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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013-01-14 to 2013-02-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2012-11-30

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexanoic acid, molybdenum salt
EC Number:
251-807-1
EC Name:
2-ethylhexanoic acid, molybdenum salt
Cas Number:
34041-09-3
Molecular formula:
C8H16O2.xMo
IUPAC Name:
2-ethylhexanoic acid, molybdenum salt
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS - New Zealand White (Hsdlf:NZW) strain rabbits
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.66 or 2.68 kg
- Housing: the animals were individually housed in suspended cages.
- Diet (ad libitum): 2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Relative humidity: 30 to 70%
- Air exchange: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. 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.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
Approximately 1 hour and 24, 48 and 72 hours as well as Days 7 and 14 following treatment
Number of animals or in vitro replicates:
2 male rabbits
Details on study design:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.

INITIAL AND CONFIRMATORY TEST
Initially, a single rabbit was treated. Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the six point scale (please refer to table 2 in the field "Any other information on materials and methods incl. tables" below).
After consideration of the ocular responses produced in the first treated animal, a second animal was treated.

SCORING SYSTEM: according to the Draize scale
Any other ocular effects were also noted.
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.

TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Initial pain reaction: practically no initial pain was observed. Area of cornea involved (opacity): one quarter (or less) but not zero (observed from 1 hour to 72 hours).
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Slight inflammation of iris was observed at the 1 hour observation.
Remarks on result:
other: Severe to slight discharge was observed from the 1 hour observation to the 48 hours observation. Reddish brown coloured staining of the fur around treated eye was observed at the 1, 24, 48, and 72 hours as well as on day 7 observation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Moderate conjunctivae redness was observed at the 1 hour observation. Slight conjunctivae redness was observed on Day 7.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Moderate chemosis was observed at the 1 hour observation. Slight chemosis was observed on Day 7.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Initial pain reaction: slight initial pain was observed. Area cornea involved (opacity): one quarter (or less) but not zero (observed at the 1, 24 & 72 hours observation) & greater than one 1/4 but less than half (observed at the 48 hours observation).
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Slight inflammation of iris was observed at the 1 hour observation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Moderate conjunctivae redness was observed at the 1 hour observation. Slight conjunctivae redness was observed on Day 7.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Moderate chemosis was observed at the 1 hour observation. Slight chemosis was observed on Day 7.
Irritant / corrosive response data:
Reddish brown coloured staining of the fur caused by the brown test item was noted around both treated eyes during the study.
Diffuse corneal opacity was noted in both treated eyes one hour after treatment and at the 24, 48 and 72-Hour observations.
Iridial inflammation was noted in both treated eyes one hour after treatment and in one treated eye at the 24 and 48-Hour observations. Iridial inflammation developed again in one treated eye at the 72-Hour observation.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment and at the 24 and 48-Hour observations. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye at the 72-Hour observation with minimal conjunctival irritation noted in both treated eyes at the 7-Day observation.
Both treated eyes appeared normal at the 14-Day observation.
Other effects:
- Body weight: both animals showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test material is irritating to the eyes.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is classified as Category 2.