2-hexyldecan-1-ol

Skin irritation / corrosion

Administrative data

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test material

Test material information

Constituent 1

Constituent 2

Reference substance name:

2-hexyldecan-1-ol

EC Number:

219-370-1

EC Name:

2-hexyldecan-1-ol

Cas Number:

2425-77-6

Molecular formula:

C16H34O

IUPAC Name:

2-hexyldecan-1-ol

Details on test material:

- Name of test material (as cited in study report): 2-Hexyl-decanol
no more details mentioned

Test animals

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: Altromin 2023, ad libitum, supplied by Altromin GmbH, Lage, Germany
- Water: 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

Test system

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 intact and scarified skin, 3 female and 3 male animals per group and concentration

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: no wrap

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

SCORING SYSTEM: erythema: according to Draize-Scheme (0-4), edema: skin-thickness in mm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

3.17

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 2 ml/kg bw, scarified skin

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

3.06

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 2 ml/kg, intact skin

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.89

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 1 ml/kg bw, scarified skin

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.89

Reversibility:

fully reversible within: 5 days

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 = 1.50, intact = 1.39;
1 ml test substance, scarified = 1.22, intact = 1.22.
- Edema:
control group, scarified = 3.64 mm, intact = 3.64 mm;
2 ml test substance, scarified = 3.96 mm (Draize score: 1.67), intact = 3.91 mm (Draize score: 1.67);
1 ml test substance, scarified = 3.76 mm Draize score: 0.67) , intact = 3.69 mm (Draize score 0.67).
REVERSIBILITY: yes

Other effects:

none

Any other information on results incl. tables

Table 1: Irritant/corrosive response data, mean

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	3.6 / 3.6	0 / 0	3.6 / 3.6
5 min	0.7 / 0.8	3.6 / 3.6	0.3 / 0.3	3.7 / 3.7	0 / 0.2	3.6 / 3.6
15 min	0.7 / 1.3	3.6 / 3.8	0.8 / 0.8	3.7 / 3.7	0 / 0.2	3.6 / 3.6
30 min	1.2 / 1.7	3.7 / 4.1*	1.2 / 1.2	3.8 / 3.8*	0 / 0	3.6 / 3.6
1 h	1.8 / 1.8	3.9* / 4.1*	1.5 / 1.3	3.9* / 3.8	0 / 0	3.6 / 3.7
2 h	1.8 / 2.0	4.0* / 4.3*	1.3 / 1.7	3.9* / 3.9*	0.2 / 0	3.6 / 3.6
4 h	1.8 / 2.2	4.1* / 4.3*	1.7 / 1.8	3.8* / 4.0*	0.2 / 0	3.6 / 3.7
1 d	1.5 / 1.8	4.1* / 4.1*	1.7 / 1.5	3.8 / 3.9*	0 / 0	3.7 / 3.7
2 d	1.5 / 1.3	4.0* / 3.9*	1.0 / 1.2	3.7 / 3.7	0 / 0	3.6 / 3.6
3 d	1.2 / 1.3	3.7 / 3.9*	1.0 / 1.0	3.6 / 3.7	0 / 0	3.6 / 3.7
4 d	0.8 / 1.3	3.6 / 3.8	0.8 / 0.7	3.6 / 3.7	0.2 / 0	3.8 / 3.6
5 d	0.7 / 0.8	3.5 / 3.7	0.2 / 0.5	3.6 / 3.6	0 / 0	3.7 / 3.6
6 d	0.3 / 0.3	3.5 / 3.7	0 / 0.2	3.6 / 3.6	0 / 0	3.7 / 3.6
7 d	0 / 0	3.6 / 3.6	0 / 0	3.6 / 3.6	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

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

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