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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:
weight of evidence
Study period:
12 Nov - 12 Dec 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Lack of study details, amount and concentration of test substance applied not specified and analytical purity of test substance not specified

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Lack of study details, amount and concentration of test substance applied is not specified and analytical purity of test substance not specified
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Isooctadecanoic acid, mono-, di- and triesters with triglycerol
EC Number:
291-548-1
EC Name:
Isooctadecanoic acid, mono-, di- and triesters with triglycerol
Cas Number:
90431-25-7
IUPAC Name:
90431-25-7
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
other: not required, untreated sites of the same animal served as control
Duration of treatment / exposure:
not specified (4 hours according to OECD 404 which is given as Method)
Observation period:
72 hours
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Only slight erythema was seen on skin of all three animals tested starting 1 hour following application and was fully reversible within 72 hours following application.
Other effects:
None

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:
CLP: not classified