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Diss Factsheets

Administrative data

Description of key information

Read across nickel diacetate (CAS 373-02-4): not irritating to skin


Read across nickel diacetate CAS 373-02-4): not irritating to the eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For justification of read across please refer to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Reported as nickel acetate, Lot #: PTL N103
Test material form: paste (semi-solid, amorphous; gel)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Female young adult non-pregnant and nullliparous animals were received from Robinson Services Inc. Animals were housed individually in suspended stainless steel cages with mesh floors and enrichment (e.g. toys) placed in each cage).
Room temperature: 12-21 degrees C
Humidity: 30-33%
Air changes: 13/hour
Photoperiod: 12-hour light/dark cycle
Acclimation period: 12 days
Food: Harlan Teklad Global High Fiber Rabbit Diet #2031
Water: Filtered tap water
Contaminants: none known, tested regularly
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g of test substance on 1 inch x 1 inch square gauze pad applid to 6 cm2 area of skin on each animal.
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, and 24, 48, and 72 hours
Number of animals:
3
Details on study design:
Test animals were exposed to nickel acetate as a dry paste for 4 hours followed by obervations of up to 72 hours to detect irritation.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None of the 3 animals tested demonstrated irritation from the application at any observation time.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not irritating to skin in this in vivo study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For justification of read across, please refer to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Vehicle:
unchanged (no vehicle)
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1998 to November 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA.
- Age at study initiation: Adult
- Weight at study initiation: not reported
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 19-50%
- Air changes (per hr): 10-15 per hour
- Photoperiod: 12-h light/12-h dark photoperiod.

IN-LIFE DATES: not reported
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
single application, washing of eye after 24 hours
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
3
Details on study design:
Both eyes of each test animal were examined prior to testing to identify any pre-existing ocular irritation or corneal injury. Three rabbits (one male and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed. The test article was instilled into the conjunctival sac of the right eye of each animal, a minimum of 1 hour after preliminary examination. Following instillation, the eyelids were gently held together for one second to limit test article loss. The untreated left eye of each animal served as the control. Animals were examined twice daily. Body weights were measured prior to dosing. All animals were sacrificed at the end of the study duration. No necropsy examinations were performed.

REMOVAL OF TEST SUBSTANCE
- Washing: using physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: Ocular observations were conducted at 1, 24, 48 and 72 hours and up to 7 days after dosing. Eyes were scored using the EEC Ocular Evaluation Criteria, which is based on Draize (1959).

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Exposure to the test article produced irrititis in 3/3 test eyes at the 1-hour scoring interval.
The irititis resolved completely by 48 hours. Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval.
Conjunctival irritation resolved completely in all test eyes by study day 7.
Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not considered to be clssified for eye irritation based on this in vivo study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

No data on the skin and eye irritation potential of the target substance itself is available. Therefore, read across to nickel diacetate (CAS 373-02-4) was applied.


The data was obtained from the ECHA disseminated Dossier of the substance.


To assess the potential of nickel diacetate to induce skin irritation, an in vivo study according to OECD Guideline No. 404 was conducted. Three female young adult non-pregnant and nulliparous rabbits were used as test animals. The test substance (paste) was applied to the clipped test site on the animals and covered semiocclusively for 4 hours. Observations were made 30-60 minutes, and 24, 48, and 72 hours after treatment. No signs of irritation (edema, erythema) were noted. Therefore the test substance was considered to be non-irritating to skin.


To assess the potential of nickel diacetate to cause eye irritation an in vivo study according to OECD Guideline No. 405 using rabbits was conducted. Three rabbits (one male and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed. The test article was instilled into the conjunctival sac of the right eye of each animal. The untreated left eye of each animal served as the control. Animals were examined twice daily. Exposure to the test article produced iritis in 3/3 test eyes at the 1-hour scoring interval. The iritis resolved completely by 48 hours. Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval. Conjunctival irritation resolved completely in all test eyes by study day 7. The 24/48/72 hours mean scores for animal 1, 2 and 3 were 0.33, 0.33, 0.66 for chemosis, 0.33, 0.33, 1.33 for conjunctival redness, 0.33, 0.33, 0.33 for iridial redness and 0, 0, 0 for cornea opacity, respectively.


Based on the results of the test, the test substance is not considered to be classified for eye irritation.


 


 


 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008


The available data on skin and eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.