by the laboratory)

Eye, Rabbit, New Zealand Albino, 8 females and 1 male.

 

Cornea

Unwashed eye: 3.1

Washed eye: 3.6

Iris

Unwashed eye: 1.2

Washed eye: 1.0

Conjunctiva

Redness

Unwashed eye: 3.0

Washed eye: 3.0

Chemosis

Unwashed eye: 4.0

Washed eye: 3.4

Reversibility

Unwashed eye: Due to persistence and severity of irritation, animals were euthanized on day 7.

Washed eye: Similar responses were noted, only one eye cleared by day 21, while the response in the other animals persisted.

 

Reliability – 1

Purpose flag

Study result type

The test material was 0.1 ml Zinc pyrithione powder (>97%).

Cerven DR (1991)

(unpublished)

OECD 405.

GLP (self certification by the laboratory)

Eye, Rabbit, New Zealand Albino, 1 female.

 

Cornea– 4 (at 24 hr)

Iris– No ophthalmological examination was possible

Conjunctiva

Redness– 3 (at 24 hr)

Chemosis– 4 (at 24 hr)

Reversibility

Severe and irreversible corneal lesions (corneal perforation suspected) severe redness and swelling were noted 24 hr p.a.

Due to the severity of lesions the animal was euthanized 24 hr p.a.

 

Reliability – 1

Purpose flag

Study result type

The test material was 0.1 ml Zinc Pyrithione powder (97.9%)

Key study

Wolf T (2001)

(unpublished)



Effects on eye irritation: corrosive

Justification for classification or non-classification