Alkane-alpha,omega-diyl bis{[(trimethoxysilyl)propyl]carbamate}_M3

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

2013-01-28 to 2013-02-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to ECHA Practical Guide 6 the maximum score for read across is rel. 2

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

1998

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: 
- Source: LPT, Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: female
- Age: approx. 4.5 to 5.5 months
- Weight at study initiation: 2.4 kg up to 2.7 kg
- Housing: single
- Diet: ad libitum, ssniff K-H (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: identical animal, second eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: identical animal, left eye

Amount / concentration applied:

Amount: 0.1 mL of the test item was administered per eye

Duration of treatment / exposure:

Single instillation into the conjunctival sac of the right eye, test item was not rinsed

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 female rabbits

Details on study design:

ADMINISTRATION: The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further
animals were employed 24 hours after start of the initial test.
0.1 mL of the test item was administered per eye and tested in three animals.
The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were
then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: test item was not rinsed
TOOL USED TO ASSESS SCORE: eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
At 24 hours after the administration, the eyes were treated additionally with fluorescein and examined.
SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0
- Conjunctivae (Chemosis): 0

Other effects:

no other effects

Any other information on results incl. tables

Acute eye irritation/corrosion test of the test item

 

Examination of the treated eye

Time after administration	C O R N E A	I R I S	C O N J U N C T I V A E
	Opacity		Redness^#	Chemosis^##
	A n i m a l n o. : 1 / 2 / 3
right eye: 100 ml test item
before dosing	0/0/0	0/0/0	0/0/0	0/0/0
1 hour	0/0/0	0/0/0	0/0/0	0/0/0
24 hours	0/0/0	0/0/0	0/0/0	0/0/0
48 hours	0/0/0	0/0/0	0/0/0	0/0/0
72 hours	0/0/0	0/0/0	0/0/0	0/0/0

Applicant's summary and conclusion

Conclusions:

The test substance was n o n - i r r i t a t i n g to eyes, hence, no labelling is required.

Executive summary:

The purpose of this study was to obtain information on the influence of the test item on rabbit eyes (irritation/corrosion test), according to OECD guideline 405, EC method B.5. and OCSPP guideline 870.2400.

Under the present test conditions a single administration of the test item per animal into the conjunctival sac of the right eye of three rabbits did not cause any changes.

Conjunctival redness, corneaeandirises were not affected by instillation of the test item. There were no systemic intolerance reactions.Therefore, according to the EC Regulatiom 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the test item is non-irritating to eyes, hence, no labelling is required.