reaction mass of bis(2-propylheptyl) hexanedioate and O6-[2,2-bis[[6-oxo-6-(2-propylheptoxy)hexanoyl]oxymethyl]butyl] O1-(2-propylheptyl) hexanedioate

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:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, for read-across justification refer to IUCLID section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan/MAFF 8147

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

XPB 115

IUPAC Name:

XPB 115

Constituent 2

Reference substance name:

Hexanedioic acid, bis(2-propylheptyl) ester

IUPAC Name:

Hexanedioic acid, bis(2-propylheptyl) ester

Constituent 3

Reference substance name:

Bis(2-propylheptyl) hexanedioate

EC Number:

940-510-9

Molecular formula:

C26 H50 O4

IUPAC Name:

Bis(2-propylheptyl) hexanedioate

Test material form:

other: liquid

Details on test material:

refer to confidential details on test material

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 3 months
- Weight at study initiation: 2.27 kg – 2.51 kg
- Housing: Single housing, Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

IN-LIFE DATES: From: 22 April 2014 To: 09 May 2014

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eyes of same animals used as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): unchanged

Duration of treatment / exposure:

24h

Observation period (in vivo):

96h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24h with warm tap water
- Time after start of exposure: 24h

SCORING SYSTEM: see "any other information on material and methods incl. tables"

TOOL USED TO ASSESS SCORE: hand-slit lamp, otoscope lamp, fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24h - 72h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h - 72h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24h - 72h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24h

Results 4

Irritation parameter:

other: discharge

Basis:

mean

Time point:

other: 24h - 72h

Max. score:

3

Reversibility:

fully reversible within: 24h

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24h - 72h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24h

Any other information on results incl. tables

No reactions on cornea or iris were observed in any animal during the observation period. Even after installation of fluorescein after 24 and 48 hours no corneal lesions were detectable. Slight conjunctival redness (grade 1) was noted in two animals at 1 hour after application. Slight conjunctival chemosis (grade 1) was noted in one animal at 1 hour after application. Severe discharge (grade 3) was noted in all animals at 1 hour after application. Additional findings like injected scleral vessels in a circumscribed area were noted at hour 1 after application only. The ocular reactions were reversible in all animals within 24 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.0, 0.0 and 0.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU