[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating

Read across from source substances 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) and glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS 91744-13-7)

 Eye irritation (OECD 405) not irritating

Read across from source substances 1,2,3-propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) and 9-octadecenoic acid (Z), diester with oxybis[propanediol]) (CAS 67965-56-4)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Lack of data on test substance. Lack of data on test material. Occlusive conditions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack of data on test material. Occlusive conditions.

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrusse, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.3 kg
- Housing: The animals were single housed in rabbit cages.
- Diet: 20 ZH 5, Nohrlin GmbH
- Water: tap water, ad libitum
- Acclimation period: at least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 50
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

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:

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

Number of animals:

4 males

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with a plastic film, held in place with adhesive plasters and acrylastic tape.

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal: mean out of all 4 animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

edema score

Basis:

animal: mean out of all 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The dermal application of the test substance did not result in edema in any of the animals tested at any observation time point. Very slight to slight erythema formation was observed in 3/4 animals at the 24 and 48 h reading time points. At the 72 h reading time point, slight and moderate erythema formation was observed in 2/4 animals. The effects were reversible in all animals within 7 d after the application of the test substance.

Table 1. Results of skin irritation study

Observation time	Rabbit no.
	1		2		3		4
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	1	0	0	0	1	0
24 h	0	0	1	0	1	0	2	0
48 h	0	0	1	0	1	0	2	0
72 h	0	0	0	0	1	0	3	0
7 d	0	0	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.00	0.00	0.67	0.00	1.00	0.00	2.33	0.00
Mean value 24 + 48 + 72 h all animals	1.00	0.00

Interpretation of results:

not irritating

Conclusions:

CLP: not classified
DSD: not classified

Reference 3

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:

other: GLP - Guideline study. 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:

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

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

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

animal #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:

not irritating

Conclusions:

CLP: not classified
DSD: not classified

Reference 4

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 assesssment 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:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Remarks on result:

other:

Remarks:

CAS 63705-03-3

Irritation parameter:

edema score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 63705-03-3

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

Remarks on result:

other:

Remarks:

CAS 91744-13-7

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 91744-13-7

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

Remarks on result:

other:

Remarks:

CAS 91744-13-7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 91744-13-7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 91744-13-7

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

Remarks on result:

other:

Remarks:

reversibility: not applicable

Interpretation of results:

not irritating

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 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 vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Justification for type of information:

To cover eye irritation for the substance, read-across is performed with Triglycerindiisostearat and with 9-Octadecanoic acid (Z), diester with oxybis[propanediol]. For Triglycerindiisostearat, an in vivo study was performed in 1988. For 9-Octadecanoic acid (Z), diester with oxybis[propanediol], Scheel et al published in 2011 a study comparing results of the in vivo eye irritation study with the HET-CAM method. This publicly available information was included in IUCLID.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Lack of data on test substance.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack of data on test substance.

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrusse, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.5 kg
- Housing: The animals were single housed in rabbit cages.
- Diet: Altromin 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- 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:

single application without washing

Observation period (in vivo):

3 d
Reading time points: 1, 6, 24, 48 and 72 h

Number of animals or in vitro replicates:

4 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal: mean out of all 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

animal: mean out of all 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal: mean out of all 4 animals

Time point:

24/48/72 h

Score:

0.08

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal: mean out of all 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/4 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance.

Interpretation of results:

not irritating

Conclusions:

CLP: not classified
DSD: not classified

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Principles of method if other than guideline:

The HET-CAM was used to measure irritation potential of chemicals following the protocol published in the 1990s by the cosmetic industry (Brantom et al., 1997, Toxicology In Vitro, 11, 141-179; Steiling et al., 1999, Toxicology In Vitro, 13, 375-384; Sterzel et al., 1990, Toxicology In Vitro, 4, 698-701) and was evaluated in a number of studies including the European COLIPA validation study (Brantom et al., 1997, Toxicology In Vitro, 11, 141-179). The results were obtained either using the Reaction Time Method (RT) (Steiling et al., 1999, Toxicology In vitro, 13, 375-384).

GLP compliance:

yes

Species:

other: in vitro

Strain:

other: chicken eggs

Vehicle:

unchanged (no vehicle)

Controls:

other: internal standard (5% aqueous solution of sodium magnesium lauryl-myristyl-6-ethoxysulfate) with well-known irritating potential was used as benchmark for categorization of irritation potential

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 µL or sufficient amount to cover at least 25% of the CAM
- Concentration (if solution): 100%

Duration of treatment / exposure:

300 seconds

Observation period (in vivo):

300 seconds

Number of animals or in vitro replicates:

2 eggs in pretest and 6 eggs in main test

Details on study design:

SCORING SYSTEM:
Effects: occurrence of specific effects on the CAM and/or its blood vessels, H - Hemorrhage, L - Lysis, C - intravasal and/or extravasal coaggulation
RT scores - individual time of occurrence of effects were recorded during a maximum observation period of 300 seconds, a test item specific irritation score was determined by equal valuation of individual effects without using ranking factors. The benchmark chemical was tested in parallel and both irritation scores (mean over all eggs) were used to calculate the Q-value (quotient of both scores). This Q-value is the relevant parameter for prediction of irritancy classes (see table 1 under "Any other information on material and methods including tables").

Irritation parameter:

other: Q-score

Run / experiment:

mean of all 6 eggs

Value:

1.2

Vehicle controls validity:

not valid

Negative controls validity:

not valid

Positive controls validity:

not valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

no details given

Interpretation of results:

not irritating

Conclusions:

DSD: not classified
CLP: not classified

Reference 4

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified

SCORING SYSTEM: Draize Scoring System

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal#1 - animal#3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal#1 - animal#3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal#1 - animal#3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal#1 - animal#3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

no effects were observed in all animals tested

Other effects:

no other effects observed

Interpretation of results:

not irritating

Conclusions:

DSD: not classified
CLP: not classified

Reference 5

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 63705-03-3

Irritation parameter:

iris score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 63705-03-3

Irritation parameter:

conjunctivae score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.08

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other:

Remarks:

CAS 63705-03-3

Irritation parameter:

chemosis score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 63705-03-3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

mean out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 67965-56-4

Irritation parameter:

iris score

Basis:

mean

Remarks:

mean out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 67965-56-4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

mean out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Remarks on result:

other:

Remarks:

CAS 67965-56-4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

mean out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other:

Remarks:

CAS 67965-56-4

Interpretation of results:

not irritating

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 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

There are no skin and eye irritation/corrosion data available on Fatty acids, C16-18 (even numbered), esters with glycerol oligomers. Skin and eye irritation studies with the registered substance have been commissioned at a CRO. Therefore, as an interim measure, the skin and eye irritation potential of the registered substance was assessed based on the available data from the source substances 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS 91744-13-7) and 9-octadecenoic acid (Z), diester with oxybis[propanediol]) (CAS 67965-56-4). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from analogue substances have been applied to support the human health hazard assessment of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers.

 

Skin irritation

 

CAS 63705-03-3

 

The skin irritation potential of 1,2,3-propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) was investigated according to OECD Guideline 404 and GLP (Kaestner, 1998). The shaved dorsal area of the trunk of three male Kleinrussen rabbits was exposed to unchanged test material for 4 hours. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48, 72 hours and 7 days after removal of the test substance. The dermal application of the test substance did not result in edema in any of the animals tested at any observation time point. Very slight to slight erythema was observed in 3/3 animals at the 24 and 48 h reading time points. At the 72 h reading time point, slight and moderate erythema was observed in 2/3 animals. The effects were reversible in all animals within 7 days after the application of the test substance. The slight irritating effects seen in skin are below the hazard classification limit and therefore the substance is assumed as not irritating to skin.

 

 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 (Steiling, 1990). 0.5 mL of the test substance was applied for 4 h to the shaved skin of 3 Kleinrussen, Chbb:HM rabbits under semiocclusive conditions. The untreated site of the animals served as control. The scoring of skin reactions (erythema and edema) was performed according to Draize at 1, 24, 48, 72 h as well as 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 either seen at the 1 or 48 h reading, 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 63705 -03 -3

 

An acute eye irritation study was performed with 1,2,3-propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) according to OECD Guideline 405 and GLP (Kaestner, 1988).

0.1 mL of test substance was instilled in the conjuctival sac of one eye of each of 3 Kleinrussen rabbits. The animals were observed over 3 days. Eye irritation was scored by mean of the Draize scoring system at the following reading time points: 1, 6, 24, 48 and 72 h. The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/3 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance. As the slight irritating effects are below the hazard classification limit, the substance is assumed as not irritating to the eye.

Under the experimental conditions described, it was concluded, that no evidence of eye irritation properties was seen in rabbit after treatment with 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CA 63705-03-3).

 

CAS 67965-56-4

 

For this source substance, in vitro and in vivo data are available with respect to eye irritation.

The HET-CAM was used to measure irritation potential of chemicals following the protocol published in the 1990s by the cosmetic industry (Brantom et al., 1997, Toxicology In Vitro, 11, 141-179; Steiling et al., 1999, Toxicology In Vitro, 13, 375-384; Sterzel et al., 1990, Toxicology In Vitro, 4, 698-701) and was evaluated in a number of studies including the European COLIPA validation study (Brantom et al., 1997, Toxicology In Vitro, 11, 141-179). The results were obtained using the Reaction Time Method (RT) (Steiling et al., 1999, Toxicology In vitro, 13, 375-384). 9-octadecenoic acid (Z), diester with oxybis[propanediol]) (CAS 67965-56-4) was found to be not irritating in both in vitro (HET-CAM) and in vivo studies (Scheel, J et, al., 2011).

 

Conclusions

Based on the available data, none of the two source substances considered - 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) and glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS 91744-13-7) - was found to be a skin irritant. Thus and based on read-across, it can be concluded that the registration substance is not a skin irritant. 

Results of an eye irritation study conducted with both source substances 1, 2,3-propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) and 9-octadecenoic acid (Z), diester with oxybis[propanediol]) (CAS 67965-56-4) did not provide any evidence of eye irritation properties. Thus and based on read-across, it can be concluded that the registration substance is not 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/corrosion do not meet the classification criteria according to Regulation (EC) No. 1272/2008 (CLP), and are therefore conclusive but not sufficient for classification.