Registration Dossier
Registration Dossier
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EC number: 235-186-4 | CAS number: 12125-02-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 540/9-82-025
- Version / remarks:
- November 1982, revised at November 1984
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Another internationally accepted test method was used.
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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White (Hoe: DHPK (SPFLac))
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: about 8 weeks
- Mean weight at study initiation: within 20 % of mean weight (Range = -13 % to + 10 %), n = 30
- Housing: 5/cage in Type 4 Macrolon cages
- Diet: ad libitum; "ERKA-Mischfutter Nr. 8300 fuer Meerschweinchen und Kaninchen"
- Water: ad libitum; tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and epicutaneous (occlusive)
- Vehicle:
- physiological saline
- Remarks:
- (0.9%)
- Concentration / amount:
- - 1st Induction: 5%
- Epicutaneous Induction 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Remarks:
- (0.9%)
- Concentration / amount:
- - Challenge: 10 %.
- No. of animals per dose:
- - Treatment group: 20
- Control group: 10
- Satellte group: 5 - Details on study design:
- JUSTIFICATION FOR CHOICE OF CONCENTRATIONS
- Based on results of range finding test (see below)
RANGE FINDING TESTS (RFT):
Intradermal injection
- No. of animals: 3 females/concentration
- Site/Area: back/2 x 4 cm
- Concentrations: 0.2, 1.0 and 5.%
- Vehicle: physiol. saline (0.9 %)
- Volume injected: 0.1 mL
- Number of injection/concentration: 2
- Evaluation (hr after injection): 24 hour post injection
RANGE FINDING TESTS (RFT):
Epicutanous application
- Rationale: determine the highest concentration of the test substance that causes slight to moderate irritation and for the challenge the maximum non-irritant concentration
- No. of animals: 2 females/test concentration
- Site: left flank
- Area of exposure: 2 x 2 cm
- Type of coverage: occlusive
- Concentrations: 1.0, 10.0 and 25% (25% is technically the maximal achievable concentration)
- Vehicle: physiol. saline (0.9%)
- Volume applied: 0.5 mL applied on a test patch
- Duration: 24 hours
- Evaluation (hr after challenge): 24 hours
MAIN STUDY
A INDUCTION EXPOSURE
Intradermal Injection
- Site/Area: Back (near the shoulders) /2 x 4 cm
- No. of injections/animal: 6 injections
- Test substance group (cranial; 2 injections side by side): 50 % Freund's complete adjuvant (FCA) blended (1:1, v/v) with physio. saline (0.9 %)
- Test substance group (middle; 2 injections side by side): The test article (5 %) in vehicle
- Test substance group (caudal; 2 injections side by side): 50 % Freund's complete adjuvant blended (1:1, v/v) with physio. saline (0.9 %) and 5% test article
- Control group (cranial; 2 injections side by side): 50 % Freund's complete adjuvant (FCA) blended (1:1, v/v) with physio. saline (0.9 %)
- Control group (middle; 2 injections side by side): Vehicle
- Control group (caudal; 2 injections side by side): 50 % Freund's complete adjuvant (FCA) blended (1:1, v/v) with physio. saline (0.9 %)
- Volume per injection: 0.1 mL
- Evaluation (hr after injection): from 24 hour till day 7
Epicutaneous induction exposure
- Time schedule: 8 days after intradermal injection
- Site: same as intradermal injection
- Area of application: 2 x 4 cm (cellulose patches)
- Concentrations: 25 % (test group), 0.9 % Physiol. Saline (control group)
- Volume applied: 0.5 mL/animal
- Type of coverage: occlusive (impemeable foil with adhesive fleece)
- Duration: 48 hours
- Evaluation (hr after challenge): directly after removal of patch
B. CHALLENGE EXPOSURE (all animals)
- Time schedule: 13 days after termination of induction exposures
- Site: left flank
- Area of application: 2 x 2 cm (cellulose patches)
- Concentrations: undiluted
- Volume applied: 0.5 mL/animal
- Type of coverage: occlusive (impemeable foil with adhesive fleece)
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure
SCORING SYSTEM: OECD Draize system - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs of toxicity. Skin indicated very slight, hardly perceptible erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs of toxicity. Skin indicated very slight, hardly perceptible erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs of toxicity
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs of toxicity
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
RANGE FINDING TESTS (RFT):
Intradermal injection:
0.2 % and 1.0 % of the test substance formulation caused slight edema at the injection sites. 5.0 % of the test substance formulation caused slight erythema and edema at the injection sites. 5.0 % was used in the main study based on the findings decribed above.
Epicutaneous induction:
No effects were seen after dermal application of the test substance formulations (1.0, 10.0, and 25.0 % in physiol. Saline (0.9 %). A maximal non-irritating concentration of 25.0 % is thus attained. However, in combination with Freud’s adjuvant, the maximal non irritating concentration can be reduced. For this reason, the satellite animals (5 animals) which had been pretreated with Freud’s adjuvant were exposed to 25.0 %. The treated skin of 3 of the 5 animals exhibited very slight erythema. In addition, the skin at the application site was dry, cracked and scaly. Based on this finding, the maximal non irritating concentration was set at 10.0 % for them main study.
MAIN STUDY
Clinical signs of toxicity
The treated animals displayed no signs of intoxication through out the entire study duration
Induction
Intradermal injection with Freud’s adjuvant (with and without the testsubstance) led in the control and the treated animals as well as in animals of the preliminary dose finding experiment to well defined erythema and slight edema. Very slight to slight edema appeared at the application sites injected with the test substance in physiol. Saline (0.9 %). In addition scab formation was noted in all animals. The body weight gain of treated animals was not affected.
Challenge:
Only two of ten animals (10.0 %) treated with the test substance formulation had a positive reation. A very slight barely noticeable erythema was seen at the application sites of these animals. The remaining animals showed no irritation effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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