Hexadecan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996/03/13-1996/03/16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecan-1-ol

EC Number:

253-149-0

EC Name:

Hexadecan-1-ol

Cas Number:

36653-82-4

Molecular formula:

C16H34O1

IUPAC Name:

hexadecan-1-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: David Percival Ltd., Moston, SAndbach, Cheshire, UK.

- Age at study initiation: 12-16 weeks old

- Weight at study initiation: 2.36-2.54 kg

- Housing: The animals were individually housed in suspended metal cages.

- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK (ad libitum)

- Water: tap water (ad libitum)

- Acclimation period: Minimum of 5 days.


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 18-19C

- Humidity (%): 49-60%

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: Not stated.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped free of fur

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5g test material

VEHICLE

- Amount(s) applied (volume or weight with unit): 0.5ml of distilled water

Duration of treatment / exposure:

4 hour(s)

Observation period:

Examinations at 1h, 24h, 48h, 72h. Post-exposure period 16 hours

Number of animals:

2 male, 1 female

Details on study design:

TEST SITE

- Area of exposure: dorsal flank

- % coverage: 2.5x2.5cm

- Type of wrap if used: cotton gauze patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in elasticated corset (TUBIGRIP).


REMOVAL OF TEST SUBSTANCE

- Washing (if done): When the corset and patches were removed at the end of the 4 hour exposure period, any residual test material was removed by gentle swabbing with cotton.

- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" In Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

AVERAGE SCORE

- Erythema: Erythema (grade 1) observed at 1 hour after removal of dressings. All scores at other time points 0. 
- Oedema: No oedema observed.

REVERSIBILITY: Initial erythema regressed in the first 24 hours. All scores at 24, 48 and 72 hours were 0.

Other effects:

None reported.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 2
60 min	1/1/1	0/0/0
24 h	0/0/0	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.25	0
Reversibility*)	c	-

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

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following a 4 hour semi-occlusive exposure of Kalcol 6098 to rabbit skin there was no evidence of skin irritation between 24 and 72 hours after patch removal. Kalcol 6098 is not a skin irritant according to EU or GHs criteria.