Pyrithione zinc

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pyrithione zinc

EC Number:

236-671-3

EC Name:

Pyrithione zinc

Cas Number:

13463-41-7

Molecular formula:

C10H8N2O2S2Zn

IUPAC Name:

Bis [1-hydroxy-2(1H)-pyridinethionato-O,S](T-4)-zinc

Details on test material:

Purity: 97.9%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: Charles River Germany
Sex: Female
Weight at study initiation: 1.7kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

84mg

Duration of treatment / exposure:

24h

Observation period (in vivo):

24h

Number of animals or in vitro replicates:

1

Details on study design:

Opthalmoscopic examinations: 60min and 24h

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24h

Reversibility:

not reversible

Remarks on result:

other: no ophthalmological examination possible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24h

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Severe and irreversible corneal lesions (corneal perforation suspected, leakage of aqueous humor), severe redness and swelling (score 3 and 4) were noted 24 h p.a. No observation of the iris was possible because of the severity of chemosis and of corneal alterations.
Due to the severity of lesions the animal was euthanised 24 h p.a. and no additional animals were administered.

Any other information on results incl. tables

Table 1.         Results of eye irritation study
	Cornea	Iris	Conjunctiva
			redness	chemosis
score (of one animal investigated)	0 to 4	0 to 2	0 to 3	0 to4
60 min	no ophthalmological examination possible	no ophthalmological examination possible	1	4
24 h	4	no ophthalmological examination possible	3	4
48 h	*	*	*	*
72 h	n.a.	n.a.	n.a.	n.a.
Average 24h, 48h, 72h	n.a.	n.a.	n.a.	n.a.
Area effected	gross destruction
Maximum average score (including area affected, max 110)	n.a.	n.a.	n.a.	n.a.
Reversibility^*	no	no	no	no
average time for reversion	n.a.	n.a.	n.a.	n.a.
Give method of calculation maximum average score. *             c :           completely reversible                n c :       not completely reversible                n :          not reversible	n.a.	n.a.	n.a.	n.a.

* The one animal was killed at 24 h for humane reasons.

 

Applicant's summary and conclusion

Interpretation of results:

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

Remarks:

Migrated information

Conclusions:

Zinc Pyrion technical powder Type A causes irreversible ocular lesions and poses a "risk of serious damage to eyes". This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.