Registration Dossier
Registration Dossier
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EC number: 213-911-5 | CAS number: 1066-33-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well-documented publication which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- OECD SIDS Ammonium Chloride, Final 8/2006
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- OECD SIDS AMMONIUM CHLORIDE
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 540/9-82-025
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Hoechst AG
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- IUPAC Name:
- ammonium chloride
- Details on test material:
- - Name of test material (as cited in study report): Ammonium chloride
- Physical state: white, crystalline, purity
- Analytical purity: 99.1%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: ca.8 weeks
- Weight at study initiation: mean 240 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9% NaCl solution
- Concentration / amount:
- - Intracutanous induction: 5 %
- epicutanous induction: 25 %
- challenge: 10 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% NaCl solution
- Concentration / amount:
- - Intracutanous induction: 5 %
- epicutanous induction: 25 %
- challenge: 10 %
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal and 1 epicutanous induction
- Exposure period: 48 h (epicutanous induction)
- Test groups: 20 animals
- Duration: intradermal induction on day 1 with daily obervation of test sites until day 7; on day 9 epicutanous induction
- Patch: 0.5ml of the test substance preparation were applied to a cellulose patch of 2x4 cm. This patch covered the area of the intradermal injection sites. An occlusive dressing with impermeable foil and an elastic bandage sealed the application site
- Concentrations: 5% (Intracutanous induction), 25% (epicutanous induction)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: 20
- Site: clipped skin of flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24, 48 h
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: readings
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Very slight to slight edema
- Remarks on result:
- other: Reading: other: readings. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Very slight to slight edema.
Any other information on results incl. tables
1) The treated animals did not show any signs of toxicity throughout the
study period.
2) Induction: Very slight to slight edema were observed in the treatment
group.
3) Challenge: 24 and 48 hours after removal of the occlusive dressing, a
total of 2 animals (in 20) of the treatment group showed very slight,
hardly perceptible erythema.
Ten percent of the animals of treatment group demonstrated a positive
reaction after the challenge exposure (the criteria: the limit value of
30 percent).
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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