Reaction mass of 7539-04-0 and pentaerythritol tetrakis(3-mercaptopropionate) and 2-{3-(3-mercaptopropionyl)thiopropionyl}oxymethyl-2-(3-mercaptopropionyl)oxymethyl-1,3-propanediyl bis(3-mercaptopropionate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02JUL1992 - 09JUL1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1987), referenced as Method B5 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

date of inspection: 17MAR1992

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 7539-04-0 and pentaerythritol tetrakis(3-mercaptopropionate) and 2-{3-(3-mercaptopropionyl)thiopropionyl}oxymethyl-2-(3-mercaptopropionyl)oxymethyl-1,3-propanediyl bis(3-mercaptopropionate)

Molecular formula:

not applicable (generic description of the multi-constituent)

IUPAC Name:

Reaction mass of 7539-04-0 and pentaerythritol tetrakis(3-mercaptopropionate) and 2-{3-(3-mercaptopropionyl)thiopropionyl}oxymethyl-2-(3-mercaptopropionyl)oxymethyl-1,3-propanediyl bis(3-mercaptopropionate)

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): PEMP (2,2-Dimethylpropanetatryl tetrakis (3-mercaptopropionate))
- Substance type: Organic
- Physical state: Pale yellow clear liquid with sulfur odor
- Storage condition of test material: Room temperature under nitrogen, shielded from light
- No information on purity

Specific details on test material used for the study:

The test was performed with PEMP product, the registered substance.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, United Kingdom
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.90 - 3.48 kg
- Housing: individually, in suspended metal cages
- Diet: ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, United Kingdom)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 58-66
- Air changes (per hr): appr. 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 02JUL1992 to 09JUL1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye was used as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1mL

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to Draize, JH (1959), Association of Food and Drug Officials of the United States, Austin, Texas: "The Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics".

TOOL USED TO ASSESS SCORE: standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

3

Irritant / corrosive response data:

No adverse corneal or iridial effects were noted. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours. No other adverse ocular effects were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. As no adverse effects were seen in the treated eyes at 24, 48 and 72 hours, PEMP was found to be not irritating to the eye.

Executive summary:

An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours.No adverse corneal or iridial effects were noted at any timepoint. No other effects were noted. Based on the results of this study, PEMP was found to be not irritating to the eye.