Registration Dossier
Registration Dossier
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EC number: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Apr 11th to May 22nd, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was perfomed in 2001. At the time there was no OECD guideline regarding LLNA method.
Test material
- Reference substance name:
- N,N-bis(2-hydroxypropyl)benzamide
- EC Number:
- 436-010-0
- EC Name:
- N,N-bis(2-hydroxypropyl)benzamide
- Cas Number:
- 422278-61-3
- Molecular formula:
- C13H19NO3
- IUPAC Name:
- N,N-bis(2-hydroxypropyl)benzamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PRIMID V 40-32
- Physical state: Solid
- Analytical purity: 96%
- Lot/batch No.: HSH 0015.1
- Expiration date of the lot/batch: March 31, 2003
- Storage condition of test material: At room temperature in the range 17-23 °C, away from direct sunlight
- Stability: Stable under storage conditions
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI (Himalayan spotted)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd Biotechnology and Animal Breeding Division, Wolferstrasse 4, CH-4414 Fullinsdorf/Switzerland
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 367-388 g
- Housing: Individually in makrolon type-4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3418, batch no. 33/00 and 90/01, guinea pig maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-14
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Remarks:
- selected on the basis of preliminary solubility testing
- Concentration / amount:
- Intradermal induction: 3% in corn oil
Epidermal induction: 50% in corn oil
Epidermal challenge: 15% in corn oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Remarks:
- selected on the basis of preliminary solubility testing
- Concentration / amount:
- Intradermal induction: 3% in corn oil
Epidermal induction: 50% in corn oil
Epidermal challenge: 15% in corn oil
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- All test animals (10) showed discrete/patchy to moderate/confluent erythema after the challenge treatment with 2-mercaptobenzothiazole at 1% (w/w) in mineral oil.
In vivo (non-LLNA)
Resultsopen allclose all
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 15% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: test group. Dose level: 15% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No toxic symptoms were evident in the guinea pigs of the test group.
Hence, the substance is not sensitizer. - Executive summary:
A Maximisation test was performed in accordance with OECD Guideline 406.
The intradermal induction of sensitization in the test group was perfomed in the nuchal region with a 3% dilution of the test item in corn oil and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50% in corn oil one week after the intradermal induction. The animals in the control group were intradermally induced with corn oil and FCA/physiological saline and epidermally induced with corn oil under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 15% in corn oil and corn oil alone under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
No toxic symptoms were evident in the guinea pigs of the control or the test group. No deaths occured. None of the control and test animals showed skin reactions after the challenge treatment with the substance at 15% in corn oil.
2 -mercaptobenzothiazole was used as positive control. All test animals (10) showed discrete/patchy to moderate/confluent erythema after the challenge treatment with 2-mercaptobenzothiazole at 1% (w/w) in mineral oil.
Based on these findings, the experiment was considered valid and the conclusion is that the substance is not sensitizer.
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