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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
April 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Data on analytical purity, animal husbandry and the dose applied are missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
yes
Remarks:
data on analytical purity, animal husbandry and dose applied are missing
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Decyl oleate
EC Number:
222-981-6
EC Name:
Decyl oleate
Cas Number:
3687-46-5
IUPAC Name:
decyl octadec-9-enoate
Details on test material:
- Name of test material (as cited in study report): oleate de decyle S
- Analytical purity: no data
- Code: 10117
- Lot/batch No.: 0609 G

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
other: untreated sites of the same animal served as control
Duration of treatment / exposure:
4 h
Observation period:
5 days
Reading time points: 1, 24, 48 and 72 h, and 5 days
Number of animals:
3 males
Details on study design:
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, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
animal #1
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:
animal #2
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:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritant / corrosive response data:
3/3 animals had very slight erythema (grade 1) 1 hour after exposure ended. Very slight oedema (grade 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point, while 2/3 did not have edema at any reading time point. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well defined erythema. The erythema cleared in 1/3 animals within 48 hours and in the remaining 2 within 5 days. All irritation reactions were completely reversible within 5 days.

Any other information on results incl. tables

Table 1: Erythema and edema scores for the individual animals:

Animal No.

Reading time point

Erythema score

Edema score

1

1 h

1

0

 

24 h

1

0

 

48 h

1

0

 

72 h

1

0

 

5 d

0

0

2

1 h

1

0

 

24 h

1

0

 

48 h

0

0

 

72 h

0

0

 

5 d

0

0

3

1 h

1

1

 

24 h

2

1

 

48 h

1

1

 

72 h

1

1

 

5 d

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