Registration Dossier
Registration Dossier
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EC number: 219-909-0 | CAS number: 2568-90-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 25. Sep 1968 - 03. Oct 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented report which meet sbasic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
- Principles of method if other than guideline:
- Method: BASF test
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,1'-[methylenebis(oxy)]dibutane
- EC Number:
- 219-909-0
- EC Name:
- 1,1'-[methylenebis(oxy)]dibutane
- Cas Number:
- 2568-90-3
- Molecular formula:
- C9H20O2
- IUPAC Name:
- 1,1'-[methylenebis(oxy)]dibutane
- Details on test material:
- - Name of test material (as cited in study report): Butylal; Formaldehyddibutylacetal
- Physical state: liquid
- Analytical purity: 98-99 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.56 kg and 2.98 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of the same animals served as control
- 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: 2.5x2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- ; 1 min and 5 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- erythema score
- Remarks:
- ; 15 min h exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- erythema score
- Remarks:
- ; 20 h exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days in 1/2 animals
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- edema score
- Remarks:
- ; 1 min and 5 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: after 8 days scaling was noted
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- edema score
- Remarks:
- ; 15 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- other: after 8 days scaling was noted
- Remarks on result:
- other: 72 h reading is missing
- Irritation parameter:
- edema score
- Remarks:
- ; 20 h exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: after 8 days scaling was noted
- Remarks on result:
- other: 72 h reading is missing
Any other information on results incl. tables
Mean erythema scores after (animal1/animal 2).
| Exposure time | same day | 24 h | 48 h | 72 h | 8 days | |||||||
| 1 min | 1/2 | 3/3 | 2/2 | -/- | 0/0 | |||||||
| 5 min | 2/2 | 3/3 | 2/2 | -/- | 0/0 | |||||||
| 15 min | 2/2 | 3/3 | 3/2 | -/- | 0/2 | |||||||
| 20 h | -/- | 3/3 | 3/2 | -/- | 0/2 |
Mean edema score after (animal1/animal 2).
| Exposure time | same day | 24 h | 48 h | 72 h | 8 days | |||||||
| 1 min | 0/0 | 0/0 | 0/0 | -/- | 0/0 | |||||||
| 5 min | 0/0 | 0/0 | 0/0 | -/- | 0/0 | |||||||
| 15 min | 0/0 | 2/2 | 2/0 | -/- | 0/0 | |||||||
| 20 h | -/- | 2/2 | 2/2 | -/- | 0/0 |
The original BASF grading was converted into the numerical grading according the OECD Draize system.
The application of the test substance for 1, 5, 15 min and 20 h let after 24 h to irritations, predominatly expressed by wide spanning, moderate erythema (1, 5, 15 min and 20 h exposure) and slight edema (15 min and 20 h exposure).
At the end of the observation period of 8 days slight erythema (15 min and 20 h exposure) was observed. Furthermore mild scaling was observed in one animal 8 days after 1, 5 and 15 min exposure time and in both animals 8 days after 20h exposure time.
Applicant's summary and conclusion
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