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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. (Limited documentation but relevant data given)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation but relevant data given
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): pentaerythritol C7-C10 Tetraester
- Analytical purity: according to the manufacturer, the test was conducted with the pure substance without the addition of any substances.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 5.0 - 5.2 g

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
4 d
Reading time points: 30 - 60 min, 24, 48, 72 and 96 h
Number of animals:
3 (females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansing with clean warm water
- Time after start of exposure: 4 h (upon removal of the dressing)

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Erythema scores

Animal Number

24 hours

48 hours

72 hours

96 hours

Mean Score

26

2

1

1

0

1.3

35

2

2

1

0

1.7

36

2

1

1

0

1.3

 

Table 2: Edema Score

Animal Number

24 hours

48 hours

72 hours

96 hours

Mean Score

26

1

0

0

0

0.3

35

1

0

0

0

0.3

36

1

0

0

0

0.3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified