Registration Dossier
Registration Dossier
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: 254-400-7 | CAS number: 39290-78-3
- 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

Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 January 1986 - 8 February 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD guideline 406 and under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- criteria for classification of sensitizing potential is used (see materials&methods). No data on control positive.
- Principles of method if other than guideline:
- At the time of study completion (1986), the LLNA OECD test method was not adopted.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of study completion (1986), the LLNA OECD test method was not adopted.
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Chlorhydrol ultrafine
- Physical state: Solid (white powder)
- Storage condition of test material: At room temperature
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- distilled water
- Concentration / amount:
- 0.1% w/w
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled water
- Concentration / amount:
- 50% w/w
- Day(s)/duration:
- Day 8 / 48 hours
- Adequacy of induction:
- other: highest level which did not produce excessive inflammation
- 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:
- No data.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- Key result
- 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:
- no indication of skin sensitisation
- 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 advese skin reactions
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Bodyweight gains of guinea pigs in the test group betwee day 0 and day 24 were comparable to those in the control group over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this Guinea Pig Maximisation Test (OECD 406), Chlorhydrol Ultrafine did not induce any adverse skin reactions in the test group (sensitization rate: 0%). Therefore, the substance is not classified as a sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, 20 female Dunkin-Hartley guinea pigs were exposed once intradermally (0.1%) and 2 times epicutaneously (50%) to the test article. Ten 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 study.
No mortality was observed during the test. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. Chlorhydrol Ultrafine produced a 0 % (0/20) sensitisation rate and was considered to be a non-sensitiser to guinea pig skin. Body weight gain was comparable between the test and control group.
Under the conditions of this Guinea Pig Maximisation Test (OECD 406), Chlorhydrol Ultrafine did not induce any adverse skin reactions in the test group (sensitization rate: 0%). Therefore, the substance is not classified as a sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
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.

Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
This website uses cookies to ensure you get the best experience on our websites.
Find out more on how we use cookies.