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EC number: 259-210-8 | CAS number: 54546-26-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 06 June 1979 and 29 June 1979.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In-vivo study already available before implementation of the LLNA method
- Species:
- guinea pig
- Strain:
- other: albino SPF
- Sex:
- male
- Details on test animals and environmental conditions:
- A total of 15 young male albino SPF guinea pigs, weighing from 386 to 700g were obtained from the Central Institute for the Breeding of Laboratory animals TNO, Ziest, The Netherlands. The experiment was preceded by an acclimatization period of 10 days to accustom the animals to the environmental conditions prevailing in the laboratory. The guinea pigs were randomly divided into 2 groups, viz. one control group and one test group comprising 5 and 10 animals respectively. They were kept under conventional conditions and individually housed in suspended stainless steel cages, fitted with wire mesh floors and fronts. Animal room temperature, relative humidity and lighting were controlled at 23±1°C, 50±10% and 12 hours a day respectively. All guinea pigs were fed stock diet enriched with vitamin C, which was provided ad libitum with tap water.
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50%
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50%
- No. of animals per dose:
- control goup: 5
test group: 10 - Details on study design:
- Induction
Intradermal injections of the test substance were given both after mixing with Freund ’s adjuvant and also after mixing with propylene Glycol (PG). An area of 4 x 6 cm of the shoulder region was shaven with electric clippers then at short intervals, the intradermal injections were given in an area of 2 x 4 cm/ A total of 6 injections was administered in 2 rows of 3. They comprised:
1) 2 injections with 0.05 ml Freund’s Complete Adjuvant;
2) 2 injections with 0.05 ml of a 50% Herboxane dilution in propylene glycol;
3) 2 injections with 0.05 ml of a 50% Herboxane dilution in Freund’s Complete Adjuvant and propylene glycol (1:1).
A concentration of 50% herboxane was chosen for induction, because this concentration induced only moderate irritation reactions in preliminary observations.
The controls were given:
1) 2 injections with 0.05 ml Freund’s complete adjuvant;
2) 2 injections with 0.05 ml of propylene glycol;
3) 2 injections with 0.05 ml Freund’s Complete adjuvant and propylene glycol (1:1).
Topical application
One week after the injections, the same area was shaved again and topically treated with the test substance.
A patch of 2 x 4 cm Whatman 3mm filter paper was soaked in undiluted Herboxane and then placed on the shaven skin of the test animals and covered by paraplast which was kept in place by adhesive tape. This in turn was firmly secured by self-sticking bandage and left in place for 48 hours.
The controls were treated in the same way, except that the patch was not soaked in Herboxane.
Challenge
The animals were challenged at day 14 after the topical induction on the right flank of which an area of 5 x 5 cm was shaven. For this treatment, Herboxane was mixed in Vaseline. A concentration of 15% (w/w), which proved to be non-irritating in a preliminary test, was used for the challenge. A small amount of the 15% mixture was applied to a patch of 2 x 2 Whatman 3mm filter paper and then placed on the shaven area. It was covered by paraplast and kept in place by adhesive bandage and firmly secured by self-sticking tape. At the same time, the challenge treatment was applied (as described below) to 5 controls that had not been treated before.
Skin readings were made 24 hours after the challenge treatment in both control and test animals. Skin reactions were judged with the method of Draize, as described in J. Pharmacol. 82 (1944) 377-390. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The undiluted Herboxane induced neither erythema nor edema in guinea pigs upon the topical application in the induction phase of the study.
The challenge dose provoked no erythema or edema in any of the test animals and none of the controls reacted positively. From these results it is concluded that under the conditions of this experiment Herboxane induced no sensitization according to the classification of Magnusson and Kligman (1970). - Executive summary:
The experiment was conducted mainly according to the method described by Magnusson and Kligman (1970).
The undiluted Herboxane induced neither erythema nor edema in guinea pigs upon the topical application in the induction phase of the study.
The challenge dose provoked no erythema or edema in any of the test animals and none of the controls reacted positively.
From these results it is concluded that under the conditions of this experiment Herboxane induced no sensitization.
Reference
All animals remained in good health during the experiment.
The intradermal injections given during the induction phase of the study resulted in the following reactions in the test animals:
1) Freund’s Complete Adjuvant: abscesses
2) 50% Herboxane in PG: abscesses
3) 50% Herboxane in Adjuvant and PG (1:1): abscesses
The undiluted Herboxane induced neither erythema nor edema in guinea pigs upon the topical application in the induction phase of the study.
The challenge dose provoked no erythema or edema in any of the test animals and none of the controls reacted positively. From these results it is concluded that under the conditions of this experiment Herboxane induced no sensitization according to the classification of Magnusson and Kligman (1970).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
All animals remained in good health during the experiment.
The intradermal injections given during the induction phase of the study resulted in the following reactions in the test animals:
1) Freund’s Complete Adjuvant: abscesses
2) 50% Herboxane in PG: abscesses
3) 50% Herboxane in Adjuvant and PG (1:1): abscesses
The undiluted Herboxane induced neither erythema nor edema in guinea pigs upon the topical application in the induction phase of the study.
The challenge dose provoked no erythema or edema in any of the test animals and none of the controls reacted positively. From these results it is concluded that under the conditions of this experiment Herboxane induced no sensitization according to the classification of Magnusson and Kligman (1970).
Migrated from Short description of key information:
The undiluted Herboxane induced neither erythema nor edema in guinea pigs upon the topical application in the induction phase of the study.
The challenge dose provoked no erythema or edema in any of the test animals and none of the controls reacted positively.
From these results it is concluded that under the conditions of this experiment Herboxane induced no sensitization.
Justification for selection of skin sensitisation endpoint:
The study was conducted on the target substance in vivo in an appropriate test species according to internationally recognised guidelines.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
A skin sensitiser is defined as a substance that will lead to an allergic response following skin contact.
Sensitisation includes two phases,
The induction of specialised immunological memory in an individual by exposure to an allergen.
Elicitation where the production of cell-mediated or antibody mediated allergic response by exposure of a sensitised individual to an allergen.
For skin sensitisation, an induction phase is required in which the immune system learns to react; clinical symptoms can then arise when subsequent exposure is sufficient to elicit a visible skin reaction (elicitation phase). Lower levels are usually required for elicitation than are required for induction.
Substances shall be classified as a category 1 skin sensitiser if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons, or if there are positive results form an appropriate animal test.
When an adjuvant type guinea pig test method for skin sensitisation is used, a response of at least 30 % of the animals is considered positive.
The undiluted test substance induced neither erythema nor edema in guinea pigs upon the topical application in the induction phase of the study.
The challenge dose provoked no erythema or edema in any of the test animals.
It can therefore be concluded that the test substance is not classified as a skin sensitiser.
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