Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Endpoint summary

Description of key information

Skin Irritation/Corrosion : not irritating  ( OECD 404, GLP)
Eye irritation: not irritating (OECD 405, GLP)

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 and GLP compliant study

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/EEC, Method B4 OECD Guideline No. 404

GLP compliance:

yes

Species:

other: Rabbit, New Zealand white

Type of coverage:

semiocclusive

Vehicle:

other: Test substance was moistened with distilled water

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

erythema score

Score:

0

Remarks on result:

other: Max. duration; d; Max, value at end of observation period: 0 (related to all animals)

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

edema score

Score:

0

Remarks on result:

other: Max. duration; d; Max, value at end of observation period: 0 (related to all animals)

Other effects:

None of the animals showed any observable response to treatment throughout the four days observation period.

Interpretation of results:

other: not classified

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 and GLP compliant study

Qualifier:

according to guideline

Guideline:

other: Directive 94/449/EEC, Method B5 OECD Guideline No. 405

GLP compliance:

yes

Species:

other: Rabbit, New Zealand white

Amount / concentration applied:

65 mg

Number of animals or in vitro replicates:

3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Max. score:

1

Remarks on result:

other: Max. duration: 1h; Max. value at end of observation period: 0 (related to all animals)

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

chemosis score

Max. score:

0

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

cornea opacity score

Max. score:

0

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72h

Score:

0

Irritation parameter:

iris score

Max. score:

0

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 1 days

Other effects:

Very slight transient conjunctival reactions were observed at the one hour reading only.

Interpretation of results:

other: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

Two skin irritation/corrosion in vivo guideline studies carried out in the rabbit were available. A supporting study in 3 animals (occlusive) showed an erythema and odema score of 3 in 1 animal while 2 further animals showed no irritation for any parameter at any time point. The key study was carried out in accordance with OECD 404/GLP in 3 animals with 0.5 mg of substance applied for 4 hours using a semi-occlusive method and showed no irritation for any parameter in any animal at any time point. Based on this key study, the substance is not irritating to the skin.

Eye irritation

Two eye irritation in vivo guideline studies carried out in the rabbit were available. The first study (OECD 404, GLP) in 3 animals where the substance was applied as 65mg in a volume of 0.1mL showed no signs of any ocular lesions at any time point in any animals. The second study (OECD 404, GLP) in 3 animals where the substance was applied as 65 mg showed conjunctival redness (mean score of 1) across all animals which was fully reversible within 1 day. The second study was chosen as the key study as there was a very mild transient effect and the conclusion was the substance was not irritating to the eyes.

Justification for selection of skin irritation / corrosion endpoint:
OECD Guideline and GLP compliant study

Justification for selection of eye irritation endpoint:
OECD Guideline and GLP compliant study

Justification for classification or non-classification

Based on the available information in the dossier, the substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) does not need to be classified for skin irritation/corrosion or eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.