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Description of key information

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:
reference to same study
Qualifier:
according to
Guideline:
other: Hazardous Substances, Part. 191, section 11, FDA, Washington 1965
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
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.