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EC number: 221-882-5 | CAS number: 3268-49-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-07-01 to 1985-08-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 Jul 2015
- Deviations:
- yes
- Remarks:
- reading time point 30 min instead of 1 h, 24 h occlusive exposure tested on the same animals at a different test site, no information on analytical purity
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals; Office of Pesticide Programs, U.S. Environmental Protection Agency, Office of Pesticides and Toxic Substances, November 1982; Section 81-5, Primary Dermal
- Version / remarks:
- adopted Aug 1978
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA: Health Effects Test Guidelines, Office of Toxic Substances, Office of Pesticides and Toxic Substances, United States Environmental Protection Agency, August 1982 Acute Exposure, Primary Dermal Irritation
- Version / remarks:
- adopted 26 Jul 1979
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(methylthio)propionaldehyde
- EC Number:
- 221-882-5
- EC Name:
- 3-(methylthio)propionaldehyde
- Cas Number:
- 3268-49-3
- Molecular formula:
- C4H8OS
- IUPAC Name:
- 3-(methylthio)propionaldehyde
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Hazleton Dutchland, Inc., Denver, Pennsylvania, USA
- Age at study initiation: At least 8 weeks
- Equilibration period: 38 days
- Housing: Individually housed
- Diet: Lab Rabbit Chow HF (Purina #5326), ad libitum
- Water: Tap water supplied by an automatic watering system (Municipal water), ad libitum
Environmental conditions:
- Temperature: 60-70°F (16-21 °C)
- Humidity: 30-70%
- Light cycle: 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h (semi-occlusive dressing) and 24 h (occlusive dressing)
- Observation period:
- 14 days
Reading time points:
4 h exposure: 30 min, 24, 48 and 72 h after patch removal
24 h exposure: 24, 48 and 72 h after patch removal - Number of animals:
- 6 (The same 6 animals were used for both sets of application sites, 4 and 24 h exposure.)
- Details on study design:
- TEST SITE
- Area of exposure: closely clipped dorsal area of the trunk
- % coverage: 10
- Type of wrap if used:
4h exposure, semi-occlusive conditions: The test material was applied beneath a gauze square 1x1 cm, placed on each of two test sites nearest the head and held in place with a non-irritating tape. Gauze was then wrapped around the animal and covered with porous tape.
24 h exposure, occlusive conditions: The test material was applied beneath a gauze square 1x1 cm, placed on each of two test sites posterior to the 4 h sites and held in place with a non-irritating tape. Plastic sheeting was then wrapped around the animal and secured with tape to retard evaporation and keep the test material in contact with the skin without pressure.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.
OBSERVATION TIME POINTS:
4 h exposure, semio-occlusive conditions: 30 minutes, 24, 48 and 72 h after patch removal
24 h exposure, occlusive conditions: 24, 48 and 72 h after patch removal
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Desquamation on day 7;
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Desquamation on day 10 & 14;
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Desquamation on day 10 & 14;
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Desquamation on day 7, 10 & 14;
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Desquamation on day 14;
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Desquamation on day 7, 10 & 14;
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other:
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other:
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other:
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other:
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other:
- Remarks:
- 4 h semi-occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other:
- Remarks:
- 4 h semi-occlusive exposure
- Irritant / corrosive response data:
- 4 h exposure: Irritation was generally moderate but transient and consisted of well-defined to moderate erythema (score 2 and 3) and slight to severe edema (score 2 – 4) in all animals at the 4 h and 24 h reading. 48 and 72 h after patch removal, very slight to moderate to severe erythema (score 1 – 3) and very slight to moderate edema (score 1 – 3) was still present in all animals. About 7 days after patch removal, 5/6 rabbits had very slight erythema (score 1) and 1/6 rabbits had well defined erythema (score 2). Very slight erythema (score 1) persisted in 3/6 rabbits until study termination on Day 14. Very slight edema (score 1) was observed up to Day 7 in 4/6 rabbits and fully reversible in all animals until study Day 10.
24 h exposure: All animals showed moderate to severe erythema (score 3-4) during the whole study period and moderate to severe erythema (score 3-4), which remained slight to moderate (score 2-3) until study termination.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test - 4 hours semi-occluded exposure (median scores of the two exposure sites) |
Time point |
Erythema (max score 4) |
Edema (max score 4) |
4.5 hrs |
2/3/2/2/2/2 |
3/3,5/3/3/2/3 |
24 hrs |
2/3/3/2/3/3 |
3/2,5/3,5/3/2/2 |
48 hrs |
2/3/3/1/2/2 |
2/2/2,5/2/2/2 |
72 hrs |
2/2/3/1/2/2 |
2/2/2/2/1/1 |
Day 7 |
1#/1/1/1,5#/1/1# |
1/1/1/1,5/0/0 |
Day 10 |
1/0#/0#/1#/0/1# |
0/0/0/0/0/0 |
Day 14 |
1/0#/0#/1#0,5#/1# |
0/0/0/0/0/0 |
Average 24hr/48hr/72hr |
2/2.67/3/1.33/2.33/2.33 |
2.33/2.17/2.67/2.33/1.67/1.67 |
Reversibility*), **) |
nc./c/c/nc/nc/nc |
c/c/c/c/c/c |
Time for Reversion (day) |
-/10/10/-/-/- |
10/10/10/10/7/7 |
*) Reversibility: c = completely reversible; nc = not completely reversible; n = not reversible
# Desquamation
**) The observation time did not extend beyond 14 days, therefore, full reversibility of the skin effects can not be proved. However, skin lesions showed a clear tendency of reversibility. At study termination, reversibility was complete in 2/6 animals and almost complete in the remaining 4/6 animals. Therefore, a full reversibility in all animals seems to be very likely.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- CLP: Skin Irrit. 2, H315 according to Regulation (EC) No. 1272/2008
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