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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:
key study
Study period:
24 fev 1988 to 27 fev 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
as the tested product is not the registered substance.
Justification for type of information:
As an ingredient for a medical device, tests and protocols established from the O.E.C.D. guideline and International standard NF EN ISO 10993-10 concerning biological evaluation of medical devices are already available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(DRAIZE TEST)
GLP compliance:
yes
Remarks:
in the spirit of

Test material

Constituent 1
Reference substance name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
EC Number:
946-247-6
Molecular formula:
Not relevant for a UVCB substance
IUPAC Name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
Test material form:
liquid
Details on test material:
The tested material is a mixture containing 99% corn oil oxidized (glycerides, C10-C20 sat. and unsat.) and 1% fragrance.
Specific details on test material used for the study:
The test material is a mixture named "Sanyrene" ref PB17 containing 99% w/w of registered subtance (oxidised corn oil).
Batch number HM12.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Origine : Elevage CEGAV - 61350 Saint Mars D'Egrenne ; They were kept during a minimal 5 day acclimatation period.

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
24 hours
Observation period:
24 hours / 72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The product PB 17 does not induce skin irritation (index 0)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The susbtance tested PB17 is not skin irritant.

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