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EC number: 601-101-8 | CAS number: 111497-86-0
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 December 1997 - 09 January 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- EC Number:
- 601-101-8
- Cas Number:
- 111497-86-0
- Molecular formula:
- Molecular formula not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): CN386 (Amine synergist)- Physical state: Clear colourless liquid- Lot/batch No.: CK664- Storage condition of test material: Room temperature and humidity
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Ace Animals, Boyertown, PA, USA- Weight at study initiation: 2.2 - 2.6 kg- Housing: Individually in suspended wire cages- Diet (e.g. ad libitum): Purina Rabbit Chow (Diet no. 5321)- Acclimation period: At least 5 daysENVIRONMENTAL CONDITIONS- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml/rabbit
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE- Area of exposure: 2.5 x 2.5 cm- Type of wrap if used: PlasticREMOVAL OF TEST SUBSTANCE- Washing (if done): Gentle washing with distilled water at the end of the exposure period, before scoring for dermal reactions- Time after start of exposure: 4 hoursSCORING SYSTEM: Numerical Draize technique
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Erythema scores, very slight to well defined at 1 hour following patch removal, ranged from absent to severe through Day 1 and cleared by Day 14.One animal had poor hair regrowth on Day 7, which cleared by Day 14. Edema scores generally ranged from absent to slight through Day 7 and cleared by Day 14, with the exception of a score 3 (moderate) in one animal at 24 hours.
Any other information on results incl. tables
Table 1: Bodyweights (BW) | ||||
Rabbit N° | 1 | 2 | 3 | |
Pretest BW (kg) | 2.2 | 2.6 | 2.2 | |
Terminal BW | 2.5 | 2.5 | 2.6 |
Table 2: Erythema and eschar formation | ||||
Rabbit N° | 1 | 2 | 3 | Mean |
Time after patch removal | Score | |||
1 h | 1 | 1 | 2 | |
24 h | 1 | 2 | 4 | 2.33 |
48 h | 2 | 2 | 4 | |
72 h | 0 | 2 | 4 | 2.00 |
7 d | 0 | 2 | 4 | |
14 d | 0 | 0 | 0 | |
Table 3: Edema | ||||
Rabbit N° | 1 | 2 | 3 | Mean |
Time after patch removal | Score | |||
1 h | 0 | 0 | 2 | |
24 h | 0 | 3 | 2 | 1.67 |
48 h | 0 | 2 | 2 | |
72 h | 0 | 2 | 2 | 1.33 |
7 d | 0 | 1 | 2 | |
14 d | 0 | 0 | 0 | |
Sum of mean scores | 7.33 | |||
PDII | 3.67 | |||
Table 4: Systemic observations | ||||
Rabbit N° | 1 | 2 | 3 | |
Time after patch removal | ||||
1 h | A | A | A | |
24 h | A | A | A | |
48 h | A | A | A | |
72 h | A | A | A | |
7 d | A | A | A | |
14 d | A | D | A | |
A: normal; D: diarrhea |
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test substance was considered to be irritating but not corrosive to skin.
- Executive summary:
A study was performed to assess the skin irritation potential of the test substance to the skin of New Zealand White rabbits according to OECD Guideline 404.
0.5 mL of test substance was applied to the clipped skin area on the back of each animal under a 25 x 25 mm gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 1, 24, 48 and 72 hours then 7 and 14 days.
The general health of the animals was monitored at each observation point (24, 48, 72 h, and 7 and 14 days). Bodyweights were recorded pre-test and at termination. Scoring was done according to the Draize methodology.
Erythema scores, very slight to well defined at 1 hour following patch removal, ranged from absent to severe through Day 1 and cleared by Day 14. One animal had poor hair regrowth on Day 7, which cleared by Day 14. Edema scores generally ranged from absent to slight through Day 7 and cleared by Day 14, with the exception of a score 3 (moderate) in one animal at 24 hours. The primary dermal skin irritation index was equivalent to 3.67.
Under the test conditions, the test substance was considered to be irritating but not corrosive to skin.
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