[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin irritation/corrosion, rabbit (OECD 404): not irritating

Read-across from structural analogue source substance glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS 91744 -23 -9).

 

Eye irritation, rabbit (OECD 405): not irritating

Read-across from structural analogue source substance glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS 91744 -23 -9).

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:

experimental study

Adequacy of study:

supporting study

Study period:

9 Apr -17 Apr 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

lack of test material details

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of test material details

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 19-20 months
- Weight at study initiation: 2770 g
- Housing: animals were housed individually in cages (Heinkel, Kuchen, Germany)
- Diet: Altromin Haltungsdiät 2023 (Altromin GmbH, Lage, 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

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: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with gauze, held in place with an adhesive hypoallergenic tape.

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: 72 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:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

After 1h 2/3 animals showed slight erythema being reversible within 24h and 7 days, respectively. After 48 h 1/3 animals showed slight erythema being reversible after 72 h. Edema formation was apparent in 1/3 animals at the 48 and 72 h reading time point and was reversible within 7 days.

Table 1. Results of skin irritation study.

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	1	0	1	0
24 h	0	0	0	0	1	0
48 h	1	0	0	0	2	1
72 h	0	0	0	0	1	1
7 days	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.3	0.0	0.0	0.0	1.3	0.7

Interpretation of results:

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

Conclusions:

CLP: not classified

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-03-11 to 1996-03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, tested with the source substance glyceryl citrate/lactate/linoleate/oleate (CAS 91744-23-9). According to the ECHA guidance document ‘Practical guide 6: How to report read-across and categories' (ECHA, 2012), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: adult, no further details mentioned
- Weight at study initiation: 3 - 4.4 kg
- Housing: conventionally, singly in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K 4- Complete feed for rabbits, supplied by Ssniff, Soest, Germany, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- 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:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

14 days
Reading time points: 30 - 60 min, 24, 48 and 72 h, 6, 8, and 14 days after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: gauze patch covered with a non-irritant plaster and a semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD Guideline 404

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 1.67
- Edema: 1.11

Other effects:

The following effects were noted:
2-3 days: slightly oedema
day 8:light brown discoloration and dryness of skin.
day 10: subsided irritations

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
30 - 60 min	2/2/2	2/1/1
24 h	2/2/2	1/1/2
48 h	1/2/1	1/1/1
72 h	1/2/2	1/1/1
Average 24h, 48h, 72h	1.67	1.11
Reversibility*)	c.	c.
Average time (unit) for reversion	14 days	14 days

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:

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

Conclusions:

CLP: not classified

Executive summary:

Dermal irritation of the test substance (CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) was investigated in a study according to OECD 404 and GLP. 0.5 g of the test substance were applied to the shaved skin of three New Zealand White rabbits (semi-occlusive coverage). Total exposure was 4 h. Thereafter, the test substance was removed using warm water.

Observations were made after 30-60 minutes, 24, 48, and 72 h, as well as 6, 8, and 14 days after patch removal. An adjacent area of untreated skin served as control.

Mean erythema and edema scores after 24, 48, and 72 h were 1.67 and 1.11, respectively. Both were fully reversible within 14 days.

Based on the results of this test the substance is slightly irritating but does not warrant classification according to CLP.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

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

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to the analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Source CAS 91744-23-9

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Source CAS 91744-23-9

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Source CAS 91744-23-9

Irritation parameter:

edema score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Source CAS 91744-23-9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Source CAS 91744-23-9

In addition to the key study with source substance CAS 91744 -23 -9, data on skin irritation is also available for source substane CAS 91744 -13 -7. For the latter source substance, the mean erythema scores over 24/48/72 h in three animals were 0.3, 0.0 and 1.3 and mean edema scores over 24/48/72 h were 0.0, 0.0 and 0.7, respectively. All effects were fully reversible within 7 days.

The study with source substance CAS 91744 -23 -9 was selected as key study because of higher structural similarity with the target substance EC 701 -358 -7. In addition, the study period was more recent than for source substance CAS 91744 -13 -7.

Interpretation of results:

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

Conclusions:

As detailed in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin irritation potential. The available data on suitable source substances CAS 91744-13-7 and CAS 91744-23-9 did not show any skin irritation effects. Therefore, the target substance is not predicted to be a skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

7 May - 10 May 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

lack of test material details

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of test material details

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: 21-24 months
- Weight at study initiation: 2560 g
- Housing: animals were housed individually in cages (Heinkel, Kuchen, Germany)
- Diet: Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, 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:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 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

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with lukewarm water
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

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, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

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:

No corneal opacity, iritis, conjunctivae or chemosis were observed in any animal at any reading time point. All animals showed slight to moderate exudation exclusively at the 1 h reading time point.

Other effects:

No further local or system effects were reported.

Interpretation of results:

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

Conclusions:

CLP: not classified

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-03-18 to 1996-03-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

GLP guideline study, tested with the source substance glyceryl citrate/lactate/linoleate/oleate (CAS 91744-23-9). According to the ECHA guidance document ‘Practical guide 6: How to report read-across and categories' (ECHA, 2012), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adult, no further details mentioned
- Weight at study initiation: 2.8 - 3.8 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 - Complete feed for rabbits, supplied by Ssniff, Spezialfutter GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- 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 cm³

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after administration

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 24 hours after administration

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, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

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:

AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0

Other effects:

marked hyperaemias of some blood vessels in all animals one hour after application, after 24 hours no effects was noticed.

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	0/0/0
24 h	0/0/0	0/0/0	0/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0	0
Area effected	-	-	-	-
Maximum average score (including area affected, max 110)	0	0	0	0
Reversibility*)	-	-	-	-
Average time (unit) for reversion	-	-	-	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:

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

Conclusions:

CLP: not classified

Executive summary:

Eye irritation of the test substance (CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) was investigated in a study according to OECD 405 and GLP. 0.1 cm³ of the test substance were instilled in one eye each of the three New Zealand White rabbits. Total exposure was 24 h. Thereafter, the test substance was removed using warm physiological saline.

Observations were made after 1, 24, 48, and 72 h after administration. The untreated eye of each animal served as control.

Marked hyperaemias of some blood vessels could be observed in all animals 1 h after application, after 24 hours no effects was noticed. Mean scores for cornea, iris, conjunctivae redness and conjunctivae chemosis after 24, 48, and 72 h were 0 for each endpoint.

Based on the results of this test the substance is classified as not irritating.

Reference 3

Endpoint:

eye irritation: in vivo

Type of information:

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

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to the analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

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

Remarks on result:

other: Source CAS 91744-23-9

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

Remarks on result:

other: Source CAS 91744-23-9

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Remarks on result:

other: Source CAS 91744-23-9

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

Remarks on result:

other: Source CAS 91744-23-9

In addition to the key study with source substance CAS 91744 -23 -9, data on eye irritation/corrosion is also available for source substance CAS 91744 -13 -7. For the latter source substance, the mean scores on corneal opacity, iritis, conjunctival redness and chemosis were over 24/48/72 h were 0 for all animals.

The study with source substance CAS 91744 -23 -9 was selected as key study because of higher structural similarity with the target substance EC 701 -358 -7. In addition, the study period was more recent than for source substance CAS 91744 -13 -7.

Interpretation of results:

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

Conclusions:

As detailed in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in eye irritation potential. The available data on suitable source substances CAS 91744-13-7 and CAS 91744-23-9 did not show any eye irritation effects. Therefore, the target substance is not predicted to be an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for read-across

There are no data on skin and eye irritation/corrosion available for glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7). The assessment of irritation and corrosion was therefore based on studies conducted with analogue substances as part of a read across approach, in order to fulfil the standard requirements set out in Annex VII, 8.1 and 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. For skin and eye irritation/corrosion, read-across was conducted with the structurally related analogue substances glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS 91744-13-7) and glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS 91744 -23 -9). A statement on the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

 

Skin irritation

CAS 91744-23-9

The dermal irritation potential of glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts was investigated in a study according to OECD 404 and GLP (Sasol, 1996c). 0.5 g of the test substance was applied to the shaved skin of three New Zealand White rabbits (semi-occlusive coverage). Total exposure was 4 h. Thereafter, the test substance was removed using warm water. Observations were made after 30-60 minutes, 24, 48, and 72 h, and 6, 8, and 14 days after patch removal. An adjacent area of untreated skin served as control. Mean erythema and edema scores over the 24, 48, and 72 h reading time points were 1.33/2/1.67 and 1/1/1.33 for the three animals, respectively. All effects were fully reversible within 14 days. Based on the results of this test the substance is slightly irritating but does not warrant classification according to CLP.

CAS 91744-13-7

The skin irritation potential of glycerides, C14-18 and C16-22-unsatd, mono- and di- was investigated in a GLP-conform study performed according to OECD guideline 404 (BASF, 1990a). 0.5 mL of the test substance was applied for 4 h to the shaved skin of 3 Kleinrussen, Chbb:HM rabbits under semi-occlusive conditions. The untreated site of the animals served as control. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h, and 7 days after removal of the dressing. In one animal, slight erythema persisted up to the 72 h, but was fully reversible within the 7-day observation period. In the two other animals, slight erythema was seen at the 1 or 48 h reading, respectively, but was fully reversible 24 h or 72 h after patch removal. Slight edema was only noted in one animal at both the 48 and 72 h reading time points, but fully reversed during the 7-day observation period. No signs of systemic toxicity were seen during the study. The mean erythema and edema scores over the 24, 48 and 72 h reading time points were 0.3/0/1.3 and 0/0/0.7 for the 3 animals. Thus, the test substance is considered to be non-irritating to the skin.

 

Eye irritation

CAS 91744-23-9

The eye irritation potential of glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts was investigated in a study according to OECD 405 and GLP (Sasol, 1996d). 0.1 cm³ of the test substance were instilled in one eye each of the three New Zealand White rabbits. Total exposure was 24 h. Thereafter, the test substance was removed using warm physiological saline. Observations were made after 1, 24, 48, and 72 h after administration. The untreated eye of each animal served as control. Marked hyperaemias of some blood vessels could be observed in all animals 1 h after application, after 24 hours no effects was noticed. Mean scores for cornea, iris, conjunctivae redness and conjunctivae chemosis after 24, 48, and 72 h were 0 for all animals. Based on the results of this test the substance is considered not irritating to the eye.

CAS 91744-13-7

The eye irritation potential of glycerides, C14-18 and C16-22-unsatd, mono- and di- was investigated according to OECD guideline 405 and in compliance with GLP (BASF, 1990b). The undiluted test material (0.1 mL) was placed into the conjunctival sac of one eye of 3 male Kleinrussen (Chbb:HM) rabbits each. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. No corneal opacity, iritis, conjunctivae or chemosis were observed in any animal at any reading time point. All animals showed slight to moderate exudation exclusively at the 1 h reading time point. No further local or systemic toxic effects were reported. The mean cornea, iris, conjunctivae and chemosis scores after 24, 48, and 72 h were 0 for all 3 animals, respectively. Thus, the test substance was not considered as eye irritant.

 

Overall conclusion for skin and eye irritation

The reliable data available for the read-across analogue substances glycerides, C14-18 and C16-22-unsatd, mono- and di- (CAS No. 91744-13-7) and glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS No. 91744 -23 -9) did not show any skin or eye irritation effects. Therefore, glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7) is not expected to be a skin irritant or an eye irritant.

Justification for classification or non-classification

Based on read-across from structurally similar substances, the available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.