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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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: Guideline study with limited documentation
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Remarks:
reporting in publication not as detailed as in a guideline study report
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 / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues 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: 7 days prior to initiation of dosing


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
water
Controls:
other: left eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.05 g) of NBC in water
Duration of treatment / exposure:
Application into the conjuntival sac lasted for appr. 1 sec. The test substance remained in the eye.
Observation period (in vivo):
1, 24, 48, and 72 h post-installation
Number of animals or in vitro replicates:
two males, one nulliparous and non-pregnant female
Details on study design:
SCORING SYSTEM: primary eye irritation score according to system by Kay and Calandra 1962; eye lesions were scored were scored according to Draize scale


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Irritation parameter:
other: conjunctivitis incidence
Basis:
other: per three animals
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
No corneal opacity or iritis was observed in any treated eye during the study. One hour following test substance instillation, all treated eyes exhibited conjunctivitis. All animals were free of ocular irritation within 24 h.
Other effects:
Apart from the eye irritation noted, all animals appeared active and healthy. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Any other information on results incl. tables

Under the conditions of this study niacin-bound chromium is practically non-irritating to the eye.

Table: Incidence, severity and reversibility of ocular irritation in New Zealand albino rabbits after exposure to niacin-boun chromium (n=3)

Time post installation (h)

Incidence of ocular irritation

Severity of irritation

Corneal opacity

Iritis

Conjunctivitis

MMT(a) score

1

0/3

0/3

3/3

2.0

24

0/0

0/0

0/0

0.0

48

0/0

0/0

0/0

0.0

72

0/0

0/0

0/0

0.0

(a) MMT = maximum mean total

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