Mono- and/or di- and/or tri(1-phenylethyl)-m-cresol and p-cresol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Atlen SK

IUPAC Name:

Atlen SK

Details on test material:

- Name of test material (as cited in study report): Atlen SK
- Substance type: organic, UVCB
- Physical state: liquid
- Lot/batch No.: probka of 12-12-2008
- Expiration date of the lot/batch: 2009-12-13
- Stability under test conditions: stable

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zeland

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Reproductive Farm of Rabbits, Balice, Poland
- Age at study initiation: 5.5 months (rabbit No. 1) and 6 months (rabbits No. 2 and No. 3)
- Weight at study initiation: rabbit No. 1 - 3.3 kg, rabbit No. 2 - 3.2 kg, rabbit No. 3 - 3.0 kg
- Housing: animals were kept individually in metal cages of dimensions (length x width x height) 60 x 35 x 40 cm. The cages were equipped with lables containing information on study code, the date of the beginning and of the end of the experiment, sex and animal's number.
- Diet (e.g. ad libitum): ad libitum. The animals were fed standard granulate feed "LSK" produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz, Poland
- Water (e.g. ad libitum): ad libitum. Tap water.
- Acclimation period: 5 days quarantine

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 43 - 55 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml was administered in uniluted form

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was not performed

SCORING SYSTEM: according to the OECD TGD No. 405

TOOL USED TO ASSESS SCORE: the character of changes made application of any tools unnecessary - the changes were visible with a naked eye

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: average of 24, 48 and 72 hrs

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 14 d

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: average of 24, 48 and 72 hrs

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: average of 24, 48 and 72 hrs

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: average of 24, 48 and 72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: average of 24, 48 and 72 hrs

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: average of 24, 48 and 72 hrs

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: average of 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable, as no effects were seen

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: average of 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable, as no effects were seen

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: average of 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable, as no effects were seen

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: average of 24, 48 and 72 hrs

Score:

0

Max. score:

2

Reversibility:

other: not applicable, as no effects were seen

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: average of 24, 48 and 72 hrs

Score:

0

Max. score:

2

Reversibility:

other: not applicable, as no effects were seen

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: average of 24, 48 and 72 hrs

Score:

0

Max. score:

2

Reversibility:

other: not applicable, as no effects were seen

Irritant / corrosive response data:

After administration of test item pathological changes were stated in conjunctiva of eyes of rabbits. No changes in cornea and iris were observed.
During reading after 1 hour since administration of test item erythema in form of diffuse crimson redness (individual vessels hardly visible) was stated in conjunctiva of rabbit No 1 and No 3, whereas erythema in form of diffuse beefy redness was observed in rabbit No 2. Furthermore, congestion of nictating membrane and circumcorneal injection were stated in three rabbits. Distinct swelling of conjunctiva with partial eversion of eyelids was observed in rabbit No 1 and rabbit No 3. Swelling of nictating membrane was stated in three rabbits. Excretion on lids, lids’ hair and considerable part of eye region was stated in rabbit No 1, excretion on lids and lids’ hair in rabbit No 2 and No 3.
During reading after 24 hours since administration of test item erythema in form of diffuse crimson redness, congestion of nictating membrane, circumcorneal injection as well as swelling of nictating membrane and excretion on lids and lids’ hair were stated in conjuctivas of three rabbits. Slight swelling of conjunctiva was observed in rabbit No 1 only.
During reading after 48 hours since administration of test item erythema in form of diffuse crimson redness was observed in conjunctiva of rabbit No 1, injection of some blood vessels was stated in rabbit No 2 and No 3. Congestion of nictating membrane was stated in three rabbits. Swelling of nictating membrane and slight volumes of excretion were observed in rabbit No 1 and No 2.
During reading after 72 hours since administration of test item congestion of some blood vessels and congestion of nictating membrane were stated in three rabbits. Swelling of nictating membrane and slight volumes of excretion were observed only in rabbit No 1.
During reading after 7 days since administration of test item congestion of some blood vessels was stated in rabbit No 1. No pathological changes were stated in eyes of the remaining two rabbits.
During reading after 14 days since administration of test item no pathological changes were observed in conjunctiva of rabbits.
See Table 1 in section any other information on results incl. tables for the recorded scores.