Registration Dossier
Registration Dossier
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EC number: 203-149-1 | CAS number: 103-83-3
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: Guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: EG-Richtlinie 84/449: Einstufung, Verpackung und Kennzeichnung gefährlicher Stoffe, "Akute Toxizität-Sensibilisierung der Haut" [8].
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted/reported in the year 1993. At this time no valid guideline for a LLNA was available.
Test material
- Reference substance name:
- Benzyldimethylamine
- EC Number:
- 203-149-1
- EC Name:
- Benzyldimethylamine
- Cas Number:
- 103-83-3
- Molecular formula:
- C9H13N
- IUPAC Name:
- benzyldimethylamine
- Details on test material:
- TS-Freetext:
Purity: 99.5 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 334 g (295-386 g)
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 40-70
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 2% Cremophor EL in saline
- Concentration / amount:
- Induction:
1st application: 2.5 % intracutaneous
2nd application: I2 % occlusive epicutaneous
Challenge
3 %,, occlusive, epicutaneous
6 % , occlusive, epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 2% Cremophor EL in saline
- Concentration / amount:
- Induction:
1st application: 2.5 % intracutaneous
2nd application: I2 % occlusive epicutaneous
Challenge
3 %,, occlusive, epicutaneous
6 % , occlusive, epicutaneous
- No. of animals per dose:
- 10 (control groups); 20 (test substance groups)
- Details on study design:
- according to OECD TG 406
- Challenge controls:
- yes: vehicle
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Group:
- positive control
- Remarks on result:
- other: The validity of the Maximization Test according to Magnussen and Kligman is regularly tested:
- Remarks:
- Alpha-cinnamic aldehyde: Bayer Report no. 21251 (Dreist 1992); 2-mercaptobenzothiazole: Bayer Report no. 21367 (Dreist 1992), 4-aminobenzoeicacid ethylester: Bayer Report no. 21368 (Dreist 1992).
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
In a Guinea PigMaximization Test according to OECD TG 400 (Magnusson and Klingman) male guinea pigs were tested with following concentrations of the test substance:
1st application: Induction 2.5 % intracutaneous
2nd application: Induction 12 % occlusive epicutaneous
3rd application: Challenge 6 % and 3% occlusive epicutaneous
The test substance was formulated as an emulsion with Cremophor EL in sterile physiological saline solution (2% V/V).
No skin reddening was observed after the provocation with 6% and 3% of test substance neither in the test animals nor in the control animals. The test substance therefore shows no skin sensitating potential (Bayer AG 1993).
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