Registration Dossier
Registration Dossier
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EC number: 224-207-2 | CAS number: 4246-51-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- short exposure period (3 min and 1 hour); occlusive coverage; short observation period (72 hours); non-GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Principles of method if other than guideline:
- BASF-test (short-term test): The undiluted test substance was applied 3 min and 1 h to the intact rabbit skin under an occlusive dressing. Scoring according to Draize was carried out after patch removal and after 24, 48 and 72 h.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,3'-oxybis(ethyleneoxy)bis(propylamine)
- EC Number:
- 224-207-2
- EC Name:
- 3,3'-oxybis(ethyleneoxy)bis(propylamine)
- Cas Number:
- 4246-51-9
- Molecular formula:
- C10H24N2O3
- IUPAC Name:
- 3,3'-[oxybis(ethane-2,1-diyloxy)]dipropan-1-amine
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4,7,10-Trioxatridecan-1,13-diamin
- Physical state/appearance: yellowish liquid
- Purity: min 95%
- Expiration date of the lot/batch: July 1985
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Weight at study initiation: mean males 2.69 kg
- Housing: single housing in stainless steel cages (floor area 40 cm x 51 cm)
- Diet: ca. 130 g Ovator Solikanin 4 mm (Muskator-Werke, Düsseldorf, FRG) per animal per day
- Water: ca. 250 mL tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: ca. 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm skin area on the upper third of the back or flank
- Type of wrap if used: not specified
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (concentrated) and Lutrol/water (1:1)
- Time after start of exposure: 3 minutes or 1 hour
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 3 minutes occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 3 minutes occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 1 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 1 hour occlusive exposure
- Irritant / corrosive response data:
- 3 min exposure: erythema of max. grade 2, not fully reversible within the 72-h observation period; edema of grade 1 in one animal, fully reversible within 48 h
1 h exposure: comprehensive erythema and edema; necrosis in all animals from 24 h after application of the TS onwards, full-thickness necrosis in all animals 72 h after application of the TS, finding macroscopic-pathologically confirmed 72 h after application of the TS
Any other information on results incl. tables
Table 1: Irritation scores:
Timepoint |
Animal No. |
Intact skin |
Symptoms |
|
Erythema |
Edema |
|||
3 minutes exposure, occlusive |
||||
3 min |
1 |
1 |
0 |
|
2 |
1 |
1 |
|
|
3 |
1 |
0 |
|
|
24 h |
1 |
0 |
0 |
|
2 |
2 |
1 |
|
|
3 |
1 |
0 |
|
|
48 h |
1 |
0 |
0 |
|
2 |
2 |
0 |
|
|
3 |
0 |
0 |
|
|
72 h |
1 |
0 |
0 |
|
2 |
2 |
0 |
|
|
3 |
0 |
0 |
|
|
Mean 24, 48, 72 h |
1 |
0 |
0 |
|
Mean 24, 48, 72 h |
2 |
2 |
0.3 |
|
Mean 24, 48, 72 h |
3 |
0.3 |
0 |
|
Mean 24, 48, 72 h |
1, 2, 3 |
0.8 |
0.1 |
|
|
||||
1 hour exposure, occlusive |
||||
1 h |
1 |
2 |
3 |
Overlapping erythema and edema, haemorrhagic |
|
2 |
3 |
2 |
|
|
3 |
3 |
3 |
|
24 h |
1 |
4 |
2 |
Necrosis, overlapping edema |
|
2 |
4 |
2 |
|
|
3 |
4 |
2 |
|
48 h |
1 |
4 |
2 |
Necrosis, overlapping edema |
|
2 |
4 |
2 |
|
|
3 |
4 |
2 |
|
72 h |
1 |
4 |
2 |
Necrosis, overlapping edema, full-thickness necrosis macroscopic-pathologically confirmed |
|
2 |
4 |
1 |
|
|
3 |
4 |
2 |
|
Mean 24, 48, 72 h |
1 |
4 |
2 |
|
Mean 24, 48, 72 h |
2 |
4 |
1.7 |
|
Mean 24, 48, 72 h |
3 |
4 |
2 |
|
Mean 24, 48, 72 h |
1, 2, 3 |
4 |
1.9 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- A 1-hour occlusive treatment with the unchanged test substanced caused skin corrosion in rabbits.
- Executive summary:
In this short-term test (non-GLP, reliability 2), the undiluted test substance was applied 3 min and 1 h to the intact rabbit skin (3 males, Vienna White) under an occlusive dressing. After exposure, the substance was washed with with Lutrol (concentrated) and Lutrol/water (1:1). Scoring according to Draize was carried out after patch removal and after 24, 48 and 72 h. An exposure duration of 3 min caused erythema of max. grade 2 (not fully reversible) and edema of grade 1 in one animal (fully reversible within 48 h). Extension of the exposure time provoked severe skin reactions. After 1 h of treatment, comprehensive erythema and edema, as well as necrosis was observed in all animals from 24 h after application of the test substance onwards. A full-thickness necrosis in all animals was macroscopic-pathologically confirmed at the end of the study.
Based on this study finding, the test substance is corossive (Cat. 1B) to the skin.
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