Undecanol, branched and linear

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study reasonably well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Cited as Directive 84/449/EEC, B.4

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C6-12

EC Number:

271-642-9

EC Name:

Alcohols, C6-12

Cas Number:

68603-15-6

IUPAC Name:

octan-1-ol

Details on test material:

- Name of test material (as cited in study report): Tradename Lial 111 C6-12 alcohols Type A

- Physical state:

- Storage condition of test material:

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg
- Housing: stainless steel cages
- Diet: pelleted complete diet
- Water: tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (+/-2)
- Humidity (%): 55 (+/-15)
- Air changes (per hr): min. 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

Examination time points: 1, 24, 48 and 72 hours, 5 and 7 days.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 6x6cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or appropriate solvent
- Time after start of exposure: 4h

SCORING SYSTEM:Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72h

Score:

1.83

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/48/72h

Score:

1.5

Max. score:

1.7

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: Individual 24+48+72 hour scores 3 animals scored 2 the  remaining 3 scored 1.7. Group mean 24+48+72 hour score 1.83.
- Oedema: Individual 24+48+72 hour scores 3 animals scored 1.3 the  remaining 3 scored 1.7. Group mean 24+48+72 hour score 1.5.

Other effects:

None reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Following a 4 hour occluded exposure to rabbit skin, LIAL 111 (C11) was not a skin irritant according to EU criteria (group mean 24+48+48 hour scores <2). With erythema scores all >=1.5 LIAL 111 is classifiable as a mild (slight) skin irritant according to the GHS.

Classification: not irritating