Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate

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:

20 November 20 1990 - 23 November 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD Guideline. Limited details on test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Limited details on test substance

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate

EC Number:

234-392-1

EC Name:

Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate

Cas Number:

11138-60-6

IUPAC Name:

2,2-bis[(octanoyloxy)methyl]butyl decanoate

Test material form:

other: liquid

Details on test material:

- Physical state: Colourless liquid
- Lot/batch No.: 0145/401
- Other: pH 6-7

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle
- Weight at study initiation: 2.6 kg
- Housing: individually
- Diet: ad libitum; Rabbits substance ref. 112 C
- Water: ad libitum
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

single dose, no rinsing

Observation period (in vivo):

3 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: according to 84/499/EEC appendix V B5

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

3

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

2

Reversibility:

other: other: no effects

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24 h, 48 h and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Any other information on results incl. tables

Animal	Hours after application
	1					24					48					72
	A	B	C	D	E	A	B	C	D	E	A	B	C	D	E	A	B	C	D	E
01	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
02	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
03	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

A = Cornea Score

B = Iris Score

C = Erythema Score

D = Chemosis Score

E = Exsudation Score

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an in vivo study in New Zealand White rabbits, read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, was not classified as an eye irritant.