Nitric acid, ammonium calcium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January, 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study has been performed according to OECD and/or EC guidelines and according to GLP principles. However, since the study was performed with a substance analogue and the data are read across, the Klimisch score is 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF (2000) including recent revisions

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium

EC Number:

231-119-8

EC Name:

Potassium

Cas Number:

7440-09-7

Molecular formula:

K

IUPAC Name:

potassium

Constituent 2

Reference substance name:

Calcium

EC Number:

231-179-5

EC Name:

Calcium

Cas Number:

7440-70-2

Molecular formula:

Ca

IUPAC Name:

calcium

Constituent 3

Reference substance name:

Ammonium nitrogen

IUPAC Name:

Ammonium nitrogen

Constituent 4

Reference substance name:

Nitrate nitrogen

IUPAC Name:

Nitrate nitrogen

Test material form:

solid: granular

Details on test material:

- Name of test material (as cited in study report): Nitcal/K
- Physical appearance: White granules
- Storage conditions: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 31-58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09 January 2007 To: 26 January 2007

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 grams
The test material was moistened with 0.4 ml of water

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours after removal of dressings

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 150 square cm
- % coverage: not indicated
- Type of wrap if used: metalline patch applied to the skin of one flank wrapped around the abdomen and secured with elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: numerical scoring system for erythema and eschar formation (0-4) and for oedema formation (0-4)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No skin irritation was seen.

Other effects:

No symptoms of systemic toxicity, no mortality was seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of a skin irritation study in rabbits, Nitcal/K does not have to be classified or labelled for skin irritation according to Regulation (EC) 1272/2008 and under GHS.