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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E15-01025
- Expiration date of the lot/batch: 31 Jan 2035
- Purity test date: Jan 2015


OTHER SPECIFICS:
- Appearance: black solid
- Purity: 100%
- Storage conditions: controlled room temperature (15-25°C, <70 RH%)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: S&K LAP Kft, 2173 kartal, Csaszar ut 135, Hungary
- Age at study initiation: 13-14 weeks old
- Sex: Male
- Weight at study initiation: 3366-3728g
- Housing: individually housed in AAALAC approved metal wire rabbit cages of an open wire structure and placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet (e.g. ad libitum): ad libitum UNI diet for rabbits, produced by Cargill Takarmany Zrt, 5300 Karcag, Madarasi ut 0399, Hungary.
- Water (e.g. ad libitum): ad libitum municipal tap water from an automatic system
- Acclimation period: at least 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19,0 - 24,1 °C
- Humidity (%):36-79%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12h light, from 6.00 am to 6.00 pm

Test system

Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 single dose of 0.1g test item


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- test item was placed into the conjunctival sac of the left eye.
- pH was assessed by measurement of the supernatant from a 1ù w/v mixture in distilled water according to CIPAC MT75. pH was found to be 5.0 (and permitted for use in animal studies).

OTHER MATERIALS USED
- For washing: disposable syringe luer solo 20 ml, NaCl 0.9%
- Systemic opiate analgesic: Bupaq 0.3 mg/ml
- Topical ocular anaesthetic: Humacain 4 mg/ml
- Nonsteroidal anti-inflammatory drug: Metacam 5 mg/ml
- Euthanasia: Ketamidor, Primazin 2%, Euthanimal 40% (pentabarbital sodium)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: conjunctival redness
Basis:
animal: 1, 2 and 3
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal: 1, 2 and 3
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
other: conjunctival redness
Basis:
animal: 1, 2 and 3
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48h

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item GASIR5, applied to rabbit eye mucosa, caused conjunctival effects at 1 hour after application which were fully reversible within 48 hours.
According to Regulation EC 1272/2008, GASITR5 does not require classification as an eye irritant.
Executive summary:

An acute eye irritation study of the test item GASIR5 was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2012). Rabbits were treated with analgesic and anaesthetic as per the regulatory guideline. Three animals were used to make the classification.

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single amount of 0.1 g of the test item was administered as a single dose.

The eyes were examined at 1, 24, 48 and 72 hours after application.

No Initial Pain Reaction(IPR) or any Pain Reaction (PR) was observed during the experimental period.

Animal 1 (No: 405) clinical observation

At one hour after the application, conjunctival redness (score 2), chemosis (score 1) and discharge (score 2) were noted in the rabbit. Test item remained in the eye sac.
At 24 hour after the application,conjunctival redness (score 1) was observed in the rabbit.

At 48 and 72 hours after the application,no clinical signs, and no conjunctival or corneal effects were observed.

Animal 2 (No: 421) clinical observation

At one hour after the application, conjunctival redness (score 2), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.
At 24 hour after the application,conjunctival redness (score 1) was observed in the rabbit.

At 48 and 72 hours after the application,no clinical signs, and no conjunctival or corneal effects were observed.

Animal 3 (No: 397) clinical observation

At one hour after the application, conjunctival redness (score 2), chemosis (score 1) and discharge (score 1) were noted in the rabbit. Test item remained in the eye sac.
At 24 hour after the application,conjunctival redness (score 1) was observed in the rabbit.

At 48 and 72 hours after the application,no clinical signs, and no conjunctival or corneal effects were observed.

In all animals the fur around the treated eye was coloured black by the test item at 1, 24, 48 and 72 hours after the application.

As no clinical signs were observed, the experiment was terminated after 72 hours observation. During the experiment, the control eye of each animal was symptom-free.
The general state and behaviour of animals were normal throughout the study period.
No mortality occurred during the study. The bodyweights of all rabbits were considered to be within the normal range of variability.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

Chemosis Discharge Redness Cornea Iris

Animal 1 0.00 0.00 0.33 0.00 0.00

Animal 2 0.00 0.00 0.33 0.00 0.00

Animal 3 0.00 0.00 0.33 0.00 0.00

The test item GASIR5, applied to rabbit eye mucosa, caused conjunctival effects at one hour after application which were fully reversible within 48 hours.

According to Regulation (EC) No 1272/2008, GASIR5 does not require classification as an eye irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, GASIR5 does not require classification as an eye irritant.