Registration Dossier
Registration Dossier
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EC number: 941-237-8 | CAS number: -
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
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study performed according to GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 540/9-82-025
- Deviations:
- not specified
- GLP compliance:
- yes
- 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
- Molecular formula:
- ClH4N
- IUPAC Name:
- ammonium chloride
- Details on test material:
- Hoechst: white, crystalline, purity: 99.1%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pribright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- Animal: Pribright-White guinea pigs (Female)
About 8 weeks age, Mean weight; 240g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9% NaCl Solution
- Concentration / amount:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% NaCl Solution
- Concentration / amount:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
- No. of animals per dose:
- 20
- Details on study design:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
Day 1 : Intradermal induction exposure (Injection). The injection sites were not covered.
1-7: The application area was investigated.
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.
11 : Removal of the occlusive dressing. Recording of the irritation.
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.
23 : Removal of the occlusive dressing
24-25: Assessment of the skin - Challenge controls:
- no data
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Concentration:
- not applicable
- No. of animals per dose:
- not applicable
- Details on study design:
- not applicable
- Positive control substance(s):
- not specified
- Statistics:
- no data
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: induction
- Group:
- test chemical
- Clinical observations:
- very slight edema
- Remarks on result:
- other: Reading: other: induction. Group: test group. Clinical observations: very slight edema.
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: slight 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 animal s 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 Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not sensitizing for skin.
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