Niobium pentachloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Publication with a significant methodological deficiency. Only 1 mg of the test item was used. The guideline is recommending, that the dose should be 0.1 mL or 100 mg

Data source

Reference

Reference Type:

publication

Title:

Pharmacology and Toxicology of Niobium Chloride

Author:

Haley T.J., Komesu N., and Raymond K.

Year:

1962

Bibliographic source:

Toxicology and Applied Pharmacology 4: 385-392

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

1 mg of the test item was used. The guideline is recommending, that the dose should be 0.1 mL or 100 mg

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Niobium pentachloride

EC Number:

233-059-8

EC Name:

Niobium pentachloride

Cas Number:

10026-12-7

Molecular formula:

Cl5Nb

IUPAC Name:

Niobium(V) chloride

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Niobium pentachloride
- Analytical purity: 99.5%

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mg

Duration of treatment / exposure:

According to the method of Draize et al. (1944)

Observation period (in vivo):

According to the method of Draize et al. (1944)

Number of animals or in vitro replicates:

3

Details on study design:

According to the method of Draize et al. (1944). Three rabbits had 1 mg of niobium pentachloride placed in one eye while the
other eye served as a control.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

0

Remarks on result:

other: No evidence of corneal damage, iris damage, conjunctival irritation, chemosis or increased lachrymal fluid

Irritant / corrosive response data:

Direct application of 1 mg of niobium pentachloride to the eyes of rabbits resulted in an immediate increase in the rate of blinking and a redness of the palpebral conjunctiva within 1 hour. At 24 hours there was no evidence of corneal damage, iris damage, conjunctival irritation, chemosis, or increased lachrymal fluid.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item did not induce damages to the eye when an amount of 1 mg was applied to the rabbit eye. This amount is not sufficient to conclude on eye irritation properties according to CLP.

Executive summary:

In a primary eye irritation study according to the method of Draize et al. (1944), 1 mg of niobium pentachloride was placed into one eye of each of three rabbits. Animals then were observed for 24 hours. Only a very mild reaction immediately after application was observed, consisting of blinking and redness of the palpebral conjunctiva. After 24 hours no signs of any eye damage were observed. Under the conditions of the study and the dose applied (1 mg) niobium pentachloride can be considered as not eye irritating. This result has been disregarded as the small amount of the test item applied (1 mg) is not sufficient for CLP classification. According to OECD guideline 405 requirements, 100 mg of the test item needs to be applied. Thus, it can only be concluded that the puffer capacity of the lachrymal fluid is high enough to neutralize small amounts (1 mg) of the test item. Based on the study results it is not possible to derive a classification according to CLP. Due to the classification of NbCl5 as skin corrosive Cat 1B, severe eye damages would be expected if higher amounts of the test item would be applied to the eye.