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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
N/A to 1983-08-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted with methods similar to OECD Guideline 404. However, limited information was provided on the test substance, treatment area was smaller than the recommended 6 cm2, scorings of skin reactions were only made at 24 and 72 hours, and animals were treated for 24 hours rather than the recommended 4 hours.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited information was provided on the test substance, treatment area was smaller than the recommended 6 cm2, scorings of skin reactions were only made at 24 and 72 hours, and animals were treated for 24 hours rather than the recommended 4 hours.
Principles of method if other than guideline:
N/A
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 3-mercaptopropionate
EC Number:
220-912-4
EC Name:
Methyl 3-mercaptopropionate
Cas Number:
2935-90-2
Molecular formula:
C4H8O2S
IUPAC Name:
methyl 3-sulfanylpropanoate
Details on test material:
- Name of test material (as cited in study report): methyl 3-mercaptopropionate
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc.
- Age at study initiation: adult
- Weight at study initiation: N/A
- Housing: Animals were housed individually.
- Diet (e.g. ad libitum): ad libitum (Purina Lab Rabbit Chow)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: minimum of 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): Every attempt was made to maintain temperatures at 70+/-4 degrees F.
- Humidity (%): Every attempt was made to maintain a relative humidity of 40-60 %.
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: N/A To: N/A

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Animals were clipped free of hair. Treated areas included both intact and abraded skin.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of treatment / exposure:
24 hours
Observation period:
72 hours (Erythema and edema were scored at 24 and 72 hours.)
Number of animals:
3 males and 3 females were included in the study (the same animals were used for both the intact and abraded skin treatments).
Details on study design:
TEST SITE
- Area of exposure: The test substance was administered to one abraded site and one intact site under a 1" to 1 1/2" square gauze patch (two layers thick) on the back of each animal with the sites rotated over various areas of the clipped skin. Abrasions were minor incisions through the stratum corneum, but not sufficiently deep to disturb the dermis or to produce bleeding.
- % coverage: N/A
- Type of wrap if used: occlusive. The gauze patches which the test substance was introduced under were secured in place with Dermiclear brand transparent tape. The entire trunk of each animal was wrapped with a non-absorbent binder. The animals were immobilized in a stock.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The study did not indicate any washing procedure after treatment. However, the skin was wiped to remove any test substance still remaining after treatment.
- Time after start of exposure: The skin was wiped clear of remaining test substance at 24 hours after initiation of treatment.


SCORING SYSTEM: The Draize Scale was used for scoring primary skin irritation. See below for the scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Remarks on result:
other: for intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
other: for intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Remarks on result:
other: for intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
other: for intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Remarks on result:
other: for abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
other: for abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Remarks on result:
other: for abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
other: for abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: for intact and abraded skin
Irritant / corrosive response data:
No erythema, edema, or other dermal effects were noted at 24 or 72 hours after administration of the test substance. Therefore, the primary irritation score was calculated to be zero.
Other effects:
N/A

Any other information on results incl. tables

N/A

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating; no classification
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was evaluated for skin irritation in rabbits. No erythema, edema or other dermal effects were noted at 24- or 72-hours after administration of the test substance. Therefore, the primary irritation score was calculated to be zero and the test substance was determined to be non-irritating.
Executive summary:

N/A