Ammonium sulphate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA 540/9-82-025

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The Guinea Pig Maximazitation Test met the previous requirements before the entry into force of REACH. The GPMT is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.

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

Molecular formula:

ClH4N

IUPAC Name:

ammonium chloride

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright-White

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: breeder
- Age at study initiation: about 8 weeks
- Mean weight at study initiation: 240 g

ENVIRONMENTAL CONDITIONS: not reported

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: 1st: intracutaneous, 2nd: occlusive epicutaneous

Vehicle:

other: 0.9% NaCl solution

Induction 2

Concentration / amount:

1st Induction: 5%, 2nd Induction 25 %, 3rd: Challenge: 10 %.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: 0.9% NaCl solution

Challenge 2

Concentration / amount:

1st Induction: 5%, 2nd Induction 25 %, 3rd: Challenge: 10 %.

No. of animals per dose:

20

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
1st application: Induction 5 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous

B. CHALLENGE EXPOSURE
3rd application: Challenge 10 % occlusive epicutaneous

METHOD
Day 1 : Intradermal induction exposure (Injection): The injection sites were not covered.
Day 1-7: The application area was investigated.
Day 9 : Dermal induction exposure: 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 for 48 hours.
Day 11 : Removal of the occlusive dressing. Recording of the irritation.
Day 22 : Dermal challenge exposure. 0.5ml of test substance preparation were applied to a cellulose patch and placed onto the clipped skin of the flank. An occlusive dressing with impermeable foil and an elastic bandage sealed the application site for 24 hours.
Day 23 : Removal of the occlusive dressing.
Day 24-25: Assessment of the skin.

Results and discussion

In vivo (non-LLNA)

Results

Key result

Reading:

other: 1st and 2nd reading

Group:

test chemical

Dose level:

ca. 76.5 mg

No. with + reactions:

2

Total no. in group:

20

Clinical observations:

24 and 48 hours after removal of the occlusive dressing, very slight, hardly perceptible erythema

Remarks on result:

other: see Remark

Remarks:

Reading: other: 1st and 2nd reading. Group: test group. Dose level: ca. 76.5 mg. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: 24 and 48 hours after removal of the occlusive dressing, very slight, hardly perceptible erythema .

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).