Nitric acid, ammonium calcium salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 April - 2 May 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing: indivvidually in labeled Macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8-22.9
- Humidity (%): 31-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18 April 2007 To: 02 May 2007

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

selection based on trial formulations

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 square cm for males and 18 square cm for females
- % coverage: 10% of total body surface
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tap water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 ml/kg) body weigh
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for clinical signs, weekly determination of body weight
- Necropsy of survivors performed: yes (macroscopic examination only)
- Other examinations performed: none

Results and discussion

Preliminary study:

not performed

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: Males (recovery from these signs by day 3): lethargy, flat/hunched posture, uncoordinated movements, shallow respiration, piloerection, chromodacryorrhoea (snout), ptosis, hypothermia; Females (recovery from these signs by day 3): hunched posture, chromod

Gross pathology:

No abnormalities

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an acute dermal toxicity study in rats, Nitcal /K does not have to be classified and has no obligatory labelling requirement for dermal toxicity according to Regulation (EC) 1272/2008 and under GHS.