Nickel(2+) hydrogen citrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

28 Apr - 29 Jun 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ICCVAM recommended HET-CAM test method protocol (Nov. 2006)

Deviations:

no

Principles of method if other than guideline:

The in vitro study was performed to evaluate the irritating potential of nickel hydrogencitrate by detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs.

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Nickel(2+) hydrogen citrate

EC Number:

242-533-3

EC Name:

Nickel(2+) hydrogen citrate

Cas Number:

18721-51-2

Molecular formula:

C6H6O7.Ni (C6H8O7.Ni, as specified in the EC inventory, correspond to citric acid.Ni)

IUPAC Name:

hydrogen nickel(2+) citrate

Details on test material:

- Name of test material (as cited in study report): Nickel Hydrogencitrat
- Analytical purity: > 99%
-Batch No.: WRG 09012701037
- Storage condition of test material: 20 ± 5°C, dry
- Date of production: 27 Jan 2009
- Date of expiry: 26 Jan 2011

Test animals / tissue source

Species:

other: Lohmann selected Leghorn chicken´s egg

Strain:

other: Lohmann selected Leghorn chicken´s egg

Details on test animals or tissues and environmental conditions:

The eggs were obtained from the LSL Rhein Main Geflügelvermehrungsbetrieb, Dieburg, Germany.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 µL (mean weight: 0.1847 g)

Duration of treatment / exposure:

not applicable; see "any other information on materials and methods"

Observation period (in vivo):

not applicable; see "any other information on materials and methods"

Number of animals or in vitro replicates:

not applicable; see "any other information on materials and methods"

Results and discussion

Any other information on results incl. tables

Experimental observations and irritation scores are given in table 1 and table 2, respectively.

The negative control showed no irritating effects on the blood vessels. The calculated mean irriation score was 0.0.

Solutions of SDS (1%) and NaOH (0.1 N) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The calculated mean irriation score were 10.48 for SDS and 19.56 for NaOH.

The test item Nickel Hydrogencitrat showed effects on the blood vessels of the CAM. The calculated mean irriation score was 5.85.

Under the experimental conditions, the test item is moderately irritating to the eyes.

Table 1: experimental observations      

Test Group	Time until Haemorrhage	Time until Lysis	Time until Coagulation
	seconds	seconds	seconds
Negative Control	301	301	301
Negative Control	301	301	301
Negative Control	301	301	301
Positive Control 0.1 NaOH	9	31	22
Positive Control 0.1 NaOH	8	33	19
Positive Control 0.1 NaOH	8	34	20
Positive Control 1% SDS	14	54	301
Positive Control 1% SDS	12	58	301
Positive Control 1% SDS	15	59	301
Nickel Hydrogencitrat	150	175	301
Nickel Hydrogencitrat	104	168	301
Nickel Hydrogencitrat	135	179	301
Nickel Hydrogencitrat	139	171	301
Nickel Hydrogencitrat	114	1701	301
Nickel Hydrogencitrat	123	183	301

Calculation of the irritation score

The irritation score was calculated from the following equation:

IS= ((301 -time until haemorrhage)/300)*5 + ((301 -time until lysis)/300)*7 + ((301 -time until coagulation)/300)*9

The calculated IS for each replicate and the corresponding means are presented in the following table:

Table 2: irritation score  

Test Group	Irritation Score	Mean Irritation Score
Negative Control	0.00	0.00
Negative Control	0.00
Negative Control	0.00
Positive Control 0.1 NaOH	19.54	19.56
Positive Control 0.1 NaOH	19.60
Positive Control 0.1 NaOH	19.54
Positive Control 1% SDS	10.55	10.48
Positive Control 1% SDS	10.49
Positive Control 1% SDS	10.41
Nickel Hydrogencitrat	5.46	5.85
Nickel Hydrogencitrat	6.39
Nickel Hydrogencitrat	5.61
Nickel Hydrogencitrat	5.73
Nickel Hydrogencitrat	6.17
Nickel Hydrogencitrat	5.72

Classification of the irritation potential is made as stated in the table 3:

Irritation Score (IS)	Classification
0 - 0.9	not irritant
1 - 4.9	slightly irritant
5 - 8.9	moderately irritant
9 - 21	severely irritant

The validity criteria and findings are given in the table 4:

Parameter	Criterion	Found	Assessment
IS of negative controls	< 0.9	0.0	ok
IS of positive controls	> 9	19.56 (NaOH) 10.48 (SDS)	ok

 

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information