Reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study (Adopted according to OECD SIDS)

Data source

Reference

Reference Type:

secondary source

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

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 (Hoechst)
- Physical state: crystalline
- Analytical purity: 99.1%
- Other: white

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

Reading:

other: 1st and 2nd reading

Hours after challenge:

24

Group:

test chemical

Dose level:

ca. 76.5 mg (10%)

No. with + reactions:

2

Total no. in group:

20

Clinical observations:

No signs of toxicity; 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. . Hours after challenge: 24.0. Group: test group. Dose level: ca. 76.5 mg (10%). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: No signs of toxicity; 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).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information