Registration Dossier
Registration Dossier
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EC number: 204-137-9 | CAS number: 116-37-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not indicated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in 1975, non-GLP, but appropriate for this endpoint.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Patch-test technique on the intact and abraded skin of albino rabbits.
- GLP compliance:
- no
- Remarks:
- test was performed before GLP principles were in place.
Test material
- Reference substance name:
- 1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol
- EC Number:
- 204-137-9
- EC Name:
- 1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol
- Cas Number:
- 116-37-0
- Molecular formula:
- C21H28O4
- IUPAC Name:
- 1-(4-{2-[4-(2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propan-2-ol
- Details on test material:
- CAS number : 116-37-0
EC number : 204-137-9
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved or shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 12
- Details on study design:
- TEST SITE
- Area of exposure: not indicated
- % coverage: 1 inch x 1 inch
- Type of wrap if used: impervious tape to retard evaporation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: at 24h and 48 hours later (72 hours after application)
SCORING SYSTEM:Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean of erythema and edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.8
- Max. score:
- 2
- Remarks on result:
- other: intact skin; edema score is 0 in all animals
- Irritation parameter:
- other: probably mean of erythema and edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 1
- Remarks on result:
- other: intact skin
- Irritation parameter:
- other: mean of erythema and edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.8
- Max. score:
- 2
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- other: probably mean of erythema and edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- The available in vivo test on skin irritation for Dianol 33 is not according to current guidelines. Exposure was during 24 h on intact and abraded skin under occlusion. See included table for results.
Any other information on results incl. tables
Intact skin |
Abraded skin |
||||||
Rabbit nr |
24h erythema |
24h edema |
72h |
Rabbit nr |
24h erythema |
24h edema |
72h |
1 |
0 |
0 |
0 |
7 |
2 |
0 |
1 |
2 |
0 |
0 |
1 |
8 |
2 |
1 |
1 |
3 |
1 |
0 |
0 |
9 |
1 |
0 |
1 |
4 |
1 |
0 |
1 |
10 |
1 |
0 |
1 |
5 |
2 |
0 |
0 |
11 |
2 |
0 |
1 |
6 |
1 |
0 |
1 |
12 |
2 |
0 |
1 |
average |
0.8 |
0.7 |
|
1.8 |
1.0 |
||
24 h reading is directly after removal of the patches (with 24 h exposure), 72 h reading is 48 hours after first reading.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not skin irritating.
- Conclusions:
- Dermal exposure of Dianol 33 was tested during 24h under occlusive conditions on both intact and abraded skin. Although this study was not performed according to current guidelines, the exposure conditions are more worst case than required by guidelines and are considered acceptable for conclusion on skin irritating properties of Dianol 33. Based on the observed slight irritation of exposed abraded skin after 24h of exposure, which effect was decreased after another 48h (mean score is 1 at 72h ), Dianol 33 does not have to be classified and has no obligatory labelling requirement for dermal irritation according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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