2-octyldodecan-1-ol

Endpoint summary

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:

October until November 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: - missing test substance characterisation

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: Hazardous Substances, Part. 191, section 11, FDA, Washington 1965

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: laboratory breed
- Age at study initiation: not mentioned
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Altromin 2023, ad libitum, supplied by Altromin GmbH, Lage, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 60 ± 3
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

open

Preparation of test site:

other: abraded and shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 and 2 ml per kg bw was applied undiluted with softly brush

Duration of treatment / exposure:

24 hours

Observation period:

0, 5, 15, 30 min, 1, 2, 4, 24, 48, 72, 96, 120, 144 and 168 h after application

Number of animals:

36, two groups with intact and scarified skin, 3 female and male animals per group

Details on study design:

TEST SITE
- Area of exposure: 15*16 cm of shaved skin of the dorsal and lateral parts of the trunk of the animals
- coverage: approx. 10%
- Type of wrap if used: not used

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

SCORING SYSTEM: according to Draize-Scheme (0-4)
Examination time points: Signs of erythema and oedema (skin-thickness in mm) were recorded.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.22

Reversibility:

fully reversible

Remarks on result:

other: 2 ml/kg bw, scarified skin

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.22

Reversibility:

fully reversible

Remarks on result:

other: 2 ml/kg, intact skin

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Reversibility:

fully reversible

Remarks on result:

other: 1 ml/kg bw, scarified skin

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 nad 72 hours

Score:

1

Reversibility:

fully reversible

Remarks on result:

other: 1 ml/kg, intact skin

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema:
control group, scarified = 0, intact = 0;
2 ml test substance, scarified = 1.22, intact = 1.22;
1 ml test substance, scarified = 1, intact = 1.
- Edema:
control group, scarified = 3.67 mm, intact = 3.63 mm;
2 ml test substance, scarified = 3.93 mm, intact = 3.87 mm;
1 ml test substance, scarified = 3.77 mm, intact = 3.73 mm.
REVERSIBILITY: yes

Other effects:

none

Table 1: Irritant/corrosive response data (mean values)

Score at time point Reversibility	2 ml/kg bw		1 ml/kg bw		control group
	Erythema intact / scarified	Edema (mm) intact / scarified	Erythema intact / scarified	Edema (mm)intact / scarified	Erythema intact / scarified	Edema (mm)intact / scarified
0 min	0 / 0	3.6 / 3.6	0 / 0	3.7 / 3.6	0 / 0	3.6 / 3.6
5 min	0.2 / 0.2	3.7 / 3.8*	0.3 / 0.3	3.7 / 3.7	0 / 0.2	3.6 / 3.6
15 min	0.7 / 0.5	3.7 / 3.8*	0.8 / 0.8	3.8* / 3.7	0 / 0.2	3.6 / 3.6
30 min	1.2 / 1.0	3.8 / 3.9*	1.2 / 1.2	3.7 / 3.7	0 / 0	3.6 / 3.6
1 h	1.2 / 1.2	3.9* / 3.9	1.5 / 1.3	3.8* / 3.7	0 / 0	3.6 / 3.7
2 h	1.3 / 1.3	3.8 / 4.0*	1.3 / 1.7	3.8* / 3.7	0.2 / 0	3.6 / 3.6
4 h	1.5 / 1.7	3.9* / 4.0*	1.7 / 1.8	3.7 / 3.8	0.2 / 0	3.6 / 3.7
1 d	1.7 / 1.5	4.0* / 4.1*	1.7 / 1.5	3.8 / 3.7	0 / 0	3.7 / 3.7
2 d	1.0 / 1.2	3.8 / 3.9*	1.0 / 1.2	3.7 / 3.8*	0 / 0	3.6 / 3.6
3 d	1.0 / 1.0	3.8 / 3.8	1.0 / 1.0	3.7 / 3.8	0 / 0	3.6 / 3.7
4 d	0.7 / 1.0	3.8 / 3.8*	0.8 / 0.7	3.7 / 3.7	0.2 / 0	3.8 / 3.6
5 d	0.2 / 0.3	3.7 / 3.8*	0.2 / 0.5	3.8 / 3.7	0 / 0	3.7 / 3.6
6 d	0.2 / 0.2	3.8 / 3.7	0 / 0.2	3.7 / 3.7	0 / 0	3.7 / 3.6
7 d	0 / 0	3.6 / 3.7	0 / 0	3.7 / 3.7	0 / 0	3.7 7 3.7
Reversibility	c.	c.	c.	c.	c.	c.

 

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

* = signficanctly difference to control group p ¿ 0.01

 

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, 2-octyldodecan-1-ol is slightly irritating to the skin.

Executive summary:

Based on the results of this study, 2-octyldodecan-1-ol is slightly irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: - missing test substance characterisation

Qualifier:

according to guideline

Guideline:

other: Hazardous Substances, Part. 191, section 12, FDA, Washington 1965

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: laboratory breed
- Age at study initiation: not mentioned
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Altromin 2023, ad libitum, supplied by Altromin GmbH, Lage, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 60 ± 3
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: treatment of the second eye with 0.9 % NaCl solution

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml

Duration of treatment / exposure:

single administration, in each animal the test article was introduced into the conjunctival sac of the left eyes, afterwards the eyelid was closed for 1 second. Unlimited exposure (not rinsed).

Observation period (in vivo):

4 days (oberservations after 5, 15, 30 min, 1, 2, 4 h, 1, 2, 3 and 4 d)

Number of animals or in vitro replicates:

6 (3 male and 3 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize-Scheme (0-4)

TOOL USED TO ASSESS SCORE: slit lamp; treatment with Na-fluorescein, USP 24 hours after administration

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.33
- Conjuntivae (Chemosis): 0.0
DESCRIPTION OF LESIONS: In the area of the conjunctiva observed a slight erythema after 5 min, the maximum score was 1 hour after application.
REVERSIBILITY: reversible within 48 h after application

Other effects:

none

Table 1: Irritant/corrosive response data at each observation time

Score at time point / Reversibility		Cornea	Iris	Conjunctivae	Chemosis
5 min		0 (6)	0 (6)	1 (6)	0 (6)
15 min		0 (6)	0 (6)	1 (6)	0 (6)
30 min		0 (6)	0 (6)	2 (5) / 1 (1)	1 (5) / 0 (1)
1 h		0 (6)	0 (6)	2 (6)	1 (6)
2 h		0 (6)	0 (6)	2 (6)	1 (6)
4 h		0 (6)	0 (6)	2 (3) / 1 (3)	0 (6)
8 h		0 (6)	0 (6)	2 (2) / 1 (4)	0 (6)
24 h		0 (6)	0 (6)	1 (6)	0 (6)
48 h		0 (6)	0 (6)	0 (6)	0 (6)
72 h		0 (6)	0 (6)	0 (6)	0 (6)
4 d		0 (6)	0 (6)	0 (6)	0 (6)
Average 24, 48, 72 h		0	0	0.33	0
Reversibility *		c.	c.	c.	c.

 

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

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, 2-Octyldodecan-1-ol is slightly irritating to the eyes.

Executive summary:

Based on the result of this study, 2-Octyldodecan-1-ol is slightly irritating to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute skin irritation studies with Guerbet alcohols have been conducted in both humans and rabbits. In rabbits 6 respresentatives of the category of Guerbet alcohols showed only slight irritant effects. Studies in human volunteers showed no irritant effects.

Data on eye irritation are available for 6 respresentatives of the category. All substances showed only slight irritant effects in the rabbit eye.

No data on respiratory irritation are available for any substance of the category.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The available data are conclusive but not sufficient for classfication of 2 -octyl-dodecan-1-ol with regard to irritation/corrosion.