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EC number: 271-638-7 | CAS number: 68603-11-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, conducted to a valid guideline and was performed under GLP conditions. The study has been assigned a reliability score of 2 since it was conducted on a structural analogue. Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (the environmental conditions deviated from the guideline as the ranges used were larger)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, PA
- Animal husbandry was based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Age at study initiation: 6 weeks (males); 8 weeks (females)
- Weight at study initiation: 366-439 g (males); 319-380 g (females)
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Guinea Pig Chow #5026 (Purina Mills, Inc.), ad libitum
- Water (e.g. ad libitum): municipal tap water treated by reverse osmosis, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-77 ºF (16-25 ºC)
- Humidity (%): 23-49 %
- Air changes (per hr): 10-15 air charges per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 05/12/2000 To: 11/01/2001 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction exposure: 50% or 40 % w/v in the vehicle
1st Challenge and challenge control: 25% w/v in the vehicle
2nd Challenge: 20 and 10% w/v in the vehicle - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction exposure: 50% or 40 % w/v in the vehicle
1st Challenge and challenge control: 25% w/v in the vehicle
2nd Challenge: 20 and 10% w/v in the vehicle - No. of animals per dose:
- - Twenty animals were used in the test group, 10 males and 10 females
- Ten animals were used for the positive control, 5 males and 5 females
- Ten animals were used for the challenge control group, 5 males and 5 females - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three, on days 1, 7 and 14
- Exposure period: 6 hours, after which the site was wiped down with gauze moistened in deionised water to remove any residue
- Site: left dorsal side of the animal, called site 1
- Test groups: 50% in the first induction then 40% for the second and third induction exposures, which were all applied at site 1
- Control group: animals were exposed three times to 0.1% concentration of the test material in the same manner as the test group
- Frequency of applications: every seven days until all three consecutive applications have been administered
B. CHALLENGE EXPOSURE
- Rest time before challenge: approximately 2 weeks
- No. of exposures: two, the Challenge and the Rechallenge
- Exposure period: 6 hours, after which the site was wiped down with gauze moistened in deionised water to remove any residue
- Day(s) of challenge: application on Day 28 and Day 35 for the challenge and rechallenge respectively
- Site: three sites were used, for exposure, on the right dorsal side of the animal, called site 2, 4 and 6
- Test groups: 25% w/v of the test material was applied to site 2 in the challenge, then 20% and 10% w/v was applied at sites 4 and 6 during the rechallenge
- Challenge control group: the challenge control was performed concurrently with the test and applied in the same manner as the test material
- Positive Control group: the DNCB control and DNCB challenge were performed on Day 28 only, at site 2 and 4. 0.1% was applied at site 2 and 0.05% was applied at site 4
- Wrapping: following application of the test material, challenge control or positive control the trunk of the animal was wrapped in an occlusive manner
C. OBSERVATIONS
-Dermal reactions were recorded at 24 and 48 hours following application of the test material during induction exposure and both the challenge and rechallenge
-Clinical observations and mortality were recorded twice daily
-Body weights were recorded on the day before dosing in the induction, challenge and rechallenge
- All animals were euthanized after the final scoring - Positive control substance(s):
- yes
- Remarks:
- DNCB (1-chloro-2,4-dinitrobenzene) in acetone/ethanol: 0.1% w/v for the induction exposure and then 0.1% and 0.05% w/v in the challenge exposure
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % w/v
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % w/v. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % w/v
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % w/v. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- other: challenge control
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % w/v
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge control. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % w/v. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- other: challenge control
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % w/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge control. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % w/v. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% w/v
- 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: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 205 w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 205 w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: rechallenge control
- Dose level:
- 20 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: rechallenge control. Dose level: 20 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: rechallenge control
- Dose level:
- 20% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: rechallenge control. Dose level: 20% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: rechallenge control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: rechallenge control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: rechallenge control
- Dose level:
- 10% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: rechallenge control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test there is no significant difference in the dermal response after the challenge or rechallenge applications of the test material. The test material was determined to be not sensitising and therefore does not require classification according to Regulation (EC) 1272/2008.
- Executive summary:
In a GLP compliant Buehler test, the skin sensitisation potential was assessed according to standardised guidelines OECD 406 and EPA OPPTS 870.2600.
Twenty Guinea pigs were exposed to the test material first using three induction exposures at 50 and 40 % w/v, then in a challenge and rechallenge exposure at 25, 20 and 10 % w/v. None of the test animals displayed a dermal reaction greater than the challenge control during the challenge or rechallenge. Under the conditions of the test, the test material was determined to be not sensitising and therefore does not require classification according to Regulation (EC) 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a Buehler test, the skin sensitisation potential was assessed according to standardised guidelines OECD 406 and EPA OPPTS 870.2600.
Twenty Guinea pigs were exposed to the test material first using three induction exposures at 50 and 40 % w/v, then in a challenge and rechallenge exposure at 25, 20 and 10 % w/v. None of the test animals displayed a dermal reaction greater than the challenge control during the challenge or rechallenge. Under the conditions of the test, the test material was determined to be not sensitising and therefore does not require classification in accordance with EU criteria.
The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. However, the study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.
Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.
The available data are considered to be complete and the conclusion, not sensitising, was taken forward for risk assessment.
Migrated from Short description of key information:
Not sensitising, male/female Guinea pig, OECD 406, EPA OPPTS 870.2600, Rodabaugh 2001
Justification for selection of skin sensitisation endpoint:
Only one study is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material did not elicit a response in the Buehler test and therefore does not meet the criteria for classification as a skin sensitiser.
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