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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 15 January 2013 to 25 January 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study performed according to OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Barium nitrate
- Substance type: Inorganic
- Physical state: White crystals
- Analytical purity: 99.52%
- Lot/batch No.: 120724
- Expiration date of the lot/batch: 07 September 2013 (allocated by WIL Research Europe B.V., 1 year after receipt of the test substance)
- Stable under storage conditions
- Storage condition of test material: At room temperature in the dark
- Other:
pH: 5.0-8.0
Stability at higher temperatures: yes, maximum 70°C for maximum 30 minutes
Stability in vehicle: water: not indicated
Solubility in vehicle: water: 10.5 g/100 mL (25°C)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kissleg, Germany
- Age at study initiation: Animals used within the study were at least 8 weeks old
- Weight at study initiation: at least 1 kg
- Housing: Animals were individually housed in labeled cages with perforated floors (dimensions 67 x 62 x 55 cm) and shelters (dimensions 40 x 32 x 23 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24 °C
- Humidity (%): 40 to 70%
- Air changes (per hr): 15 room air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
the substance was moistened with 0.1mL of water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams

VEHICLE
The test substance was moistened with 0.1 mL of the vehicle
Duration of treatment / exposure:
4 hours
Observation period:
Mortality/viability: twice daily
Toxicity: at least once daily
Body weight: day of treatment (prior to application) and after the final observation
Necropsy: No necropsy was performed according to protocol
Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
No histopathology was performed.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
- Type of wrap if used: The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.

SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded.
Erythema and eschar formation: scores from 0 to 4
Oedema formation: scores from 0 to 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:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Irritation: No skin irritation was caused by 4 hours exposure to barium nitrate.
Corrosion: There was no evidence of a corrosive effect on the skin.
Coloration/remnants: No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
Other effects:
Toxicity/mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results barium nitrate does not have to be classified and no obligatory labelling requirement for skin irritation according to Globally Harmonized System of classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.