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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
Study period:
19 - 22 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, esters with pentaerythritol
EC Number:
285-547-5
EC Name:
Fatty acids, C16-18, esters with pentaerythritol
Cas Number:
85116-93-4
IUPAC Name:
85116-93-4
Details on test material:
- Name of test material (as cited in study report): fatty acids, C16-18, esters with pentaerythritol
- Physical state: white, solid
- Analytical purity: 99%
- Lot/batch No.: 51531022
- Stability under test conditions: 18 months
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable

Any other information on results incl. tables

Erythema score

Animal Number

1 day

2 days

3 days

Mean Score

1226

0

0

0

0

1230

0

0

0

0

1231

0

0

0

0

 

Edema Score

Animal Number

1 day

2 days

3 days

Mean Score

1226

0

0

0

0

1230

0

0

0

0

1231

0

0

0

0

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