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EC number: 224-644-9 | CAS number: 4435-53-4
- 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1973
- Justification for type of information:
- Human Repeat Insult Patch Study to demonstrate no potential for skin sensitisation.
Data source
Materials and methods
Method
- Type of population:
- general
- Subjects:
- 200 Human Subjects: 80 Males, 120 Females
- Route of administration:
- dermal
- Details on study design:
- group of 200 individuals who qualified were selected from a local population. The criteria for selecting these individuals were:
1. General well-being.
2. Absence of any skin diseases which might be confused with skin reactions
from the test material.
3. Willingness to cooperate.
4. Dependability and intelligence in following directions.
5. Reading, understanding, and signing an informed-consent contract.
(In the case of minors, parental consent was obtained.)
Sites on the upper arm of each individual were designated for contact with the test material. A total of sixteen applications, each of twenty-four hours'
duration, were scheduled to be carried out .
Results and discussion
- Results of examinations:
- The observations of each individual on a daily basis are appended.
1. Skin Changes Accompanying Application No.1:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
2. Skin Changes Accompanying Application Nos. 2 through 15:
Visible skin changes signifying reaction to injury were observed in 2 of the 200 subjects (Subject No. 31, Age 15, and Subject No. 34, Age 43).
3. Skin Changes Accompanying Challenge Application:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
Applicant's summary and conclusion
- Conclusions:
- Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test
subjects. In this case, since 200 subjeets were used, we may predict with 95% certainty that at least 98.17% of a general population will not
be sensitized by this material. - Executive summary:
Under completely occluded conditions, Celanese Chemical Company - 50-50 Blend in Wat.er of 1, 3 Butylene Glycol, was capable of eliciting
visible skin changes consistent with the criteria deemed characteristic of a mild fatiguing agent in 2 out of 200 subjects.
In the opinion of the investigator, Celanese Chemical Company - 50-50 Blend in Water of 1, 3 Butylene Glycol may be considered safe to use in contact with the skin insofar as primary irritation or sensitization are concerned if the conditions of contact do not exceed those of the test procedure.
Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test
subjects. In this case, since 200 subjeets were used, we may predict with 95% certainty that at least 98.17% of a general population will not
be sensitized by this material.
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