2,2-dimethyl-1,3-propanediyl dioctanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

23 Jul - 04 Aug 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test material

Test material information

Constituent 1

Reference substance name:

Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol

EC Number:

272-469-1

EC Name:

Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol

Cas Number:

68855-18-5

Molecular formula:

C19H36O4

IUPAC Name:

Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol

Details on test material:

- Name of test material (as cited in study report): Heptanoic acid diester of neopentylglycol
- Physical state: clear colourless liquid
- Analytical purity: > 99%
- Purity test date: 2011-10-10
- Lot/batch No.: 595859
- Expiration date of the lot/batch: 2013-10-08
- Storage condition of test material: at room temperature, in the dark

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand White (Hsdlf:NZW)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.53-2.98 kg
- Housing: animals were housed in suspended cages with environmental enrichment items.
- Diet: Harlan 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd, Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

2 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No effects on the cornea or iris were noted in the animals. Moderate (grade 2) conjunctival irritation was noted in both animals 1 h after treatment. At the 24 h reading time point, only minimal conjunctival irritation (grade 1) was present in the animals, which was fully reversible 48 h after test substance application.

Other effects:

No other effects are reported.

Any other information on results incl. tables

RESULTS - MEASUREMENT OF PH

Table 1. Measurement of pH prior to commencement of the study

Preparation	Time point of pH measurement
	immediately	after 10 min
Undiluted	8.2	not applicable
90% (v/v) solution	8.6	8.5

BODY WEIGHTS

Both animals showed the expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified