Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol

Endpoint summary

Description of key information

Skin irritation/corrosion: not irritating (OECD 404, category approach)
Eye irritation: not irritating (OECD 405, GLP)

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

Reference 1

Endpoint:

skin 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:

12 Jun 1991 - 15 Jun 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Analytical purity of test substance not specified, no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

analytical purity of test substance not specified, no experimental 48 h reading performed, 25 h exposure and occlusive dressing according to former guideline.

Qualifier:

according to guideline

Guideline:

other: FHSA (Federal Hazardous Substances Control Act), 16 CFR 1500.41

Deviations:

yes

Remarks:

25 instead of 24 h exposure.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet: pelleted, Purina Rabbit Chow , ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- concentration: undiluted and not moistened

Duration of treatment / exposure:

25 h

Observation period:

72 h
Reading time points: 25 and 72 h

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm² (see study report)
- Type of wrap if used: adhesive-backed gauze patches secured in place with an elastic wrapping.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped clean of any residual test material
- Time after start of exposure: 25 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritant / corrosive response data:

Intact skin:
No erythema or edema was observed in any animal during the study period.
Abraded skin:
After 25 h slight erythema formation was observed in 2/6 animals being fully reversible within 72 h.
No edema formation was observed in any animal during the study period.

Other effects:

All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

Interpretation of results:

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

Reference 2

Endpoint:

skin 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:

16 Dec - 19 Dec 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Lack of experimental and test material details.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of experimental and test material details

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Chesire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.19-2.49 kg
- Housing: individually housed in suspended metal cages
- Diet: Rabbit Diet (Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-18
- Humidity (%): 55-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

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

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm² on the dorsal flank area
- Type of wrap if used: The treated skin was covered with a gauze patch and held in place with a strip of surgical adhesive tape. Additionally, the trunk of the animal was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gently swabbing with cotton wool soaked in distilled water and diethyl ether.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

24 h after removal of the test substance slight erythema in 1/3 animals was observed which was fully reversible within 48 h. The remaining animals revealed no erythema formation. No edema was observed during the study period in any animal.

Other effects:

No further local or systemic effects were reported.

Interpretation of results:

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

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Occlusive dressing according to former guideline, only 40% solution applied, no experimental 48 h reading performed.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive dressing according to former guideline, only 40% solution applied, no experimental 48 h reading performed

Qualifier:

according to guideline

Guideline:

other: Journal Officiel de la Republique Francaise of 21/4/71 and 5/6/73

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: individually housed in cages or restraining devices which allow the back of the animals to be treated
- Diet: 200 g/day/animal in the form of granules (Granules Lapin Entretien SANDERS)
- Water: ad libitum
- Vaccination: myxomatosis and pasteurellosis

ENVIRONMENTAL CONDITIONS
- air-conditioned

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

other: olive oil

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% (v/v)

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points: 24 and 72 h

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: left flank and right flank (scarified); shaved: 14 cm x 14 cm, patch size: 2 cm x 2 cm
- Type of wrap if used: The treated skin was covered with gauze, held in place with a "NEDDERMOTEST ROC"-patch, and an adhesive tape.

SCORING SYSTEM: Primary irritation index

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritant / corrosive response data:

Intact skin:
2/6 animals showed slight erythema after 24 h which were fully reversible within 72 h.
Abraded skin:
In 5/6 slight irritating effects were observed after 24 h being fully reversible within 72 h.

No edema formation was apparent in any animal during the study period.

Other effects:

No other local or sytemic effects were reported.

Table 1. Results of skin irritation study. 

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	1	0	0	0	0	0	1	0	0	0	0	0
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h	0	0	0	0	0	0	0	0	0	0	0	0

 

Table 2. Calculation of mean scores.

	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	0,67	0,00	0,00	0,00	0,00	0,00	0,67	0,00	0,00	0,00	0,00	0,00

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

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:

21 May - 24 May 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 4 months
- Weight at study initiation: 2370 g
- Housing: individually housed in cages (E. Becker & Co)
- Diet: Ssniff rabbit diet K4 Charge: 66029126 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was rinsed with tepid tap water.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Cornea/ Iris: No effects on cornea/iris were observed in any animal during the study period.
Conjunctivae: After 1 and 24 h 2/3 animals showed slight erythema being fully reversible within 48 h.
Chemosis: In 1/3 animals slight chemosis was observed after 1 h being fully reversible within 24 h. No further edema formation was observed during the study period in any animal.

Other effects:

No further local or system effects were reported.

Table 1. Results of eye irritation study.

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0
2	1	1	0	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.0	0.0	0.0
3	1	1	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.0	0.0	0.0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	0.67	0.33	0.00	0.00
	24	0.67	0.00	0.00	0.00
	48	0.00	0.00	0.00	0.00
	72	0.00	0.00	0.00	0.00
	24+48+72	0.22	0.00	0.00	0.00

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 and Eye Irritation

Skin irritation

CAS 627-83-8

The skin irritation properties of ethylene distearate have been investigated in several studies (CAS 627-83-8).

The skin irritation properties of ethylene distearate were tested in a study equivalent to OECD guideline 404 (Product Safety Labs, 1991a). In the study, 3 male and 3 female New Zealand White rabbits were exposed to 0.5 g of the unchanged test substance, applied to the shaved and abraded skin for 25 h using an occlusive dressing. The treated skin was observed and evaluated at 25 and 72 h post-application. No erythema or edema was observed in any animal during the study period on intact shaved skin. On abraded skin, slight erythema in 2 animals was observed at 25 h, being fully reversible within 72 h. No further local or systemic effects were apparent in any animal during the study period.

In an equivalently conducted study from the same laboratory (Product Safety Labs, 1991b), the results of the above discussed study were confirmed. No erythema and no edema formation were observed in the test animals on intact skin and erythema on abraded skin was fully reversible within 72 h. No other local or systemic effects were described.

Additionally, the skin irritating properties of ethylene distearate were tested similarly to OECD guideline 404 in New Zealand rabbits and according to Draize type procedures with no further details in rabbits (Siege Social-Laboratoire, 1995; HPV, 1982). The test animals showed no reactions on skin during the study period and no other local or systemic effects were reported ( Siege Social-Laboratoire, 1995). In the studies with Draize type procedures, no effects on skin or slight skin reactions were described. According to the author, the test substance was therefore found to be non-irritating to slightly irritating.

In summary, ethylene distearate is not irritating to the skin.

 

CAS 68583-51-7

Several animal studies and one human patch test investigating the skin irritation properties of Decanoic acid mixed diesters with octanoic acid and propylene glycol are available.

The skin irritation properties of Decanoic acid, mixed diesters with octanoic acid and propylene glycol were tested in a study according to OECD guideline 404 in compliance with GLP (Safepharm Laboratories, 1989). In the study, 3 New Zealand White rabbits were exposed to 0.5 mL of the undiluted test substance, applied to the shaved skin for 4 h using a semiocclusive dressing. The treated skin was observed and evaluated at 1, 24, 48 and 72 h post-application. In 1/3 animals 24 h after removal of the test substance, slight erythema was observed which was fully reversible within 48 h (mean erythema score 0.3 after 24-72 h). The remaining animals revealed no erythema formation. No edema formation (mean over 24, 48 and 72 h) or further local or systemic effects were apparent in any animal during the study period.

Four further studies are available, in which the skin irritating properties of Decanoic acid, mixed diesters with octanoic acid and propylene glycol were studied in rabbits (Safepharm Laboratories, 1988; Henkel, 1988, EViC-CEBA Laboratory, 1985 and Consultox Laboratories Ltd., 1972).

In each study, 3-6 rabbits were exposed to 0.5 mL of the undiluted test material, applied to the shaved or abraded skin for 4 h or 24 h using a semi-occlusive or occlusive dressing. The treated skin was observed for reactions after patch removal and evaluations were made at 1, 24 and 72 h or at 1, 24, 48 and 72 h post-application.

In the first study, slight erythema with a mean erythema score of 0.2 over 24, 48 and 72 h out of all 3 animals were observed with all effects being fully reversible within 48 h. No edema formation was observed during the study period in any animal (Safepharm Laboratories, 1988). In the second study, the observed skin reaction consisted of slight to well defined erythema with a mean erythema score of 1.25 over 24, 48 and 72 h out of all 4 animals. All skin redness was fully reversible within 7 days. Slight edema formation was apparent with a mean edema score of 0.55 over 24, 48 and 72 h out of all 4 animals being fully reversible within 7 days (Henkel, 1988).In the third study, slight erythema was observed with a mean erythema score of 0.44 over 24, 48 and 72 h out of all 6 animals. The erythema formation in 3/6 animals was not fully reversible within the observation period of 72 h. No edema formation was observed during the study period in any animal (EViC-CEBA Laboratory, 1985). In the fourth study, no skin reactions and no further local or systemic effects were observed during the study period in any animal (Consultox Laboratories Ltd., 1971).

Furthermore, one human patch test is available investigating the skin irritation properties of Decanoic acid, mixed diesters with octanoic acid and propylene glycol after a single dermal application (Clinical university center Kiel, 1976).

The human patch test with the test substance was performed on 120 volunteers under occlusive conditions. The undiluted test material was applied to the back of the test subjects under occlusive conditions. After 24 h the test plaster was removed and skin reactions were observed 24, 48 and 72 h after application. No clinical signs and no skin reaction were observed in any volunteer during the study period.

Thus, good skin compatibility of the test substance was observed in the study.

 

In summary, Decanoic acid, mixed diesters with octanoic acid and propylene glycol is not skin irritating to the skin.

 

CAS 84988-75-0 and CAS 624-03-3

No studies are available investigating the skin irritating properties of Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (CAS 84988-75-0) and ethane-1,2-diyl palmitate (CAS 624-03-3). In order to fulfil the standard information requirements set out in Annex VII, 8.1, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 read-across from the structurally related category members ethylene distearate (CAS 627-83-8) and Decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) was conducted.

The studies from the category members ethylene distearate and Decanoic acid, mixed diesters with octanoic acid and propylene glycol are described under the respective CAS numbers.

Fatty acids, C16-18, esters with ethylene glycol was tested in a study according to OECD guideline 404 in compliance with GLP (Gattefosse, 1976). In the study, 6 New Zealand White male rabbits were exposed to 0.5 mL of the test substance in olive oil, applied to the shaved and abraded skin for 24 h using an occlusive dressing. The treated skin was observed and evaluated at 24 and 72 h post-application. On intact skin, 2/6 animals showed slight erythema (on abraded skin 5/6 showed slight irritating effects) after 24 h which were fully reversible within 72 h (mean erythema score over 24 and 72 h out of all 6 animals = 0.22). No edema formation or further local or systemic effects were apparent in any animal during the study period. In summary, no skin irritating properties of the category members were apparent, therefore interpolation to Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol and ethane-1,2-diyl palmitate, does not assume any skin irritating properties.

 

Additional data

In addition to the above discussed studies, two skin irritation studies of the category members Fatty acids, C18 and C18 unsatd. epoxidized, ester with ethylene (CAS 151661-88-0) and Glycol Stearate (CAS 111-60-4) are available, showing no skin irritation, as well.

 

Conclusion of skin irritation properties

In conclusion, the skin irritation properties of several Glycol Ester category members have been investigated in vivo indicating no or low skin irritating properties. Therefore, none of the category members of the Glycol Ester group is skin irritating.

 

Eye irritation

CAS 627-83-8

Several studies investigating the eye irritation properties of ethylene distearate are available.

The eye irritation properties of ethylene distearate were tested in a study similarly performed to OECD guideline 405 (Product Safety Labs, 1991a). In a group of 6 New Zealand white rabbits, 0.1 g of the test substance was applied into the eye. Observation of the eyes was performed 24, 48 and 72 h after application. No effects on cornea and iris were noted in any animal during the study period. However, mild conjunctival redness was observed in 4/6 animals after 24 h and in 2/6 animals moderate redness was apparent. In 2 animals the mild redness was still persistent after 72 h with a mean score of 0.78 over 24, 48 and 72 h out of all 6 animals. Chemosis was observed in 1/6 animals after 24 h being fully reversible within 48 h. No chemosis was observed in the remaining 5 animals during the study period. No further systemic effects or abnormal behaviour were observed in any animal during the study period.

An additional study of the same laboratory with ethylene distearate similarly to OECD guideline 405 was conducted (Product Safety Labs, 1991b). No effects on cornea and iris were apparent in any animal during the study period and no chemosis was observed in the test animals. Mild to moderate conjunctival redness was observed in all animals being fully reversible within 72 h post-instillation with a mean score of 0.61 over 24, 48 and 72 h out of all 6 animals. No further local or systemic signs of toxicity were apparent in the test animals.

Further studies are available investigating the eye irritating properties of ethylene distearate in rabbits according to OECD guideline 405 or according to Draize type procedures without further details (Siege Social-Laboratoire, 1995; HPV 1982). According to the author, the test substance was practically non-irritating or not an irritant in the test animals using the Draize type procedure (HPV, 1982). In the study by Siege Social-Laboratoire (1995), no effects on cornea and iris were apparent and conjunctival redness was observed in all animals being fully reversible within 72 h with a mean score of 0.8 over 24, 48 and 72 h out of all animals. No further local or systemic effects were reported.

In summary, ethylene distearate is not eye irritating.

 

CAS 68583-51-7

Several studies investigating the eye irritation properties of Decanoic acid mixed diesters with octanoic acid and propylene glycol are available.

The eye irritation properties of Decanoic acid, mixed diesters with octanoic acid and propylene glycol were tested in a study according to OECD guideline 405 in compliance with GLP (Henkel, 1988).

In a group of 4 male rabbits (Kleinrusse), 0.1 mL of the undiluted test substance was applied into one eye, in a single application without washing. The eyes were observed and reactions were evaluated 1, 6, 24, 48 and 72 h after application. No effects on corneal opacity and iris were noted at any time point in any animal. However, mild conjunctival redness was observed in 2/4 animals at the 1 h reading time point. In one of these animals the effect was fully reversible within 6 h; in the second animal mild redness was apparent until 6 h after application being fully reversible after 24 h as well (mean score over 24, 48 and 72 h out of all 4 animals = 0). No chemosis or exudation were observed during the study period in any animal.No further local or systemic effects were observed in any animal during the study period.

Three further studies are available, in which the eye irritating properties of Decanoic acid, mixed diesters with octanoic acid and propylene glycol were studied in rabbits (Consultox Laboratories Ltd., 1976; Safepharm Laboratories, 1988 and 1989).

In each study, 0.1 mL of the undiluted test material was instilled in one single application into the eye of 3 or 6 rabbits. Reactions in the eyes were observed at 1, 24, 48 and 72 h (Guest 1988 and 1989) and additionally at Day 4 and Day 7 after application (Consultox Laboratories Ltd., 1976).

In one study, the treated eyes of 2 groups with each 3 animals (washed eyes and unwashed eyes) were observed. In both groups, no effects on cornea, iris, chemosis and discharge were observed. In the group without washing, 1/3 animals showed slight redness and in 1/3 animals moderate erythema of the conjunctivae was observed, which were fully reversible within 48 h (Consultox Laboratories Ltd., 1976).

In both studies by Guest (1988 and 1989), no effects on cornea, iris, chemosis and discharge and no other local or systemic effects were apparent after 24, 48 and 72 h. In addition, no effects on conjunctivae were observed in the study by Guest, 1988. In the second study (Safepharm Laboratories, 1989), after 1 h, mild redness was observed in 1/3 animals and moderate redness in 2/3 animals. After 24 h minimal redness was observed in 3/3 animals and was fully reversible within 48 h in all animals with a mean score of 0.3 over 24, 48 and 72 h out of all 3 animals.

In summary, Decanoic acid, mixed diesters with octanoic acid and propylene glycol is not eye irritating.

 

CAS 84988-75-0

One study investigating the eye irritation properties of Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol is available.

In the study, Decanoic acid, mixed diesters with octanoic acid and propylene glycol were tested in a study according to OECD guideline 405 in compliance with GLP (Henkel, 1991).

In a group of 3 male rabbits (Kleinrusse), 0.1 mL of the undiluted test substance was applied into one eye, in a single application without washing. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h after application. No effects on cornea and iris were noted at any time point in any animal. However, slight erythema was observed in 2/3 animals at the 24 h reading time point being fully reversible within 48 h (mean score over 24, 48 and 72 h out of all 3 animals = 0.22). Slight chemosis was observed in 1 animal until the 24 h reading time point. No further local or systemic effects were observed in any animal during the study period.

In summary, Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol is not eye irritating.

 

CAS 624-03-3

No studies are available investigating the eye irritating properties of ethane-1,2-diyl palmitate.In order to fulfil the standard information requirements set out in Annex VII, 8.1, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 read-across from the structurally related category ethylene distearate (CAS 627-83-8) was conducted.

The available data from the category member ethylene distearate is described under the respective CAS number.

Based on the available data on eye irritation properties of the category member ethylene distearate, it was concluded, that there is no evidence of eye irritation properties of ethane-1,2-diyl palmitate.

 

Conclusion for eye irritation properties

In conclusion, the eye irritation properties of the Glycol Ester category members have been investigated in 11 in vivo studies indicating no eye irritation properties. Therefore, none of the category members of the Glycol Ester group is eye irritating.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the group concept is applied to the members of the Glycol Ester Category, data will be generated from representative reference substance(s) within the category to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labeled on this basis.

Therefore, based on the group concept, all available data on Irritation / Corrosion do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.