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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

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:
C6H8O7.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