Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 217-101-2 | CAS number: 1739-84-0
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- prior to the adoption of OECD404 in 1981
- Principles of method if other than guideline:
- Three test groups of animals were treated for 4 hour, 1 hour an 3 minutes respectively using occlusive conditions. An application site of 2x2 cm was covered with the liquid test substance. After the application time (4 h) the skin was washed with Lutrol or water/Lutrol mixture (1:1). The animals were observed for 8 days and skin changes were recorded. The report describes findings after 4, 24 and 48 hours and at the end of the observation period (8 days).
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,2-dimethylimidazole
- EC Number:
- 217-101-2
- EC Name:
- 1,2-dimethylimidazole
- Cas Number:
- 1739-84-0
- Molecular formula:
- C5H8N2
- IUPAC Name:
- 1,2-dimethyl-1H-imidazole
- Details on test material:
- - Name of test material (as cited in study report): 1,2-Dimethylimidazol
- Substance no.: 79/636
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: M.GAUKLER (6050 Offenbach)
- Weight at study initiation: 4hr test: 3.4 kg, 1hr test: 3.3 kg, 3 minut test: 2.9 kg
- Diet: Ssniff K, standard diet for rabbits and guinea pigs (Firma INTERMAST GMBH, Soest), ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 80% aqueous preparation - Duration of treatment / exposure:
- 4 hours, 1 hour and, 3 minutes
- Observation period:
- 8 days
- Number of animals:
- 4 hour test: 3 male and 3 female
1 hour test: 1 male and 1 female
3 minute test: 1 male and 1 female - Details on study design:
- Approximately 15-24 hours before treatment, the backs and sides of the animals were shaved with an electric clipper. On test day 1, a skin area of approx 2 x 2 cm was exposed for 4 hours, 1 hour and 3 minutes using a patch holding the chemical. During exposure the test areas were covered with inert foil and fixed with adhesive bandage. In the 3 minute exposure test the test patches were held manually against the animals. After exposure the treated skin was washed with Lutrol or a water/Lutrol mixture (1:1) and dried with cellulose towels.
TEST SITE
- Area of exposure: 2 x 2 cm
- Type of wrap: rubberised linnencloth, fixed with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (50% or 100%) and dried with cellulose
- Time after start of exposure: up to 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: necrosis observed
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: necrosis observed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: necrosis observed
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: necrosis observed
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: patchy superficial necrosis and scale formation
- Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- 1 h exposure
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- 1 h exposure
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Remarks:
- animal 1-2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scale formation in one animal on day 8
Applicant's summary and conclusion
- Interpretation of results:
- other: skin irritating
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.
