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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:
12 Nov - 24 Nov 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 17 Jul 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.73-3.02 kg
- Housing: animals were housed individually in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet (Special Diets Services LTD, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
3 min and 1 and 4 h (one animal)
4 h (two animals)
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: area on the back
- Type of wrap: The test substance was applied to the skin and covered with gauze patch (2.5 cm x 2.5 cm). The patch was secured in position with a strip of surgical adhesive tape (BLENDERM, 2.5 cm x 4.0 cm). Additionally, the trunk was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: 3 min and 1 and 4 h (one animal); 4 h (two animals)

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: loss of skin elasticity after 72 h, slight desquamation after 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites at the 1 h observation and at two treated skin sites at the 24, 48 and 72 h observations. Very slight oedema was noted at all treated skin sites at the 1 h observation, at two treated skin sites at the 24 h observation and at one treated skin site at the 48 and 72 h observations. Loss of skin elasticity was noted at two treated skin sites at the 72 h observation. Slight desquamation was noted at two treated skin sites after 7 days.
One treated skin site appeared normal at the 24-hour observation.

3 min exposure period: No evidence of skin irritation was noted during the study.

1 h exposure period: Very slight erythema was noted at the treated skin site at the 24, 48 and 72 h observations. Loss of skin elasticity was noted at the treated skin site at the 72 h observation. Slight desquamation was noted at the treated skin site after 7 days..

Any other information on results incl. tables

Table 1. Results of the skin irritation study following 4 h exposure.

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

1

1

1

1

1

1

24 h

1

1

0

0

1

1

48 h

1

1

0

0

1

0

72 h

1LE

1

0

0

1LE

0

7 days

0D

 

0

0

0D

0

Mean value
24 + 48 + 72 h

1.00

1.00

0

0

1.00

0.33

D: Desquamation (slight)

LE: Loss of skin elasticity

Table 2. Results of the skin irritation study following 3 min and 1 h exposure.

Observation time

Exposure period

3 min

1 h

Erythema

Edema

Erythema

Edema

1 h

0

0

0

0

24 h

0

0

1

0

48 h

0

0

1

0

72 h

0

0

1LE

0

7 days

0

0

0D

0

D: Desquamation (slight)

LE: Loss of skin elasticity

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.
Executive summary:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight edema. Incidents of loss of skin elasticity were also noted. Slight desquamation was noted at two treated skin sites at the 7-day observation. One treated skin site appeared normal at the 24-hour observation. No corrosive effects were noted. Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.