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

Endpoint summary

Description of key information

By read-across, heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate is considered to be not irritant to either the skin or the eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

November 13th, 1990 - November 16th, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD Guideline.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack of details on test substance

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elvage Cunicole du Val de Selle, France
- Weight at study initiation: 2.3 kg
- Diet: ad libitum; Rabbit 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm², flanks were clipped a day before treatment
- Type of wrap if used: adhesive hypoallergic aerated semi-occlusive dressing (Laboratories de Pansements et d´Hygiène, France)


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


SCORING SYSTEM:According to Draize

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No cutaneous effects observed

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no cutaneous effects observed

Erythema score

Animal Number	1 h	24 h	48 h	72 h
O1	0	0	0	0
O2	0	0	0	0
O3	0	0	0	0

Edema Score

Animal Number	1 h	24 h	48 h	72 h
O1	0	0	0	0
O2	0	0	0	0
O3	0	0	0	0

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 a skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Limited details on test substance

GLP compliance:

yes

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

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

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an in vivo study in New Zealand White rabbits conducted according to OECD Guideline 404, read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, was not classified as a skin irritant.

In an in vivo study in New Zealand White rabbits conducted according to OECD Guideline 405, read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, was not classified as an eye irritant.

In conclusion, by read-across, heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate is considered to be not irritant to either the skin or the eyes.

Justification for selection of skin irritation / corrosion endpoint:
Only 1 study is available

Justification for selection of eye irritation endpoint:
Only 1 study is available

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).