Fatty acids, C18-unsaturated, 2-hexyldecyl ester

Endpoint summary

Description of key information

Skin, rabbit (OECD 404): not irritating

Eye, rabbit (OECD 405): not irritating

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:

weight of evidence

Study period:

23 - 26 Jun 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The test substance was applied under occlusive conditions for 24 h, no experimental 48 h reading was performed, the analytical purity was not reported.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted Apr 2002

Deviations:

yes

Remarks:

exposure period 24 h, occlusive conditions, no experimental 48 h reading performed, analytical purity not reported

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

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

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

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:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal: #1, #5 and #6

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). Mean scores for intact skin only.

Irritation parameter:

erythema score

Basis:

animal: #2 and #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: 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). Mean scores for intact skin only.

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not 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). Mean scores for intact skin only.

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: 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). Mean scores for intact skin only.

Irritant / corrosive response data:

Intact skin:
1/6 animals had slight erythema (score 1) at the 24-hour and 72-hour reading time points, while 3/6 rabbits had slight erythema at the 24-hour reading time point only (see Table 1). No edema was observed in any animals at any time point.

Abraded skin:
1/6 animals had slight erythema (score 1) at the 24-hour and 72-hour reading time point, while 4/6 rabbits had slight eythema at the 24-hour reading time point only (see Table 1). No edema was observed in any animals at any time point.

Table 1: Individual erythema and edema scores for intact skin

	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	1	0	0	0	1	0	1	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	1	0	0	0	0	0	0	0

 

Table 2: Calculation of mean scores for intact skin

	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	0	0	1.00	0	0	0	0.67	0	0.67	0

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:

experimental study

Adequacy of study:

weight of evidence

Study period:

April 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Data on analytical purity, animal husbandry and the dose applied are missing.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

yes

Remarks:

data on analytical purity, animal husbandry and dose applied are missing

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

other: untreated sites of the same animal served as control

Duration of treatment / exposure:

4 h

Observation period:

5 days
Reading time points: 1, 24, 48 and 72 h, and 5 days

Number of animals:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritant / corrosive response data:

3/3 animals had very slight erythema (grade 1) 1 hour after exposure ended. Very slight oedema (grade 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point, while 2/3 did not have edema at any reading time point. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well defined erythema. The erythema cleared in 1/3 animals within 48 hours and in the remaining 2 within 5 days. All irritation reactions were completely reversible within 5 days.

Table 1: Erythema and edema scores for the individual animals

Animal No.	Reading time point	Erythema score	Edema score
1	1 h	1	0
	24 h	1	0
	48 h	1	0
	72 h	1	0
	5 d	0	0
2	1 h	1	0
	24 h	1	0
	48 h	0	0
	72 h	0	0
	5 d	0	0
3	1 h	1	1
	24 h	2	1
	48 h	1	1
	72 h	1	1
	5 d	0	0

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:

experimental study

Adequacy of study:

weight of evidence

Study period:

26 -29 May 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The analytical purity of the test substance was not specified.

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: 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: ESD (Chatillon sur Chalaronne, France)
- Weight at study initiation: 2-2.5 kg
- Housing: animals were housed individually in stainless steel cages with a wiremesh floor
- Diet: Food ref. 110-10 (U.A.R., Epinay sur Orge, France), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-80
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26 May 1999 To: 29 May 1999

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:

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

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: a gauze patch covering the test site was held in place by micropore tape; the trunk of the animals was wrapped in an elastic gauze band and semiocclusive, adhesive tape. Access to the test site was restricted with a plastified aerated wrapping fixed to the trunk of the animals with velcro tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remnants of the test substance were removed with distilled water or, if necessary, a suitable solvent
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No skin irritation effects were observed at any time point in any animal.

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

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The analytical purity of the test substance was not reported.

Qualifier:

according to guideline

Guideline:

other: Journal Officiel, 21.04.1971, amended on 05.06.1973

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Oct 2012

Deviations:

yes

Remarks:

analytical purity not reported

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: the animals are housed individually in polystyrene cages (540 mm x 360 mm x 315 mm) with a perforated polystyrene floor
- Diet: 150 g complete maintenance food, granulés lapin Entretien '117' (UAR, Villemasson/Orgel, France)
- Water: softened and filtered drinking water, ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): minimum 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

Single instillation without rinsing

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h, and 4 and 7 days

Number of animals or in vitro replicates:

6 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: opthalmoscope; supplemetary assessments are performed using a hand-slit lamp, if necessary

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

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

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

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

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: 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:

chemosis score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal: #3, #5 and #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

At the 1-h reading time point 6/6 rabbits had slight to moderate conjunctivae and chemosis (score 1 – 2), and effects on the iris (score 1). At the 24-h reading time point, slight conjunctivae (score 1) was observed in 1/6 rabbits, and slight chemosis (score 1) was seen in 4/6 other rabbits. Chemosis (score 1) was still present in 1/6 rabbits 48 h after instillation. Iris effects were observed in 2/6 animals at the 24-h reading time point, persisting in 1/6 until 48 h after instillation. All eye irritation effects had cleared completely within 72 h. No cornea opacity was observed in any rabbit at any time point (see Table 1).

Table 1. Individual eye irritation scores

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	1	1	1	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0
2	1 h	1	2	1	0
	24 h	1	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.33	0.0	0.0	0.0
3	1 h	2	2	1	0
	24 h	0	1	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.33	0.0	0.0
4	1 h	2	2	1	0
	24 h	0	1	1	0
	48 h	0	0	1	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.33	0.67	0.0
5	1 h	2	2	1	0
	24 h	0	1	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.33	0.0	0.0
6	1 h	1	2	1	0
	24 h	0	1	1	0
	48 h	0	1	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.67	0.33	0.0

*(24h+48h+72h)/3

Interpretation of results:

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

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

23 - 26 Feb 1998

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:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: 8 weeks
- Weight at study initiation: 1.49-1.58 kg
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, the Netherlands), approximately 100 g/day. Hay (BMI, Helmond, the Netherlands) was provided once a week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 Feb 1998 To: 26 Feb 1998

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):

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 (if done): the eye was not washed after application

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: during the 24-hour reading time point, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal and the extent of corneal epithelial damage was assessed using a UV-light.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

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:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

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:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point (see Table 1).

Other effects:

There was no mortality, and no clinical signs were observed during the study period.

Table 1: Eye irritation scores

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	1 (AB)	0	0	0
	24	1 (A)	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.0	0.0	0.0
2	1	1 (ABC)	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.00	0.0	0.0	0.0
3	1	1 (AB)	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.00	0.0	0.0	0.0

 

	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	1.00	0.00	0.00	0.00
	24	0.33	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	0.11	0.00	0.00	0.00

A = eyelids

B = nictating membrane

C = sclera

Interpretation of results:

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

Reference 3

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

26 - 31 May 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The analytical purity of the test substance was not specified.

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:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ESD (Chatillon sur Chalaronne, France)
- Weight at study initiation: 2-2.5 kg
- Housing: animals were housed individually in high impact polystyrene cages with a mesh floor
- Diet: Food ref. 112 (U.A.R., Epinay sur Orge, France)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-80
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26 May 1999 To: 31 May 1999

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):

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

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: After instilling 2% fluorescein into the eyes, any damage was assessed with a UV-lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

At the 1-hour reading time point, 3/3 rabbits had slight-moderate conjunctivae (scores 1, 1, 2) and 2/3 slight chemosis (scores 0, 1, 1). The chemosis had cleared by the 24-hour reading time point, while 3/3 animals still had slight conjunctivae (scores 1, 1, 1). All eye irritation effects were fully reversible within 48 hours.

Table 1: Eye irritation score

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	1	0	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0.0	0.0	0.0
2	1	2	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	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	0.33	0.0	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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Analogue justification

No data on skin and eye irritation of Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6) are available. The assessment of skin and eye irritation was therefore based on studies conducted with source substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. 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. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Skin irritation

CAS 22766-83-2

A skin irritation study was performed with 2-octyldodecyl myristate (CAS 22766-83-2), according to a protocol similar to OECD guideline 404 (WoE, 1986). 0.5 mL of the test substance was applied to the shaved and abraded skin of 6 male rabbits and held in place by an occlusive dressing for 24 hours. The skin irritation effects were scored 24 and 72 hours after patch removal. At the intact skin site 1/6 animals had slight erythema (score 1) at the 24-hour and 72-hour reading time points, while 3/6 rabbits had slight erythema at the 24-hour reading time point only. No edema was observed in any animals at any time point. The results of the abraded skin sites were comparable to the results of the intact skin sites after test substance application, but were not taken into account for hazard assessment. There was no 48-hour reading time point. To be able to calculate the mean scores, the 48-hour scores were assumed to be the same as those determined 24 hours after patch removal (worst case assumption). The mean erythema scores (over 24, 48 and 72 hours) were 0.67, 0, 1, 0, 0.67 and 0.67 while all the mean edema scores (over 24, 48 and 72 hours) were 0. The test substance is not considered to be irritating to the skin.

CAS 3687-46-5

In a reliable study decyl oleate (CAS No. 3687-46-5) was tested for its skin irritation potential according to OECD guideline 404 (WoE, 1994). The shaved skin of three male rabbits was exposed to an unknown volume of the test material for 4 hours under semi-occlusive conditions. The rabbits were observed for 5 days. Skin reactions were assessed according to Directive 67/548/CEE approximately 1, 24, 48 and 72 hours, and 5 days after removal of the test substance. 3/3 animals had very slight erythema (grade 1) 1 hour after exposure ended. Very slight oedema (grade 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point, while 2/3 did not have edema at any reading time point. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well defined erythema. The erythema cleared in 1/3 animals within 48 hours and in the remaining 2 within 5 days. All irritation reactions were completely reversible within 5 days. The mean erythema scores (over 24, 48 and 72 hours) were 1.0, 0.33 and 1.33, respectively; while the mean edema scores (over 24, 48 and 72 hours) were 0, zero and 1.0, respectively. The test substance is not considered to be irritating to the skin.

CAS 72576-80-8

A skin irritation study was performed with hexadecanoic acid isooctadecyl ester (CAS 72576-80-8), according to OECD guideline 404 and under GLP conditions (WoE, 1999). 0.5 mL of the test substance was applied to the shaved skin of 3 New Zealand White rabbits and held in place by a semi-occlusive dressing for 4 hours. The severity of erythema and edema was scored 1, 24, 48 and 72 hours after patch removal. No skin irritation was observed at any time point in any animal; all erythema and edema scores were 0. The test substance is not considered to be irritating to the skin.

Eye irritation

CAS 22766-83-2

An eye irritation study was performed with 2-octyldodecyl myristate (CAS 22766-83-2) according to the guideline published in ‘Journal Officiel, 21.04.1971, amended on 05.06.1973’, which is similar to OECD guideline 405 (WoE, 1982). 0.1 mL of the test substance was instilled into the eyes of 6 male New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours, and 4 and 7 days after application. The eyes were not rinsed. At the 1-hour reading time point 6/6 rabbits had slight to moderate conjunctivae and chemosis (score 1 – 2), and effects on the iris (score 1). At the 24-hour reading time point, slight conjunctivae (score 1) was observed in 1/6 rabbits, and slight chemosis (score 1) was seen in 4/6 other rabbits. Chemosis (score 1) was still present in 1/6 rabbits 48 hours after instillation. Iris effects were observed in 2/6 animals at the 24-hour reading time point, persisting in 1/6 until 48 hours after instillation. All eye irritation effects had cleared completely within 72 hours. No cornea opacity was observed in any rabbit at any time point. The mean cornea score (over 24, 48 and 72 hours) was 0, while the mean iris score was 0, 0, 0, 0.67, 0 and 0.33. The mean conjunctivae score (over 24, 48 and 72 hours) was 0, 0.33, 0, 0, 0, and 0. The mean chemosis score (over 24, 48 and 72 hours) was 0, 0, 0.33, 0.67, 0.33 and 0.33. Based on the results of the study, the test substance is not considered irritating to the eyes.

 

CAS 93803-87-3

The eye irritation potential of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was evaluated in a study performed according to OECD guideline 405 (WoE, 1998). 0.1 mL was instilled into one eye of 3 rabbits and left without washing. Remains of the test substance were noted in the treated eye of 3/3 animals on Day 1, while remains were present on the outside of the eyelids on Day 2 in 1/3 animals. At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point.

CAS 72576-80-8

The eye irritation potential of hexadecanoic acid, isooctadecyl ester (CAS 72576-80-8) was evaluated in a study performed according to OECD guideline 405 and in compliance with GLP (WoE, 1999). 0.1 mL test substance was instilled into one eye of 3 male rabbits, and the eyes remained unwashed. The eye irritation effects were scored according to the Draize scoring system 1, 24, 48, and 72 hours, and 7 days after application. At the 1-hour reading time point, 3/3 rabbits had slight-moderate conjunctivae (scores 1, 1, 2), and 2/3 had slight chemosis (score 1). The chemosis had cleared by the 24-hour reading time point; while 3/3 animals still had slight conjunctivae (score 1). All eye irritation effects were fully reversible within 48 hours. No cornea opacity or iris changes were observed in any rabbit at any time point. The mean conjunctivae score (over 24, 48 and 72 hours) was 0.33, 0.33 and 0.33, while the mean chemosis score (over 24, 48 and 72 hours) was 0, 0 and 0. The mean cornea score and iris score (over 24, 48 and 72 hours) was 0 for all animals. Based on the results of the study, the test substance is not considered to be irritating to the eyes.

 

Overall conclusion for skin and eye irritation

The available data on suitable source substances did not show any skin or eye irritation effects. Therefore, the target substance Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6) is not expected to be a skin irritant or an eye irritant.

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 analogue concept is applied to Fatty acids, C18-unsaturated, 2-hexyldecyl ester (old CAS 94278-07-6), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

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.