Registration Dossier

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:
2006
Bibliographic source:
OECD SIDS AMMONIUM CHLORIDE
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ammonium chloride
- Physical state: white, crystalline, purity
- Analytical purity: 99.1%

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 group
Dose level:
10%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Very slight to slight edema
Remarks on result:
other: Reading:

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