Registration Dossier

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:
18/06/1997-21/06/1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

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:
Docosan-1-ol
EC Number:
211-546-6
EC Name:
Docosan-1-ol
Cas Number:
661-19-8
Molecular formula:
C22H46O
IUPAC Name:
docosan-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, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.81 - 3.15 kg
- Housing:individually housed in suspended metal cages
- Diet: STANRAB SQC Rabbit diet, ad libitum
- Water: mains water, ad libitum
- Acclimation period:minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 59-62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5g of test material was moistened with 0.5ml distilled water



Duration of treatment / exposure:
4 hour(s)
Observation period:
Ca. 1h, 24h, 48h, 72h after patch removal
Number of animals:
3F
Details on study design:
TEST SITE
- Area of exposure: shorn dorsal  surface of the skin,  2.5 x 2.5 cm
- Type of wrap if used: gauze patch secured in position with a strip of surgical adhesive tape, wrapped in an elastic corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4h


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
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:
The test material produced a primary irritation index of 0.0. 
Other effects:
No evidence of skin irritation was noted during the study other than very slight  erythema at one test site at 1 hour after patch removal. All other scores  were 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Kalcol 220-80 is not a skin irritant when applied to rabbit skin undiluted in a 4 hour semi-occlusive exposure. Group mean 24+48+72 hours were 0.
Executive summary:

In the skin irritation study 0.5g of test material was moistened with 0.5ml distilled water and applied onto the skin of 3 female rabbits and kept under semi-occlusive dressing for 4 hours. The exposure area was shaved from hair prior to the treatment. After 4 -hour exposure any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water. The skin reaction was evaluated at 1h, 24 h, 48 h, 72 h after patch removal according to Draize scoring system. The mean primary dermal irritation index was 0. The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.