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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation but relevant data given
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C5-10, esters with pentaerythritol
EC Number:
270-291-9
EC Name:
Fatty acids, C5-10, esters with pentaerythritol
Cas Number:
68424-31-7
Molecular formula:
C25H44O8 to C45H84O8
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 or test system 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