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Toxicological information

Skin irritation / corrosion

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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:
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:
other: Hazardous Substances, Part. 191, section 11, FDA, Washington 1965
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
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
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
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
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.