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EC number: 229-761-9 | CAS number: 6711-48-4
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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Endpoint summary
Administrative data
Description of key information
In a guinea pig maximization test according to EU method B.6, the test substance was observed not to be sensitising to the skin (BASF AG, 1993). No in vitro skin sensitization studies were performed.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.6
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this test was performed before entry into force of the REACH Regulation.
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Bis-(3-dimethylaminopropyl)-amin
- Physical state: liquid, slight yellowish
- Analytical purity: 98.5 %
- Lot/batch No.: 19b/KW 23857369582-8
- Storage: room temperature - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 292 - 341 g
- Housing: 5 animals per cage
- Diet: Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet), ad libitum
- Water: tap water ad libitum (about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week).
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
The feed used in the study was assayed for chemical and microbiological contaminants. The dinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF AG as well as for the presence of germs by a contract laboratory.
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 0.1 % in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) or 0.9% aqueous NaCl-solution.
Percutaneous induction: test substance 1 % in aqua bidest.
Challenge: test substance 0.5 % in aqua bidest.
(concentrations were selected on the basis of a pretest) - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 0.1 % in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) or 0.9% aqueous NaCl-solution.
Percutaneous induction: test substance 1 % in aqua bidest.
Challenge: test substance 0.5 % in aqua bidest.
(concentrations were selected on the basis of a pretest) - No. of animals per dose:
- Test group: 10
Control groups: 5/group (2 control group) - Details on study design:
- RANGE FINDING TESTS:
2 x 2 cm filter paper strips soaked in the test substance formulation (about 0.15 g) were applied to the skin of the flanks under an occlusive dressing. The test substance was applied 2 times for 24 h within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitisation reaction but could possibly be attributed to a shift in the irritation threshold.
- Site of application: flank
- No. of animals: 4 per test concentration
- Readings: about 24 and 48 h after the beginning of application
- Evaluation: according to the Draize Scoring System
MAIN STUDY
A. 1) INDUCTION EXPOSURE (intradermal)
- No. of exposures: 6 intradermal injections in groups of two per animal
- Test group (10 animals): front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1:1; middle row: 2 injections each of 0.1 mL of the test substance formulation; back row: 2 injections each of 0.1 mL Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) with test substance
- Control groups (5 animals per group): The animals were given the same injections but without test substance, only with the formulating agent
- Site: shoulder
- Readings: 24 h after the beginning of application
- Evaluation: according to the Draize Scoring System
2) INDUCTION EXPOSURE (percutaneous)
- No. of exposures: 1 percutaneous exposure 1 week after intradermal induction
- Amount applied: 2 x 4 cm filter paper strips soaked in the test substance formulation (about 0.3 g) were applied to the skin of the shoulder under an occlusive dressing
- Exposure period: percutaneous exposure: 48 h
- Control groups: no treatment
- Site of application: shoulder, same area as intradermal application
- Readings: 24 h after the beginning of application
- Evaluation: according to the Draize Scoring System
B. CHALLENGE EXPOSURE
- No. of exposures: single percutaneous exposure
- Duration of exposure: 24 h
- Day of challenge: 21 days after intradermal induction
- Site: intact flank
- Concentrations: non-irritant concentration (2 x 2 cm filter paper strips soaked with about 0.15 g of the test substance formulation)
- Control groups: control group 1 treated like test group; control group 2 remained untreated
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch
- Site of application: intact flank - Positive control substance(s):
- yes
- Remarks:
- Performed in a separate study twice a year in the laboratory with alpha-hexylcinnamaldehyde.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, the test substance is considered not sensitizing to the skin and is not to be classified according to the criteria laid down in the CLP regulation.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
The intradermal induction with 0.1% test substance preparations caused well-defined erythema and slight edema were observed at the injection sites of the control group animals and test group animals. The control group animals which were treated with 0.9% aqueous NaCl-solution did not show any skin reactions.
After the percutaneous induction with a 1% test substance preparation incrustation, partially open (caused by the intradermal induction) could be observed in addition to well-defined erythema and slight edema in all test group animals.
After the challenge with a 0.5 % test substance preparation the animals of control group and the test group, animals did not show any skin reactions 24 and 48 hours after removal of the patches.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
BASF AG (1993) investigated the sensitising properties of the test substance in a guinea pig maximisation test with male and female Dunkin-Hartley guinea pigs. The study examined the skin sensitising effect on guinea pigs, using 20 animals in total. Positive and negative controls were included in the study. Animals were induced with 0.1% (intradermal induction) and 1% (percutaneous induction) and challenged with 0.5% the test substance. Based upon the observations made in the assay, the substance didn’t cause skin sensitisation in guinea pigs.
No in vitro skin sensitization studies were performed, as the key in vivo study was performed before the guideline was enforced in Oct 2016.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study results and the criteria of the CLP Regulation, the test substance should not be classified as skin sensitising substance.
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