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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Endpoint summary

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Administrative data

Description of key information

No dermal reactions were observed at 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To determine the allergenic potential of the test chemical in guinea pigs
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
no data available
Route:
other: intracutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
First day 0.1 ml, then 0.2 ml on alternate days
Day(s)/duration:
10 days
Adequacy of induction:
not specified
No.:
#1
Route:
other: intracutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
5 male
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 10 days
- Test groups: 5
- Control group: no data available
- Site: no data
- Frequency of applications: First day 0.1 ml, then 0.2 ml on alternate days
- Duration: First day 0.1 ml, then 0.2 ml on alternate days
- Concentrations: First day 0.1 ml, then 0.2 ml on alternate days

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 2 weeks after last induction injection
- Exposure period: 24 hours
- Test groups: 5
- Control group: no data
- Site:
- Concentrations: 0.1 ml
- Evaluation (hr after challenge): 24 hours later
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.
Executive summary:

The allergenic potential of the test chemical was determined in guinea pigs. 5 male guinea pigs were injected intra cutaneously with a volume of 0.1 ml of the test chemical on day 1, then 9 volumes of 0.2 ml of the test chemical on alternate days.


2 weeks after last induction injection, the guinea pigs were challenged with 0.1 ml of the test chemical via intracutaneous injection. The sites were evaluated 24 hours later for signs of dermal sensitization.


No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on the available studies for the closely related chemicals, the weight of evidence approach was applied to assess the dermal sensitization potential of the nickel(II) EDTA complex.


Study 1 :


The allergenic potential of the test chemical was determined in guinea pigs. 5 male guinea pigs were injected intra-cutaneously with a volume of 0.1 ml of the test chemical on day 1, then 9 volumes of 0.2 ml of the test chemical on alternate days. 2 weeks after last induction injection, the guinea pigs were challenged with 0.1 ml of the test chemical via intracutaneous injection. The sites were evaluated 24 hours later for signs of dermal sensitization. No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.


Study 2 :


The study was conducted to determine the dermal sensitivity of test chemical. Male Hartley guinea pigs (10/group) were used for the study.Diglycidyl ether of 2,2-di(p,p’-hydroxyphenyl)propane was used as the positive control. The test chemical was applied topically as 10% solutions in Dipropylene glycol methyl ether and Polysorbate80(9:1). 0.1 ml of the test solutions were applied topically to the depilated, clipped backs of the guinea pigs, four times in 10 days. At the third application, 0.2 ml of Freund's adjuvant was injected intradermally adjacent to the application site. The guinea pigs were topically challenged on clipped flanks 2 weeks after the fourth treatment. The treatment sites were examined for irritation and sensitization at 24 and 48 hours after challenge exposure. Skin sensitization was observed in the group treated with the test chemical. Hence, the test chemical was considered to be not sensitizing to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results of the experimental studies from the closely related substances indicate that Nickel(II) EDTA complex is non sensitizer.


Hence by applying the weight of evidence approach using read across substance data, Nickel(II) EDTA complex can be considered to be not sensitizing to skin.