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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 - 19 Jan 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Each animal is additionally treated with 3 different dilutions of test substance. No analytical purity of test substance given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
each animal is additionally treated with 3 different dilutions of test substance
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(Commission Directive 84/449/EEC)
Deviations:
yes
Remarks:
each animal is additionally treated with 3 different dilutions of test substance
GLP compliance:
yes

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: approx. 12 - 16 weeks
- Weight at study initiation: 2.15 - 2.17 kg
- Housing: individually in metal cages
- Diet: Rabbit Diet (Preston Farmers Limited, Lincolnshire, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 59 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: diethyl phthalate/ethanol (1:1)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentrations: 2, 10, 50% (w/w) and 100%
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Reading time point: 1, 24, 48, 72 hours and 7 days
Number of animals:
2 males and 1 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The treated skin was covered with a gauze patch and held in place with surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Skin sites were gently swabbed with cotton wool soaked in ethanol.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversiblitiy: not applicable
Remarks on result:
other: undiluted test substance
Irritant / corrosive response data:
Undiluted test substance: No adverse skin reactions were noted at any treated skin site 1 hour after patch removal. Very slight erythema was noted at the time points 24 and 48 hours. Desquamation was noted at two treatment sites at the 72-hour observation and at one treatment site at the 7-day observation. Very slight oedema was noted at one treatment site at the 24-hour observation.
50% dilution: Very slight erythema was noted at the reading time points 24 and 48 hours and at two treatment sites at the 72-hours observation. Desquamation was noted at two treatment sites at the 7-day observation. Very slight oedema was noted at all treatment sites at the 24-hour observation and at one treatment site at the 48-hour observation.
10% dilution: Very slight erythema was noted at one treatment site one hour after patch removal and at all treatment sites at the 24-and 48-hour observations. Very slight erythema or desquamation was noted at two treatment sites at the 72-hour observation. Desquamation only was noted at these sites at the 7-day observation. Slight oedema was noted at one treatment site at the 24-hour observation with very slight oedema at the 48-hour observation.
2% dilution: Very slight erythema was noted at one treatment site one hour after patch removal. Very slight or well-defined erythema was noted at all treatment sites at the 24-hour observation. Very slight erythema was noted at two treatment sites at the 48 and 72-hour observations with desquamation only at these sites at the 7-day observation. Slight oedema was noted at one treatment site at the 24-hour observation with very slight oedema at the 48-hour observation.

Any other information on results incl. tables

Table 1: Individual skin examination scores with 100, 50, 10 and 2% test substance

Animal

Concentration %

Erythema/Eschar formation

Oedema formation

1 h

24 h

48 h

72 h

7 d

Mean 24/48/72 h

1 h

24 h

48 h

72 h

7 d

Mean 24/48/72 h

1 (male)

100% (undiluted)

0

1

1

0D

0D

0.67

0

1

0

0

0

0.33

50%

0

1

1

0

0

0.67

0

1

0

0

0

0.33

10%

0

1

1

0D

0D

0.67

0

0

0

0

0

0

2%

0

1

0

0

0

0.33

0

0

0

0

0

0

2 (male)

100% (undiluted)

0

1

1

0

0

0.67

0

0

0

0

0

0

50%

1

1

1

1

0D

1

0

1

1

0

0

0.67

10%

0

1

1

0

0

0.67

0

0

0

0

0

0

2%

1

1

1

1

0D

1

0

0

0

0

0

0

3 (female)

100% (undiluted)

0

1

1

0D

0

0.67

0

0

0

0

0

0

50%

0

1

1

1

0D

1

0

1

0

0

0

0.33

10%

1

1

1

1

0D

1

0

2

1

0

0

1

2%

0

2

1

1

0D

1.33

0

2

1

0

0

1

D: desquamation

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 undiluted test substance (100%) was not irritating to the skin. Also the test substance concentrations of 2, 10 and 50% in ethanol/diethylphthalat (1:1) did not show an irritation potential.