2-octyldodecyl myristate

Endpoint summary

Description of key information

Skin, rabbit: not irritating
Eye, rabbit: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 - 26 Jun 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. 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:

other: mean over 24, 48 and 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:

other: mean over 24, 48 and 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). Mean scores for intact skin only.

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 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:

other: mean over 24, 48 and 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). 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:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. 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:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

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

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

animal #4

Time point:

other: mean over 24, 48 and 72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

iris score

Basis:

animal #6

Time point:

other: mean over 24, 48 and 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:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 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:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

animal: #3, #5 and #6

Time point:

other: mean over 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

other: mean over 24, 48 and 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:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not irritating
DSD: not irritating

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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 (Masson, 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.

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 (Guillot, 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.

 

Overall conclusion for skin and eye irritation

The available data did not show any skin or eye irritation effects. Therefore, 2-octyldodecyl myristate is not considered to be a skin irritant or an eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.