Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 two in vivo skin sensitisation studies in guinea pigs comparable to OECD guideline 406 (Hoechst, 1986), no skin sensitising properties of the test item were determined.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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 - Route:
- other: intradermal and epicutaneous (occlusive)
- Vehicle:
- physiological saline
- Remarks:
- (0.9%)
- Concentration / amount:
- - 1st Induction: 5%
- Epicutaneous Induction 25 % - 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
- 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
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 540/9-82-025
- 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.
- Species:
- guinea pig
- Strain:
- other: Pribright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: About 8 weeks
- Weight at study initiation: Mean 240 g - Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9 % NaCl Solution
- Concentration / amount:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9 % NaCl Solution
- Concentration / amount:
- 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. 0.5 mL 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 0.5 mL 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 - Positive control substance(s):
- not specified
- Reading:
- other: induction
- Group:
- test chemical
- 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
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
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.
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).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a dermal sensitization study with ammonium chloride (99.1% pure), 8 weeks old guinea pigs [Pirbright-White (Hoe: DHPK (SPFLac))] were tested according to EPA 540/9-82-025 (November 1982, revised at November 1984), a method comparable to OECD TG 406 (Hoechst, 1986). The control group contained 20 animals and the test group contained 10 animals. A satellite group containing 5 animals was also included. Intradermal inductions were performed with 5% ammonium chloride in 0.9 % NaCl mixed with Freund's complete adjuvant (FCA). 8 days later, topical inductions were carried out under occlusive conditions for 48 hours with 25 % ammonium chloride in 0.9 % NaCl. Following a 13 day break, challenge exposures were performed epicutaneously (occlusive, 24 hours) with 10 % ammonium chloride in 0.9 % NaCl. 24 and 48 hours post termination of exposure, two of ten animals (10 %) in the treatment group had a positive reaction. A very slight barely noticeable erythema was seen at the application sites of these animals. The remaining animals showed no irritation effects. No sign of skin irritation was seen in control animals. A positive control testing was not included In a supporting skin sensitisation test with guinea pigs (maximisation test), ammonium chloride also appeared to be non skin sensitising (Bayer Crop, 1987). The treated animals did not show signs of toxicity throughout the study period. During induction very slight to slight edema were observed in the treatment group. During 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 the treatment group demonstrated a positive reaction after the challenge exposure (the criteria: the limit value of 30 percent).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitization
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is considered not to be classified for skin sensitisation (UN GHS No Category) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.