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Diss Factsheets

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:
2007-05-17 to 2007-05-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of Propanoic acid, -1-methyl, 2-hydroxy-, (C12-14)-alkyl ester, Propanoic acid, 2-hydroxy-, 2-(C12-14-alkyloxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester and Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester
EC Number:
941-488-3
Molecular formula:
UVCB Substance of nominal composition C18H34O5 - C20H38O5
IUPAC Name:
A mixture of Propanoic acid, -1-methyl, 2-hydroxy-, (C12-14)-alkyl ester, Propanoic acid, 2-hydroxy-, 2-(C12-14-alkyloxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester, Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester and Propanoic acid, 2-hydroxy-, 2-(2-(2-(2-(2-(2-(2-(2-(C12-14-alkyloxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoeth oxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethoxy)-1-methyl-2-oxoethyl ester
Details on test material:
- Name of test material (as cited in study report): STEPAN MILD-L3
- Physical state: Clear liquid
- Lot/batch No.: Lot# 17821-040407
- Stability under test conditions: stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 2.88 - 2.94 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61 - 72°F
- Humidity (%): 30 - 70%
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hour light:dark cycle

IN-LIFE DATES: From: 2007-05-17 To: 2007-05-20

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): neat
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 female
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 2.5 cm2, 2-layer gauze patch held in place with non-irritating Kendall Curity Standard Porous tape and covered with semi-occulsive plastic overwrap again secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material removed but washing not specified.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There were no skin reactions in any of the three test animals.
Other effects:
No other effects noted in any of the three animals

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material does not meet the criteria for classification as a skin irritant as defined in the EU CLP Regulation (EC) No. 1272/2008 under the conditions of the study.
Executive summary:

In a study performed to OECD Guideline 404 and US EPA OPPTS 870.2500, 0.5 mL of the neat test material was applied to a clipped test site on each of three New Zealand white rabbits (female) and covered with a 2 layer gauze patch secured with non-irritating Kendall Curity Standard Porus tape covered with a semiocclusive plastic overwrap secured with non-irritating Kendall Curity Standard Porus tape for 4 hours. After 4 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 4.5, 24, 48 and 72 hours.

Semi-occlusive 4 hour exposure to 0.5mL of the test material did not elicit any skin reaction at any of the observation points. No other test material effects were noted in the test animals.

The test material does not require classification for skin irritation according to EU the CLP Regulation 1272/2008.