Registration Dossier
Registration Dossier
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EC number: 204-661-8 | CAS number: 123-91-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- study was conducted before OECD 404 TG was established
- Principles of method if other than guideline:
- BASF Test
Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test). Two white Vienna rabbits were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. - GLP compliance:
- no
Test material
- Reference substance name:
- 1,4-dioxane
- EC Number:
- 204-661-8
- EC Name:
- 1,4-dioxane
- Cas Number:
- 123-91-1
- Molecular formula:
- C4H8O2
- IUPAC Name:
- 1,4-dioxane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Weight at study initiation: male 3.11 kg; female 3.18 kg
ENVIRONMENTAL CONDITIONS
no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: approx. 1 mL - Duration of treatment / exposure:
- 1, 5, 15 min and 20 h
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch, no further data
REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %); no (exposure 20 h)
- Time after start of exposure: 1, 5, and 15 min, respectively
SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Exposure time: 15 min
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: desquamation, parchment-like necrosis
- Irritation parameter:
- edema score
- Remarks:
- Exposure time: 15 min
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Remarks:
- Exposure time: 20 h
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 1.34
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: desquamation, parchment-like necrosis
- Irritation parameter:
- edema score
- Remarks:
- Exposure time: 20 h
- Basis:
- mean
- Remarks:
- (2 animals)
- Time point:
- 24/48/72 h
- Score:
- 0.84
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
Table 1 Mean erythema score after 24, 48 and 72 h (2 animals)
Exposure time |
24 h |
48 h |
72 h |
mean |
1 min |
1/1 |
0/1 |
0/1 |
0.33/1 |
5 min |
0/1 |
0/1 |
0/1 |
0/1 |
15 min |
0/2* |
0/2** |
0/2** |
0/2 |
20 h |
1/2* |
0/2* |
1/2 |
0.67/2 |
* brownish
** parchment-like
*** leather-like necrosis
Table 2 Mean edema score after 24, 48 and 72 h (2 animals)
Exposure time |
24 h |
48 h |
72 h |
mean |
1 min |
0/0 |
0/0 |
0/0 |
0/0 |
5 min |
0/0 |
0/0 |
0/0 |
0/0 |
15 min |
0/0 |
0/0 |
0/0 |
0/0 |
20 h |
0/2 |
0/3 |
0/0 |
0/1.67 |
Table 3 Findings after 8 days (2 animals)
Exposure time |
Skin finding |
1 min |
no skin findings*/desquamation |
5 min |
no skin findings*/desquamation |
15 min |
no skin findings*/desquamation, parchment-like necrosis fallen off |
20 h |
no skin findings*/desquamation, parchment-like necrosis |
*transient desquamation observed 6 days after application
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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