Reaction products from the esterification of neopentylglycol with fatty acids, C16-18 (even numbered) and C18-unsatd. and fatty acids, C18-unsaturated, dimers

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

GIPC, Ivry-Sur-Seine, France

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyl-1,3-propanediyl dioleate

EC Number:

255-713-1

EC Name:

2,2-dimethyl-1,3-propanediyl dioleate

Cas Number:

42222-50-4

IUPAC Name:

2,2-dimethylpropane-1,3-diyl bisoctadec-9-enoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 2,2-dimethyl-1,3-propanediyl dioleate
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: OE 10124A
- Expiration date of the lot/batch: 24 Jan 2013

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gerome, Linxe, France
- Age at study initiation: 13 weeks
- Weight at study initiation: 2.39-3.06 kg (range)
- Housing: individually in box
- Water: foodstuff (Safe-112), ad libitum
- Diet: drinking water (tap water from public distribution system), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of three animals

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of three animals

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: within 3 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h

Score:

0.7

Max. score:

3

Reversibility:

other: 72 hours

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of three animals

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The conjuctivae reactions observed during the study have been slight to moderate and totally reversible: a moderate redness noted 1 h after the test item instillation in all animals and totally reversible on Day 3, associated with a slight chemosis noted 1 h after the test item instillation in two animals and totally reversible on Day 1.

Any other information on results incl. tables

Table 1. Individual and mean scores of conjuctivae, iris and cornea

Animal n°	Time after treatment	CONJUNCTIVAE		IRIS	CORNEA
		Chemosis (A)	Redness (C)	Lesion (D)	Opacity (E)
A2697	24 hours	0	2	0	0
	48 hours	0	1	0	0
	72 hours	0	0	0	0
Mean		0.0	1.0	0.0	0.0
A2698	24 hours	0	2	0	0
	48 hours	0	1	0	0
	72 hours	0	0	0	0
Mean		0.0	1.0	0.0	0.0
A2699	24 hours	0	1	0	0
	48 hours	0	1	0	0
	72 hours	0	0	0	0
Mean		0.0	0.7	0.0	0.0

 

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