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Toxicological information

Acute Toxicity: dermal

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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 was performed with a substance analogue and the data are read across.

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

Constituent 1
Chemical structure
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
Chemical structure
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:
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, chromodacryorrhea.
Treated skin showed signs of irritation (scales, scabs, maculate erythema) during observation period
Body weight:
The mean body weight gain during the observation period was within the expected range
Gross pathology:
No abnormalities

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified according to Regulation (EC) 1272/2008
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 the CLP Regulation.