Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-276-1 | CAS number: -
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:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methylenediphenyl diisocyanate
- EC Number:
- 247-714-0
- EC Name:
- Methylenediphenyl diisocyanate
- Cas Number:
- 26447-40-5
- IUPAC Name:
- 1,1'-methylenebis(2-isocyanatobenzene)
- Reference substance name:
- benzene, 1,1'-methylenebis[isocyanato
- IUPAC Name:
- benzene, 1,1'-methylenebis[isocyanato
- Details on test material:
- - Name of test material (as cited in study report): Desmodur VP.PU 1806
- Physical state: colorless, clear liquid
- Analytical purity: see composition of test material
- Composition of test material, percentage of components: 2,2'-Diisocyanatodiphenylmethane 0.64%, 2,4'-Diisocyanatodiphenylmethane 53.60% and 4,4'-Diisocyanatodiphenylmethane 45.72%.
- Manufacturer: Bayer AG, Liverkusen
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: room temperature, in nitrogen
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfaune UK Ltd.
- Mean body weight at study initiation: 3.52 Kg (3.1 - 3.7 Kg)
- Diet (e.g. ad libitum): Standard diet "Ssniff", approx. 100-120 g per animal/day, once per day in the morning
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6x6
REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 2.03
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 1.43
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24-48-72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24-48-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24-48-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- The reactions extended beyond the exposed area. Eschar formation was observed in 1 animal from 72 h to 7 days and in 2 animals on day 7. The exposed site was covered by a whitish scaly layer in 2 animals after 7 days and in 2 additional animals on day 14.
Any other information on results incl. tables
Animal No. |
DRAIZE grade after |
Mean (24-48-72 h) |
||||||||||||
1h |
24h |
48h |
72h |
7days |
14days |
|||||||||
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
|
1 |
1 |
0 |
2 |
0 |
2 |
0 |
2 |
0 |
2 |
3 |
0 |
0 |
2.0 |
0.0 |
2 |
1 |
0 |
2 |
0 |
1 |
0 |
1 |
0 |
2 |
2 |
2 |
0 |
1.3 |
0.0 |
3 |
1 |
0 |
2 |
0 |
1 |
0 |
1 |
0 |
3 |
3 |
2 |
0 |
1.3 |
0.0 |
4 |
1 |
0 |
2 |
2 |
2 |
3 |
4 |
3 |
4 |
4 |
2 |
2 |
2.7 |
2.7 |
5 |
0 |
0 |
2 |
2 |
2 |
3 |
3 |
4 |
4 |
4 |
3 |
2 |
2.3 |
3.0 |
6 |
0 |
0 |
2 |
2 |
3 |
3 |
3 |
4 |
4 |
4 |
3 |
2 |
2.7 |
3.0 |
Mean |
0.7 |
0.0 |
2.0 |
1.0 |
1.8 |
1.5 |
2.3 |
1.8 |
3.2 |
3.3 |
2.0 |
1.0 |
||
Mean of 6 animals (24-48-72 h) |
E = 2.03 |
O = 1.43 |
||||||||||||
E: erythema and eschar formation
O: oedema formation
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
