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EC number: 236-751-8 | CAS number: 13473-90-0
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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:
- 3 January 1986 - 8 February 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD guideline 406 and under GLP conditions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 7-11 weeks
- Weight at study initiation: 334-411 g
- Housing: In groups of up to 4 animals
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum, tap water
- Acclimation period: Min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 45-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-12 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- Intradermal induction: 0.1% w/w
Topical induction: 50% w/w
Topical challenge: 50% w/w - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- Intradermal induction: 0.1% w/w
Topical induction: 50% w/w
Topical challenge: 50% w/w - No. of animals per dose:
- Treatment group: 20
Control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Dose levels for each of the three stages of the main study were determined. Groups of two or more guinea pigs were used and up to two dose levels were tested on each group of animals.
Intradermal injection: Dilutions of test material in distilled water were tested to determine the highest level, up to 5% (w/v), that could be well tolerated both locally and systemically.
Topical application: Dilutions of the test material in distilled water were tested to determine the highest level which did not produce excessive inflammation and irritation in animals injected with FCA at least seven days previously.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 48 hours (epicutaneous)
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: Shoulder region (40x60 mm)
- Frequency of applications: Once
- Concentrations:
Treatment group:
- Intradermal (row of 3x0.1 ml injections on each side of the midline):
1. FCA plus distilled water in the ratio 1:1
2. A 0.1% (w/v) dilution of test material in distilled water
3. A 0.1% (w/v) dilution of test material in a 1:1 prepartion of FCA plus distilled water
- Epicutaneous:
Topical occlusive application of 0.2-0.3 ml test material (50% w/w in distilled water) on filter paper
Control group:
- Intradermal (row of 3x0.1 ml injections on each side of the midline):
1. FCA plus distilled water in the ratio 1:1
2. Distilled water
3. FCA plus distilled water in the ratio 1:1
- Epicutaneous:
Topical occlusive application of 0.2-0.3 ml distilled water on filter paper
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period: 24 hours
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: 50-70 x 50 mm area on both flanks
- Concentrations: 50% in distilled water
- Evaluation (hr after challenge): 24 and 48 hours after removal of dressing. Four-point scale was used to record erythematous reactions:
0 - no reaction
1 - scattered mild redness
2 - moderate and diffuse redness
3 - intense redness and swelling
Number of positive responses was recorded, the sensitization response was calculated (% positive reactions) and this was compared with the following scale:
0% - non-sensitizer
1-28% - mild sensitizer
29-65% - moderate sensitizer
66-100% - strong sensitizer
OTHER:
Body weights measured at start and end of study. - Challenge controls:
- Vehicle only patches on treated and control group animals
- Positive control substance(s):
- no
- Positive control results:
- No information on concurrent positive controls
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% Chlorhydrol Ultrafine
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse skin reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% Chlorhydrol Ultrafine
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse skin reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% Chlorhydrol Ultrafine
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse skin reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse skin reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% Chlorhydrol Ultrafine
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse skin reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% Chlorhydrol Ultrafine. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse skin reactions.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No evidence of skin sensitisation was seen in this study performed with the read-across substance aluminium chlorohydrate.
- Executive summary:
The present sudy was used to determine the sensitizing potential of Chlorhydrol Ultrafine in guinea pigs (Guinea Pig Maximisation Test, OECD 406). 20 animals were exposed once intradermally (0.1%) and 2 times epicutaneously (50%) to the test article. 10 control animals were only exposed once epicutaneously (50%) during challenge. Positive skin reactions were evaluated according to a grading scale, and were used to calculate the sensitization rate. Body weights were measured before and after the study.
No positive skin were observed, the sensitization rate was established to be 0%. Body weight gain was comparable between the test and control group.
As the sensitization rate of 0% does not exceed the threshold value of 30%, the substance does not need to be classified as a sensitizer based on the classification criteria outlined in Annex I of CLP (1272/2008).
Reference
Bodyweight gains of guinea pigs in the test group between day 0 and day 24 were comparable to those in the control group over the same period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No evidence of skin sensitisation was seen in this study performed with the read-across substance aluminium chlorohydrate.
Migrated from Short description of key information:
A Maximisation study is available with the read-across substance, aluminium chlorohydrate
Justification for selection of skin sensitisation endpoint:
Only available study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No evidence of skin sensitisation was seen in a maximisation study performed with chlorhydrol ultrafine (aluminium chlorohydrate)
Justification for classification or non-classification
The available data do not indicate any skin sensitisation potential for the read-across substanc aluminium chlorohydrate. No classifcation is proposed according to the CLP Regulation or the Dangerous Substances Directive.
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