Zinc dilactate

Endpoint summary

Description of key information

Zinc lactate is very irritating to the eye, but not irritating to the skin.

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

Study period:

2013-03-20 to 2013-05-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

EXPERIMENTAL ANIMALS:
- Species: New Zealand White rabbits
- Source: S&K-LAP Kft, 2173 Kartal, Császár út 135, HUNGARY
- Age of animals at treatment: ~12 weeks old
- Sex: Male
- Body weight range at the beginning of the in-life phase: 3211–3394 g, at the end of the in-life phase: 3278–3491 g

HUSBANDRY:
- Lightning periods: 12 hours daily
- Temperature during the study: 17.1 19.5 °C
- Relative humidity during the study: 24–56%
- Air changes: 15-20/h
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.

FOOD and FEEDING:
- Animals received UNI diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary, ad libitum.

WATER SUPPLY:
- Animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Animals were their own control

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

Observation at 1, 24, 48, 72 hours after exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage: full
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not Relevant

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None

Other effects:

None

At observation one hour after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 24 hours after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 48 and 72 hours after patch removal, no clinical signs were noted on the skin of the treated animals. As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.00 respectively. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively. The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute skin irritation study (OECD 404) Puramex Zn was not irritating to the skin of New Zealand White rabbits.

Executive summary:

An acute skin irritation study was performed with Puramex Zn in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No. 404, 2002). An amount of 0.5 g of the test item was applied to the skin of the test animals. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin. Sterile gauze pads were placed on the skin of rabbits. These gauze pads were kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control. After 4 hours, the remaining test item was removed with water at body temperature. To assess skin irritation, animals were examined at 1, 24, 48, and 72 hours after the patch removal. Additional general examinations were performed daily. There was no mortality during the observation period. There was no test item related effect on body weight. At observation one hour after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 24 hours after patch removal, no clinical signs were noted on the skin of the treated animals. At observation 48 and 72 hours after patch removal, no clinical signs were noted on the skin of the treated animals. As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.00 respectively. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively. The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.

According to Directive 2001/59/EC, Puramex Zn does not require classification as a skin irritant. According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Puramex Zn does not require classification as a skin irritant. According to the classification system based on the scheme devised by Draize (1959), Puramex Zn is a "non-irritant".

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

Study period:

1995-01-25 to 1995-02-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

equivalent or similar to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

other: Methodology indicated in the Official French Gazette of 09 June 1992

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: CARON - Saint Germain Laxis 77590 MAINCY
- Weight at study initiation: about 2.5 to 3 kg at the time of the trial
- Housing: The animals are kept in individual polystyrene cages of standardized dimensions with perforated floor.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22
- Humidity (%): 50-80
- Air changes (per hr): filtered and recyled air is renewed at the the rate of 3000 m³/h
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye used as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

0.1 g of the test item is instilled in the lower right fornix of conjunctiva in each animal. The eyelids of the animals are kept shut for about 10 seconds in order to avoid product loss. The eyes are not rinsed.

Observation period (in vivo):

1, 24, 48 and 72 hours until day 7.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.66

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4 d

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.66

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 4 d

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

2

Reversibility:

fully reversible within: 4 d

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Irritant / corrosive response data:

The observed lesions are severe. The corneal injuries are serious, involving the whole cornea, slightly reversible until D7 but still remaining for 2 animals over 1/2 cornea. The iris congestion is severe; the photomotor reflex is slowed down; the reversibility is total at D7 for only one animal. The conjunctival injuries are important, slowly reversible over 7 days, the reversibility is not total at D7.

Interpretation of results:

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

Conclusions:

In conclusion, zinc lactate is very irritating to the eye.

Executive summary:

In a primary eye irritation study (equivalent to OECD 405), 0.1 g of the test item was instilled into the lower right fornix of the conjunctiva of three New Zealand White rabbits. The animals were observed for 7 days. Irritation was scored by the method according to OECD guideline 405. Based on the results, it can be considered that the test item is very irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Zinc lactate was tested negative for dermal irritating properties in accordance with OECD test guideline 404. In the key study for eye irritation, zinc lactate induced severe eye irritation.

Justification for classification or non-classification

Zinc lactate did not cause any skin effects in an acute dermal irritating study in accordance to OECD test guideline 404. Therefore, the substance does not warrant classification for skin irritation. Based on the available data zinc lactate can be considered as severely irritating to the eye hence warrants classifcation as eye irritant (Category 1, H318).