Registration Dossier

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:
01 to 11 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Purity of test substance not reported. No GLP statement. Limited reporting details.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2015
Deviations:
yes
Remarks:
no rationale for in vivo testing, no initial testing with one animal
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
Purity of test substance not reported. No GLP statement. Limited reporting details.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylene dinonanoate
EC Number:
255-350-9
EC Name:
Propylene dinonanoate
Cas Number:
41395-83-9
Molecular formula:
C21H40O4
IUPAC Name:
1-(nonanoyloxy)propan-2-yl nonanoate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Legard
- Weight at study initiation: 1.97 kg

IN-LIFE DATES: 01 Mar 1991 to 08 Mar 1991

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: not stated

REMOVAL OF TEST SUBSTANCE
- Washing: no washing was performed

OBSERVATION TIME POINTS
1, 24, 48, and 72 h

SCORING SYSTEM:
No details reported.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable

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.