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EC number: 229-194-7 | CAS number: 6425-39-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-dimorpholinyldiethyl ether
- EC Number:
- 229-194-7
- EC Name:
- 2,2'-dimorpholinyldiethyl ether
- Cas Number:
- 6425-39-4
- Molecular formula:
- C12H24N2O3
- IUPAC Name:
- 4-{2-[2-(morpholin-4-yl)ethoxy]ethyl}morpholine
- Test material form:
- liquid
- Details on test material:
- - State of aggregation : liquid
- Appearance : colourless to yellow brown
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: H 50541 H x B (Substance number: 95/452)
- Analytical purity: 98.4%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, exclusion of oxygen (under nitrogen)
OTHER SPECIFICS:
- Name of test substance (as cited in study report): 2,2'-Dimorpholinodiethylether
- Physical state: liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Weight at study initiation: 2.2 kg and 2.51 kg (males); 2.53 (female)
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet: Kliba-Labordiaet 341, Klingenthalmuehle AG, Kaiseraugust, Switzerland (about 130 g/animal/day)
- Water: about 250 mL per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of the unchanged test substance - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days (reading was performed 1 h, 24 h, 48 h, 72 h and 8 d after application)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol conc. and Lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM: evaluation according to the Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scaling at 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (3 animals)
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Irritant response data:
Reading |
Animal |
Erythema |
Edema |
Symptoms |
1 h |
1 |
2 |
0 |
E |
2 |
2 |
0 |
E |
|
3 |
2 |
0 |
E |
|
24 h |
1 |
2 |
0 |
E |
2 |
2 |
0 |
E |
|
3 |
2 |
0 |
E |
|
48 h |
1 |
2 |
0 |
E |
2 |
2 |
0 |
E |
|
3 |
2 |
0 |
|
|
72 h |
1 |
1 |
0 |
S |
2 |
2 |
0 |
E |
|
3 |
2 |
0 |
|
|
8 d |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
Mean (24 h, 48 h, 72 h) |
1 |
1.7 |
0.0 |
|
2 |
2.0 |
0.0 |
|
|
3 |
2.0 |
0.0 |
|
|
Mean |
(1, 2 and 3) |
1.9 |
0.0 |
|
E: Erythema extending beyond the area of exposure
S: Scaling
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritation potential of the substance in New Zealand White rabbits was investigated according to OECD Guideline 404 and EU Method B.4. Based on the test results and according to the criteria of the DSD and CLP Regulation, the substance should not be classified as irritating to the skin.
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