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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:
September until October 1986
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyloctan-1-ol
EC Number:
223-470-0
EC Name:
2-butyloctan-1-ol
Cas Number:
3913-02-8
Molecular formula:
C12H26O
IUPAC Name:
2-butyloctan-1-ol
Details on test material:
- Name of test material (as cited in study report): Isofol 12
no more details mentioned

Test animals

Species:
rabbit
Strain:
other: White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chr. Leuschner & Co, Loehndorf, Germany
- Age at study initiation: approximately 7 months
- Weight at study initiation: 2.18 - 2.91 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: 1 quarantine week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 5
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test substance was applied to a linen patch 2.5 cm x 2.5 cm. This patch was covered with plastic foil of the same size, placed on the shaved intact dorsal skin of the animals and secured with an adhesive plaster between the fore and hind limbs.
Duration of treatment / exposure:
4 hours
Observation period:
Signs of erythema and oedema were recorded at 30 - 60 min, 24, 48, 72, 96, 120 h, 7, 14 and 21 days after patch removal. Food consumption and bodyweight were recorded daily.
Number of animals:
3 male
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: adhesive plaster, Leukoplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not mentioned
- Time after start of exposure: 4 hours

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

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.28
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.56
- Edema: 0.0
REVERSIBILITY: fully reversible 21 days after patch removal
Other effects:
none

Any other information on results incl. tables

Table #: Irritant/corrosive response data, mean

Score at time point

Reversibility

ISOFOL 12

Erythema

Edema

30 - 60 min

0 / 0 / 0

0 / 0 / 0

24 h

1 / 1 / 1

0 / 0 / 0

48 h

1 / 0 / 0

0 / 0 / 0

72 h

1 / 0 / 0

0 / 0 / 0

4 d

1 / 0 / 0

0 / 0 / 0

5 d

1 / 0 / 0

0 / 0 / 0
7 d 1* / 1* / 1* 0 / 0 / 0
14 d 0 ** / 1 ** / 0 0 / 0 / 0
 21 d 0 / 0 / 0 0 / 0 / 0
 average 24, 48, 72 h 0.56 0
 Reversibility c.  c.

 

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

* = formation of scab; ** = casting of epidermis

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study 2-Butyloctan-1-ol is slightly skin irritating.
Executive summary:

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