Reaction mass of 2-(1,1-dimethylethyl)-4-{[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio}-5-methylphenyl 3-(dodecylthio)propionate and thiobis[2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene] bis[3-(dodecylthio)propionate]

Eye irritation

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:

guideline study

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-(1,1-dimethylethyl)-4-{[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio}-5-methylphenyl 3-(dodecylthio)propionate and thiobis[2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene] bis[3-(dodecylthio)propionate]

EC Number:

940-594-7

Molecular formula:

C52H86O4S3 , C37H58O3S2

IUPAC Name:

Reaction mass of 2-(1,1-dimethylethyl)-4-{[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio}-5-methylphenyl 3-(dodecylthio)propionate and thiobis[2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene] bis[3-(dodecylthio)propionate]

Test material form:

liquid

Details on test material:

Intended use: Antioxidant for plastics
Appearance: Brown liquid
Storage conditions: Room temperature protected from light
Supplier: Sponsor
Lot number: 102Y1
Expiry date: 30 April 2014
Purity 98.8%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 40 weeks
- Weight at study initiation: 3.32 to 4.52 kg
- Housing: Each animal was housed individually in a plastic cage with perforated floors.
- Diet (e.g. ad libitum): 125 g of a standard laboratory rabbit diet per day
- Water (e.g. ad libitum): Drinking water was provided ad libitum.
- Acclimation period:All rabbits were acclimatised to the experimental environment for a period of 23 weeks prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):16 to 20°C
- Humidity (%):40 to 70%
- Photoperiod (hrs dark / hrs light):Lighting was controlled by means of a time switch to give 12 hours of artificial light (06:00 to 18:00 GMT) in each 24 hour period.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Three rabbits were each administered a single ocular dose of a volume of 0.1 mL of the test substance.

Duration of treatment / exposure:

The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation. Each animal was gently restrained. The dose was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated.

Observation period (in vivo):

The animals were returned to their cages and checked at least twice during the first hour after dosing and at regular intervals throughout the day to ensure no severe injury passed unnoticed. Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours after treatment.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Kay and Calandra

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h

Score:

4.7

Max. score:

4.7

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

0.7

Reversibility:

fully reversible

Irritant / corrosive response data:

Injection of the conjunctival blood vessels, very slight chemosis and slight discharge were apparent in the sentinel animal one hour after instillation; the conjunctival injection persisted throughout the first 48 hours after instillation. The treated eye was overtly normal 72 hours after instillation. Injection of the conjunctival blood vessels with slight discharge was evident in the remaining animals one hour after instillation; the treated eyes of these animals were overtly normal 24 hours after instillation. Instillation of the test material gave rise to practically no initial pain response.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There was no sign of toxicity or ill health in any rabbit during the observation period.

Executive summary:

The highest total mean score was 4.7 occurring at the 1 hour observation; accordingly under the criteria Kay and Calandra (1962) AO-26 was classified as “minimally irritating” to the eye however AO-26 does not require classfcation or labelling in accordance with European Commission regulation 1272/2008.