Isooctadecanoic acid, monoester with propane-1,2-diol

Endpoint summary

Description of key information

Skin, rabbit (OECD 404): not irritating

Eye, rabbit (OECD 405): not irritating

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Jun to 08 Aug 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

yes

Remarks:

purity not reported; assessed 24, 48 and 72h after application, not after patch removal

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

Limited documentation details, no rationale for in vivo testing

Qualifier:

according to guideline

Guideline:

other: 67/548/CEE

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage des Feuilletas
- Age at study initiation: not given
- Weight at study initiation: 2 +/- 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm), grid floor
- Diet: rabbit feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5
- Humidity (%): 55 +/- 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 27 Jun to 03 Jul 1989

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

with a fine comb electric clipper to obtain a skin area of approx. 14 x 14 cm

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral side was applied with distilled water as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): unchanged

Duration of treatment / exposure:

4h

Observation period:

7 days
Readings at 24h, 48h, 72h, 6d, and 7d after application and at 1h after removal of dressing

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm² square
- Type of wrap if used: Test substance (or water on contralateral body side) was applied on a Codex hydrophilic eight layer gauze, about 2.5 cm², which was laid down on the skin. The gauze was kept in contact with skin using a hypoallergenic microporous adhesive strip. The whole was then covered with a stretchable band (fixed with adhesive tape) wrapped round the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

OBSERVATION TIME POINTS
1 hour after removal of dressing; 24 hours, 48 hours, 72 hours, 6 days, and 7 days after application

SCORING SYSTEM:
- Method of calculation: erythema and edema scores from 0-4.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal: #1 and #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Three animals were tested.
The individual mean erythema scores over 24/48/72 hours were 0.66, 0.66, and 1.0.
The individual mean oedema scores over 24/48/72 hours were 0.33, 0.0, and 0.0.

Erythema Draize scores, 4h semi-occlusive, 0.5 mL unchanged test substance, NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	1	1	0	0	0
2	1	1	0	0	0
3	1	1	1	0	0

Oedema Draize scores, 4h semi-occlusive, 0.5 mL unchanged test substance, NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	0	0	0	0	0
2	1	0	0	0	0
3	0	0	0	0	0

Erythema Draize scores, 4h semi-occlusive, 0.5 mL aqua dest., NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0

Oedema Draize scores, 4h semi-occlusive, 0.5 mL aqua dest., NZW rabbits

Animal #	24 h	48 h	72 h	Day 6	Day 7
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0

 

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

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:

experimental study

Adequacy of study:

key study

Study period:

26 Jun to 08 Aug 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

no purity reported

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

Limited documentation, no in vivo testing rationale

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage des Feuilletas
- Age at study initiation: not given
- Weight at study initiation: 2 +/- 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm), grid floor
- Diet: rabbit feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5
- Humidity (%): 55 +/- 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 26 Jun to 03 Jul 1989

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): unchanged product as provided by sponsor

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

72 hours
Readings at 1h, 24h, 48h, and 72h after instillation

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Chemosis (0-4), Conjunctiva redness (0-3), Iris (0-2), Cornea opacity (0-4)
Eyes were assessed 1, 24, 48 and 72 hours after instillation

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Single instillation, 0.1 mL unchanged test substance, NZW rabbits

Conjunctivae Draize score

Animal #	24h	48h	72h
1	0	0	0
2	1	0	0
3	0	0	0

Iris Draize score

Animal #	24h	48h	72h
1	0	0	0
2	0	0	0
3	0	0	0

Chemosis Draize score

Animal #	24h	48h	72h
1	0	0	0
2	0	0	0
3	0	0	0

Corneal opacity Draize score

Animal #	24h	48h	72h
1	0	0	0
2	0	0	0
3	0	0	0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Skin irritation

A skin irritation study was conducted with Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) according to OECD guideline 404 under GLP conditions (key, 1989). 0.5 mL of the liquid test substance was applied to the clipped skin of 3 New Zealand White rabbits for 4 hours of exposure under semi-occlusive conditions. The skin irritation effects were scored 1, 20, 44 and 68 hours after patch removal. Slight erythema (score 1) was found in 3/3 at 24 and 48 hours after application and in 1/3 animal at 72 hours after application. No erythema was found 6 and 7 days after application. The individual mean erythema scores over 24/48/72 hours were 0.66, 0.66, and 1.0. Slight oedema was found in 1/3 animals at 24 hours after application. The individual mean oedema scores over 24/48/72 hours were 0.33, 0.0, and 0.0. The results of the study did not meet CLP/EU GHS criteria for a skin irritating potential.

 

Eye irritation

Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) was examined for its eye irritation potential in a study performed according to OECD guideline 405 under GLP conditions (key, 1989). 0.1 mL of undiluted test substance was instilled into one eye of each of 3 New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours after instillation. Slight conjunctival redness (score 1) was seen in 1/3 rabbits at 24 hours. The effect had cleared completely within 48 hours. The individual mean conjunctivae scores over 24/48/72 hours were 0.33, 0.0, and 0.0. No other eye irritation effects were observed in any rabbit at any time point. The individual mean iris, chemosis, and cornea opacity scores over 24/48/72 hours were 0.0 in all three animals. Under the conditions of the study, the test substance showed no eye irritating potential.

 

Overall conclusion for skin and eye irritation

No skin or eye irritation potential was shown for Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0).

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.