Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 July 2016 to 31 August 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized

EC Number:

270-180-5

EC Name:

Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized

Cas Number:

68412-26-0

Molecular formula:

C18H36N2Mo2O2S4X2 Where X = O or S

IUPAC Name:

Molybdenum oxide sulfide dibutyldithiocarbamate complex

Test material form:

solid: particulate/powder

Details on test material:

- Identification: Molybdenum, bis (dibutylcarbamodithioato)
- CAS Number: 68412-26-0

Specific details on test material used for the study:

CAS RN: 68412-26-0
Purity: This substance has an Unknown or Variable composition, is a Complex reaction product, or a Biological material (UVCB).
Physical state/Appearance: Yellow powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Hsdlf:NZW
- Age at study initiation: 12 to 52 weeks old
- Weight at study initiation: 3.23 or 3.24 kg
- Housing: Individually housed in suspended cages
- Diet: Certified Rabbit diet, ad libitum
- Water: Tap (drinking) water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): At least fifteen
- Photoperiod (hrs dark / hrs light): Controlled by a time switch to give 12 hours continuous light and 12 hours darkness

STUDY SCHEDULE
Experimental start date: 19 September 2016
Experimental completion date: 07 October 2016

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

72 hour

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (Draize, J.H, 1977).

Number of animals or in vitro replicates:

2

Details on study design:

Initially, a single rabbit was treated. A subcutaneous injection of a systemic analgesic was administered 60 minutes prior to test item application. Five minutes prior to test item application, a pre dose ocular anesthetic was applied to each eye.

The test item was placed into the conjunctival sac of the right eye. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made.

Eight hours after test item application, a subcutaneous injection of post dose analgesia was administered to provide a continued therapeutic level of systemic analgesia. The treated animal was checked for signs of pain and suffering approximately 12 hours later. No further analgesia was required.

After consideration of the ocular responses produced in the first treated animal, a second animal was similarly treated.

Examination of the eye was facilitated by the use of a standard ophthalmoscope. Any clinical signs of toxicity, if present, were also recorded. Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

fully reversible within: 72 hours

Any other information on results incl. tables

Ocular Reactions

No corneal effects were noted during the study.

Iridial inflammation (Grade 1) was noted in both treated eyes 1 hour after treatment only; as the eyes were clear of the test item, no irrigation of the eyes was necessary.

Moderate conjunctival irritation (Grade 2) was noted in both treated eyes 1 hour after treatment, with minimal conjunctival irritation noted at the 24 and 48-Hour observations.

Both treated eyes appeared normal at the 72-Hour observation.

 

Body Weight

No gain in bodyweight was noted in one animal, the other animal showed expected gain in body weight during the study.

 

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex	75570Male				75557Male
	IPR= 0				IPR = 0
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0
IRIS
D	1	0	0	0	1	0	0	0
Score (D x 5)	5	0	0	0	5	0	0	0
CONJUNCTIVAE
A = Redness	2	1	1	0	2	1	1	0
B = Chemosis	1	1	0	0	1	1	0	0
C = Discharge	1	0	0	0	1	0	0	0
Score (A + B + C) x 2	8	4	2	0	8	4	2	0
Total Score	13	4	2	0	13	4	2	0

IPR = Initial pain reaction

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals.

Executive summary:

The study was performed to assess the acute irritation/corrosion potential of the test item to the eye of the New Zealand White rabbit.  A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation.  Both treated eyes appeared normal at the 72 Hour observation.  The test item produced a maximum group mean score of 13.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.  The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals.