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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-122-2 | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Reaction mass of 2,6-dimethylpyridinium chloride and 3-methylpyridinium chloride and 4-methylpyridinium chloride
- EC Number:
- 941-122-2
- Molecular formula:
- not yet assigned
- IUPAC Name:
- Reaction mass of 2,6-dimethylpyridinium chloride and 3-methylpyridinium chloride and 4-methylpyridinium chloride
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adults
- Weight at study initiation: females <500 g
- Fasting period before study: overnight
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1st application: Induction 40 % occlusive epicutaneous
2nd application: Induction 40 % occlusive epicutaneous
3rd application: Induction 20 % occlusive epicutaneous
4th application: Challenge 10% occlusive epicutaneous
The maximum non-irritant concentration was determined in a pre-test.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1st application: Induction 40 % occlusive epicutaneous
2nd application: Induction 40 % occlusive epicutaneous
3rd application: Induction 20 % occlusive epicutaneous
4th application: Challenge 10% occlusive epicutaneous
The maximum non-irritant concentration was determined in a pre-test.
- No. of animals per dose:
- test group: 20
control group: 10 - Details on study design:
- Exposure time to test item: 6 hours each
Induction I, II and III: day 0, 7 and 14
Challenge: day 28
Reading: 30 and 54 h after the challenge application
Application volume: 0.3 cm3 - Challenge controls:
- A control group of 10 animals (females) was treated with adjuvant and the vehicle during the induction period.
For challenge the group was treated with the vehicle as well as the test material to check the maximum subirritant concentration of the material in adjuvant
treated animals. - Positive control substance(s):
- no
- Remarks:
- Not included in this test. However, strain sensitivity is checked periodically with known sensitizers.
Results and discussion
- Positive control results:
- Reference values with 2-Mercaptobenzothiazol (2-MCBT) (in life phase: 07-11-1994 to 02-12-1994):
Positive results in 9/10 animals after 48 h and 9/10 animals after 72 h.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- Erythema score up to 1, edema score up to 2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 10%. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Erythema score up to 1, edema score up to 2.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Erythema score up to 1, edema score up to 1
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Erythema score up to 1, edema score up to 1.
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- other: control vehicle
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: other: control vehicle. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- other: control vehicle
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: other: control vehicle. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- other: control test material
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: other: control test material. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- other: control test material
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: other: control test material. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
12/20 test animals showed a positive skin reaction.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this Bühler test the substance was sensitizing.
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.
