Ammonium hydrogencarbonate

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

Reference

Reference 1

Reference Type:

publication

Title:

OECD SIDS Ammonium Chloride, Final 8/2006

Author:

OECD

Year:

2006

Bibliographic source:

OECD SIDS AMMONIUM CHLORIDE

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1986

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

Test material information

Constituent 1

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%

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)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: 0.9% NaCl solution

Induction 2

Concentration / amount:

- Intracutanous induction: 5 %
- epicutanous induction: 25 %
- challenge: 10 %

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: 0.9% NaCl solution

Challenge 2

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