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Diss Factsheets

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:
2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Eurofins Advinus Limited, Bengaluru-560058
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.6377 to 2.7593 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: L 65 x B 65 xH 45 cm) with noryl shallow cage body and facilities for pelleted food (Stainless steel feed hopper) and drinking water (750 mL markrolon bottle fitted with sipper tube). The perforated noryl raised shelf for enrichment was provided. The litter collection trays (noryl waste tray) were changed daily (except on Sunday). The water bottles and feed hoppers were changed once a week.

- Diet: The animals were offered rabbit feed manufactured Krishna Valley Agrotech LLP, MIDC Kupwad block, Sangli, Maharashtra.
- Water: Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India, was provided to animals in markrolon bottles with stainless steel sipper tubes.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 65 to 67
- Photoperiod (hrs dark / hrs light): 12 hour light and 12 hour dark cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
CORNEA
A: Opacity and degree of density (most dense area scored)
0 - No opacity
1 - Scattered or diffuse area, details of iris clearly visible
2 - Easily discernible translucent areas, details of iris slightly obscured
3 - Nacreous area; no details of iris visible; size of pupil barely discernible
4 - Opaque cornea; iris not discernible through the opacity

B: Area of cornea involved
1 - One quarter (or less) but not zero
2 - Greater than one quarter, but less than half
3 - Greater than half, but less than three quarters
4 - Greater than three quarters, up to whole area

IRIS
A: Values
0 - Normal
1 - Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect
2 - Haemorrhage, gross destruction, or no reaction to light


CONJUNCTIVAE
A: Redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
0 - Vessels normal
1 - Some blood vessels hyperaemic (injected)
2 - More diffuse, deeper crimson red, individual vessels not easily discernible
3 - Diffuse beefy red

B: Chemosis
0 - No swelling
1 - Any swelling above normal (includes nictitating membrane)
2 - Obvious swelling with partial eversion of lids
3 - Swelling with lids about half closed
4 - Swelling with lids about half closed to completely closed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
There were no clinical signs of toxicity and pre-terminal deaths.
The body weights of all rabbits increased during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the present study results the test item FAT 41047/A TE is “Non-Irritant” on the eye of New Zealand white rabbits.
Executive summary:

The acute eye irritation / corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation / corrosion potential of FAT 41047/A TE. This study was conducted in accordance with OECD 405 test guideline in a GLP compliant lab.

A single dose of the test item was instilled in to the conjunctival sac of the rabbit’s eye.

On test day one (treatment day), a quantity of 100 mg of finely ground test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. All the rabbits were treated in a similar manner.

The eyes of each rabbit were examined at 1, 24, 48 and 72 hours post-instillation and scored.

Mean corneal opacity, iris, conjuctival redness, chemosis score was 0. No irritation was observed. There were no clinical signs of toxicity and pre-terminal deaths and no abnormality was detected at necropsy in any of the animals.

Based on the present study results the test item FAT 41047/A TE is “Non-Irritant” on the eye of New Zealand white rabbits according to Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, as there were no eye reactions in any of the treated rabbits.