Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
other: JMAFF (2000) including recent revisions
GLP compliance:
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:
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
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.

Categories Display