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EC number: 281-650-4 | CAS number: 84000-94-2
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From July 16, 1979 to September 6, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted on a similar substance, the complete justification for the Read Across approach is reported at section 13. The original Reliability of the test is 2
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test conducted in 1979. No LLNA is required if older data is available.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:bred at Bantin and Kingman Ltd
- Age at study initiation: ~10 weeks old
- Weight at study initiation: 375 to 485 g
- Housing: housed individually in Macrolon cages, type 3, assigned to the different groups by means of random numbers.
- Diet : The animals received ad libitum standard guinea pig pellets - NAFAG, N°. 830 supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 55± 5%
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day - Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- complete Bacto Adjuvant
- Concentration / amount:
- first induction exposure: 0.1 ml of 0.1 % of test substance
secndary induction exposure: mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)
challenge exposure: 0.1 % suspension of test substance in physiological saline
Rechallenge exposure: 3 % of test item in Vaseline - Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- complete Bacto Adjuvant
- Concentration / amount:
- first induction exposure: 0.1 ml of 0.1 % of test substance
secndary induction exposure: mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)
challenge exposure: 0.1 % suspension of test substance in physiological saline
Rechallenge exposure: 3 % of test item in Vaseline - No. of animals per dose:
- 10 per sex per dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE INTRADERMAL
- No. of exposures: the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of test item in physiological saline.
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs, one control group was treated with the vehicle alone
- Site: shaven skin of the right flank and the back
- Frequency of applications: daily
- Duration: 10 intracutaneous injections
- Concentrations: 0.1 % suspension of test substance
MAIN STUDY
A2. INDUCTION EXPOSURE INTRADERMAL
- No. of exposures: During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)
- Exposure period: During the second and third week of the induction period
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: shaven skin of the right flank and the back
- Duration: Fourteen days
B. CHALLENGE EXPOSURE
- No. of exposures: challenge injection of 0.1 ml
- Day(s) of challenge: Fourteen days after the last sensitizing injection
- Exposure period: Fourteen days after the last sensitizing injection (induction period)
- Test groups: 10 males and 10 females guinea pigs
- Control group: 10 males and 10 females guinea pigs
- Site: skin of the left flank
- Concentrations: 0.1 % suspension of test substance in physiological saline
- Evaluation (hr after challenge): Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
C. SUBIRRITANT DOSE (RECHALLENGE):
It was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The 3% of test item in Vaseline.
OTHER:
Bodyweights were recorded immediately before starting the experiment (control values) and at termination of the study. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml of 0.1 % suspension of test item in physiological saline
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml of 0.1 % suspension of test item in physiological saline . No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% of test item in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 30% of test item in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- other: Not classified according to the CLP Regulation
- Conclusions:
- The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.
- Executive summary:
Under the experimental conditions employed, significant differences between the test group and the vehicle treated controls were only seen after intradermal challenge application of test substance, i.e. when the skin barrier was intentionally by-passed. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.
Reference
No difference between the test and the control group was seen after epidermal challenge application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No tests are available on the substance in itself, nevertheless the skin sensitisation potential of the target substance was assessed by means of the Read Across approach. The complete Justification for the Read Across is detailed at section 13.
Two tests were proposed in order to complete the assessment:
The selected key study [Huntsman Textile Effects GmbH, 1979] was conducted according to the AFDO Method on the Similar Substance 01. Under the test condition no animal showed positive reaction, therefore under the test condition the substance is considered as non sensitizer for skin.
Even the second study was conducted on the Similar Substance 01, reported as supporting study [Huntsman Textile Effects GmbH, 1979], and showed no positive reaction on the tested animals.
The key study was chosen due to the purity of the test item higher than the one of the supporting study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) 3.4.1.2 Skin sensitiser means a substance that will lead to an allergic response following skin contact. The experiment conducted in read across clearly shows that the substance is not capable to produce positive reactions after treatment with the test substance and no toxic symptoms were recorded.
Basred on the experimental results the test article is considered a non sensitizer and no classification is warranted.
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