Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Niacin bound chromatin (NBC), niacin-bound chromium complex comercially known as ChromeMate® CM-100M
- Substance type: powder
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: #306013

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Robinson Services Inc. (Clemmons, NC, USA)
- Diet (e.g. ad libitum): free access to lab chow (Purina Rabbit Chow No. 5326, St. Louis, Mo, USA)
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: 9 days prior to initiation of dosing


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24 °C
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: corn oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/pad of the 70% mixture
- Concentration (if solution): 70% w/w mixture of niacin-bound chromium III in corn oil
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after removal of test substance
Number of animals:
one male, two nulliparous and non-pregnant females
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100
- Type of wrap if used: 4-ply gauze pad; pad and entire trunk of animal secured with semi-occlusive 3 in. Micropore tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle cleaning of any residual test substance
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize Scoring System and calculation of Primary dermal irritation index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
1 male, 2 female
Score:
0.5
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
1 h after the application, very-slight erythema was observed at all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 48 h.
Other effects:
Apart from the dermal irritation noted, all animals appeared active and healthy and with no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Any other information on results incl. tables

Table: Primary dermal irritation scores in male and female New Zealand albino rabbitsaafter exposure to niacin-bound chromium

Time post installation (h)

Incidence of dermal irritation

Total PDIb

Primary Dermal Irritation Index (PDII)

erythema

edema

Individual

1

1.0

0.0

1.0

0.5

24

1.0

0.0

1.0

48

0.0

0.0

0.0

72

0.0

0.0

0.0

(a) Average values (n=3), (b) primary dermal irritation = average erythema + avergae edema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified