Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 January to 08 February 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant with current guidelines and GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

EC Number:

903-162-9

IUPAC Name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Details on test material:

- Name of test material (as cited in study report): EC 903-162-9
- Physical state: Dark brown/black viscous liquid
- Analytical purity: Purity not applicable because the test item was a mixture of 100% UVCB Registration substance and solvent oil *
- Lot/batch No.: LN07006926
- Expiration date of the lot/batch: 19 December 2013
- Storage condition of test material: Ambient temperature, in the dark

*EC 903-162-9 is exclusively synthesised and handled in solvent oil. Therefore testing was conducted on a sample that contained 40.8% Base oil and 59.2% EC 903-162-9.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Born at Charles River, Edinburgh
- Age at study initiation: Approximately 9 months old
- Weight at study initiation: 4.525 kg and 4.127 kg
- Housing: Singly housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C on each day
- Humidity (%): 42% to 58%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark

IN-LIFE DATES: From: To: 29 January to 08 February 2013

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
- Concentration (if solution): Not applicable

Duration of treatment / exposure:

Single dose

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

Two

Details on study design:

REMOVAL OF TEST MATERIAL
- Washing (if done): None

SCORING SYSTEM:
OECD Test Guideline scoring system
TOOL USED TO ASSESS SCORE: Hand held magnifier and pen torch (when necessary). When required only, fluorescein and ultraviolet illumination

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Other effects:

Slight ocular discharge at 1 h and 4 h post instillation

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Using the criteria described in regulation (EC) 1272/2008, under the conditions of the study, EC 903-162-9 would be considered to be non-irritating to the rabbit eye.

This study is considered to be relevant, reliable and adequate for risk assessment and for classification purposes.

Executive summary:

This study investigated the eye irritation potential of EC-903-162-9 after a single instillation to the rabbit eye.

Two female rabbits received 0.1 mL of EC-903-162-9, instilled, as supplied, into the conjunctival sac of the right eye. The left eye remained untreated and hence it acted as a control. Both eyes were examined for evidence of irritation approximately 1, 4, 24, 48 and 72 h after instillation.

No irritation was noted in the control eyes of either rabbit at any observation timepoint.

There were no reactions in the iris of either animal. Corneal opacity, slight conjunctival redness and a slight discharge were noted 1 h after test item instillation in one animal. However, after the eye was stained with Fluorescein and the eye examined under ultraviolet illumination, no area of opacity was found. Slight discharge was noted 4 h after test item instillation in both animals.

Using the criteria described in the European Union Council Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP) under the conditions of the study, EC-903-162-9 would be considered to be non-irritating to the rabbit eye.