Uronium hydrogen sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

end on 14-SEP-2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2010

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

This in vitro study was performed to assess the irritating or corrosive potential of the test item Aduct Urea-Sulfuric by means of the HET-CAM test. The test was carried out with fertilized and incubated chicken eggs. The aim was to evaluate the local irritating effects of Aduct Urea-Sulfuric on mucous membranes or eyes.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Uronium hydrogen sulphate

EC Number:

244-343-6

EC Name:

Uronium hydrogen sulphate

Cas Number:

21351-39-3

Molecular formula:

CH4N2O.H2O4S

IUPAC Name:

hydrogen [amino(hydroxy)methylidene]azanium sulfate

Details on test material:

- Name of test material (as cited in study report): Aduct Urea-Sulfuric
- Substance type: monoconstituent substance
- Stability under test conditions: not relevant
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

other: in-vitro test

Details on test animals or tissues and environmental conditions:

The HET-CAM test was carried out with Lohmann Selected Leghorn chicken eggs. The Lohmann Selected Leghorn chicken was selected for several reasons: the ability to hatch the eggs of this breed is very consistent and reproducible. There did not appear to be any hereditary defects in this breed.

Test system

Observation period (in vivo):

300 seconds

Number of animals or in vitro replicates:

three eggs

Details on study design:

In this HET-CAM assay the test item was tested pure. Three eggs were treated with the test item.
Each about 300 μL of the test item were applied directly to the membrane in order to cover at least 50% of the membrane. Each 300 μL of the positive and negative controls were applied to three eggs each. During the observation period for 300 seconds any lesions in close proximity to the covered membrane were monitored and recorded.
The membranes of the eggs were observed for 300 seconds. Lesions of the underlying blood vessels were monitored and noted. In particular three endpoints were observed and the time point at which an effect occurs was recorded. The three endpoints were:
• haemorrhage
• coagulation
• lysis of the blood vessel

Test Groups:
1. Negative Control: saline
2. Positive Control / Sodium dodecyl sulfate: 1% solution in deion. water
3. Positive Control / NaOH: 0.1 N
4. Test Item: pure

Evaluation of results:
CAM Mean Irritancy Index:
0 – 0.9: Not irritant
1 – 4.9: Slight irritant
5 – 8.9: Moderate irritant
9 - 21: Severe irritant

Results and discussion

In vivo

Irritant / corrosive response data:

Severe irritating effects were observed during 5 min incubation with Aduct Urea-Sulfuric. The calculated mean irritancy index is 10.27.
The positive controls induced a severe irritation on the blood vessels. The calculated mean irritancy indices are 9.95 for 1% SDS and 18.87 for 0.1 N NaOH.

Any other information on results incl. tables

Table 1: Results with Aduct Urea-Sulfuric, as well as negative and positive control

Test Group	Time until Haemorrhage [s]	Time until Lysis [s]	Time until Coagulation [s]	Irritancy Index	Mean Irritancy Index
Negative Control	301	301	301	0.00	0.00
Negative Control	301	301	301	0.00
Negative Control	301	301	301	0.00
Positive Control 0.1 N NaOH	9	61	24	18.78	18.87
Positive Control 0.1 N NaOH	9	50	19	19.18
Positive Control 0.1 N NaOH	10	66	24	18.64
Positive Control 1% SDS	18	76	301	9.97	9.95
Positive Control 1% SDS	17	80	301	9.89
Positive Control 1% SDS	23	71	301	10.00
Test Item	16	73	301	10.07	10.27
Test Item	12	60	301	10.44
Test Item	11	67	301	10.29

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It can be stated that in this study and under the experimental conditions reported, the test item Aduct Urea-Sulfuric (Uronium hydrogen sulphate) possess an irritating potential.

Executive summary:

This in vitro study was performed to assess the irritating potential of Aduct Urea-Sulfuric (uronium hydrogen sulphate) by detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs (HET-CAM, GLP).

The test item was tested pure.

The observation time was 5 minutes at room temperature.

Physiological sodium chloride solution (0.9% (w/v)) was used as negative control.

The negative control showed no irritating effect on the blood vessels under the membrane.

An 1% solution of SDS and 0.1 N NaOH were used as positive controls.

The positive controls (SDS and NaOH) induced severe irritation on the blood vessels.

Severe irritating effects were observed during 5 min incubation with Aduct Urea-Sulfuric. The calculated mean irritancy index is 10.27. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Aduct Urea-Sulfuric (uronium hydrogen sulphate) possess an irritating potential.