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EC number: 235-186-4 | CAS number: 12125-02-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
In a skin irritation study in rabbits, according to the guideline of the Federal Register, Vol.43, No. 163 (Microbiological and Biochemical Assay Laboratories,1985), the test item did not show skin irritating properties.
In an eye irritation study comparable to OECD guideline 405 (BASF SE, 1968), the test item showed eye irritating properties.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Reliability adopted from OECD SIDS document - Meets generally accepted scientific standards and acceptable for assessmnet (original literature not available)
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register, vol.43, no 163
- Version / remarks:
- 1978-08-22
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot No.of test material: 50820 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rich-Glo-farms (U.S.D.A. 74-AA-29), El Campo, Texas USA
- Housing: Individually in galvanized steel cages placed over trays.
- Diet: ad libitum, Purena Complete Rabbit Chow, Lot #197C and City of Houston
- Water: ad libitum, tap water
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 - 24.4
- Humidity (%): 40 - 60 - Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Type of application: the test substance was applied to gauze pads which had been moistened with 1 mL distilled-deionized water
- Restrainers: Yes - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 4 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Application: Two site/animal were exposed to the test substance
- Area of exposure: 1 x 1 cm
- Type of wrap if used: a polyethylene wrapper (secured with masking tape)
REMOVAL OF TEST SUBSTANCE
- Washing: No. (Test site was brushed clean)
SCORING SYSTEM: The skin was scored according to the method of Draize (see below). - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Worst case scenario based on the results reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Worst case scenario based on the results reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Worst case scenario based on the results reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Worst case scenario based on the results reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Worst case scenario based on the results reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Worst case scenario based on the results reported.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all six animals (12 test sites)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Unabraded skin (12 test sites): 7 test sites were scored with a draize score of 2 while 5 test sites had a draize score of 3, 24 hours after removal of the test patch. These changes were not observed after 48, 72, 96 hours. No edema or eschar was found at any observation time point.
Abraded skin was also scored. (These values however are not included in the final assessment of skin irritation potential of the test substance).
- abraded (12 test sites; 24 hour observation time point): Erythema score of 2 at 7 sites, and an erythema score of 3 was recorded at 5 sites. These changes were not observed after 48, 72, 96 hours. No edema or eschar was found at any observation time point. - Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance is applied to the conjunctival sac of one eye in 2 animals. The substance was tested as powder. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.69 and 2.82 kg
ENVIRONMENTAL CONDITIONS: not specified - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye treated with talcum
- Amount / concentration applied:
- Amount applied: 50 mg
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Initially, a BASF scoring system was used to score eye changes. These values were adapted to OECD Draize scores (see below).
TOOL USED TO ASSESS SCORE: not specified - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of both animals
- Time point:
- other: 24 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of both animals
- Time point:
- other: 24 and 72 hours
- Score:
- 0.167
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Bleeding seen after 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of both animals
- Time point:
- other: 24 and 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 and 72 hours
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of both animals
- Time point:
- other: 24 and 72 hours
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Slight erythema and chemosis was seen in the control eyes 1 hour and 24 hours after instillation of amorphous talcum. The effects were no longer present by the 72 hour observation time point (table 3).
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
Reference
Table 2: OECD Draize scores after treatment of the rabbit eye with Ammonium Chloride
Time |
opacity |
iritis |
erythema |
chemosis |
Comments |
1 h |
2/2 |
0/0 |
2/1 |
2/2 |
|
24 h |
2/2 |
0/0 |
3/2 |
1/2 |
|
48 h |
-/- |
-/- |
-/- |
-/- |
|
72 h |
2/2 |
0/1 |
2/2 |
1/1 |
bleeding in animal 1 |
8 d |
0/0 |
0/0 |
0/0 |
0/0 |
|
"-": data missing.
Table 3: OECD Draize scores after treatment of the rabbit eye with amorphous Talcum (Control eye)
Time |
opacity |
iritis |
erythema |
chemosis |
Comments |
1 h |
0/0 |
0/0 |
2/1 |
1/0 |
Residue in both animals |
24 h |
0/0 |
0/0 |
2/2 |
0/0 |
|
48 h |
-/- |
-/- |
-/- |
-/- |
|
72 h |
0/0 |
0/0 |
0/0 |
0/0 |
|
8 d |
0/0 |
0/0 |
0/0 |
0/0 |
|
"-": data missing.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation
In a primary dermal irritation study, performed pursuant to method of Federal Register, Vol. 43, No. 163, 1978 (Microbiological and Biochemical Assay Laboratories,1985), 6 New Zealand White were dermally exposed to 0.5 g ammonium chloride (reagent grade) applied occlusively on a gauze patch which had been moistened with water (1 mL). Application was occlusive onto the shaved or abraded skin (1 x 1 cm) for 24 hours. At the end of exposure, exposure sites were not washed. Animals were observed until total reversal of symptoms. Irritation was scored regularly using the OECD Draize method. 24 hour after removal of the test patch from non-abraded skin, 7 of the 12 exposed sites (2 sites/animal) scored for erythema, had a draize score of 2 while the remaining 5 sites had a draize score of 3. Erythema at these sites were no longer present after 48, 72 or 96 hours. No edema or eschar was found at any observation time point. On abraded test sites, the erythema scores recorded 24 hours after termination of exposure was 2 at 7 of 12 exposed sites, and an erythema score of 3 was recorded at 5 of 12 exposed sites. These changes were not observed after 48, 72, or 96 hours. No edema or eschar was found at any observation time point. The results from the abraded skin are given in conformity with Robust Study Summary requirements, however they are not included in the final assessment of the skin irritation potential of ammonium chloride.
In another dermal irritation study (BASF AG, 1968), 2 - 4 Vienna White rabbits were treated with the test substance for 1, 5, 15 minutes and 20 hours under occlusive conditions. Moistened test patches coated with neat (2 g) ammonium chloride (100%) were attached to the clipped dorsal skins of rabbit (ca. 2.5 x 2.5 cm). After the application durations of 1, 5 and 15 minutes, the application sites were washed with undiluted Lutrol and Lutrol (50%). The application sites after 20 hours exposure were not washed. The animals were observed for 8 days and skin changes were recorded on day 1, 2, 3 and 8. Very slight skin erythema was seen within 24 hours removal of test patch for animals exposed for 1, 5 and 15 minutes. Edema was not seen after treatment periods of 1, 5 and 15 mins. After 20 hours, average scores (24, 48 and 72 hours) recorded for erythema were 2.3, 2.0, 2.0 and 0.3 for animals 1, 2, 3 and 4. Scaling was still present in 1 animal and erythema was still present in another animal at the end of the observation period (day 8). Average edema scores were 2.0 ,0, and 0 for animals 1, 2, 3 and 4, respectively.
Eye Irritation
The eye irritation potential of the test substance was determined according to the protocols of a BASF test (BASF SE, 1968) comparable to OECD guideline 405. The substance was tested as powder. 50 mg ammonium chloride (p.a.) was applied to the conjunctival sac of one eye of 2 Vienna White Albino rabbits. The other eye was treated with talcum. Eyes were not washed after instillation. After instillation, the animals eyes were scored (OECD Draize method) after 10 min, 1 and 3h on the day of treatment, then after 24 and 72 hours and 8 days after instillation. Mean draize scores after 24 and 72 hours were calculated per animal for corneal opacity, iritis, conjunctivae redness and chemosis and used for assessment of irritation potential. Redness of the mucous membrane (score: 2.5 and 2.0 for animal 1 and 2, respectively), corneal opacity (score: 2.0 and 2.0 for animal 1 and 2, respectively), chemosis (score: 1.5 and 1.0 for animal 1 and 2, respectively), and mild iritis (score: 0 and 0.33 for animal 1 and 2, respectively), were observed. These effects were fully reversible within 7 days.
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008 (CLP). As a result
the test substance is considered not to be classified for skin
irritation (UN GHS No Category) under Regulation (EC) No 1272/2008, as
amended for the tenth time in Regulation (EU) No 2017/776.
In contrast, the test substance is considered to be classified for eye irritation (UN GHS Category 2) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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