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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:
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0
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
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
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
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
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
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*)

 -

 *) 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.