Registration Dossier
Registration Dossier
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EC number: 257-440-3 | CAS number: 51812-80-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 5 - August 10, 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Essentially similar to the Buehler test.
- Deviations:
- yes
- Remarks:
- Number of animals < 20 and multiple injections instead of only one.
- Principles of method if other than guideline:
- Landsteiner and Jacobs Guinea Pigs Sensitization Procedure
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study is performed before introduction of the LLNA method as a sensitization study.
Test material
- Reference substance name:
- 3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride
- EC Number:
- 257-440-3
- EC Name:
- 3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride
- Cas Number:
- 51812-80-7
- Molecular formula:
- C13H29N2O7.Cl
- IUPAC Name:
- 1-Propanaminium, 3-(D-gluconoylamino)-N-(2-hydroxyethyl)-N,N-dimethyl-, chloride
1
- Specific details on test material used for the study:
- Not specified
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- A group of 10 white male guinea pigs weighing300-500 grams were identified and housed individually.
The hair was removed from their backs with an electric clipper prior to initiation of study and whenever necessary throughout the study.
They subsisted on commercial rabbit pellets, greens, carrots and water.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% solution
- Day(s)/duration:
- Injections were performed three times weekly, until a total of ten had been made.
- Adequacy of induction:
- not specified
Challenge
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% solution
- Day(s)/duration:
- Two weeks ajter the tenth injection, a challenge (re-test) injection was performed, using 0.05 ml. of a freshly prepared solution or suspension.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: three weeks
- Test groups: 1
- Control group: no
- Site: at random in the shaved back areas
- Frequency of applications: three times weekly
- Concentrations: 0.1 % solution
- Evaluation (hr after injection): 24 h
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks ajter the tenth injection
- Site: The eleventh (re-test) injection was made just below the region of the ten sensitizing injections.
- Evaluation (hr after challenge): 24 h - Challenge controls:
- Not included
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- Not included
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Average of Ten Sensitizing injections
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1) The test material, when intra-cutaneously injected produced scores identical to that of the control (distilled water).
2) On the challenge (re-test) injection, none of the test animals exhibited reactions higher than the average of the original scores.
3} The test material is considered to be a non-sensitizer (score 0. 0).
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