Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 285-332-6 | CAS number: 85068-73-1
- 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 study. Buehler test method similar to described in OECD 406, GLP study. The test substance did not cause dermal sensitization in guinea pigs under the conditions of this study.
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:
- October 1991 - December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Not specified in the test report.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BuckberG Lab Animals, Tomkins Cove, New York.
- Females (if applicable) nulliparous and non-pregnant: Not specified.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: test group: males: 365.5 (SD=21.97) g; females: 345.1 (SD=15.52) g
- Housing: Guinea pigs were housed individually in 1/2" stainless steel wire mesh cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council. Waste material was removed daily. Cages and feeders sanitized every two weeks.
- Diet (e.g. ad libitum): ad libitum. Purina Guinea Pig DietR. Food was checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): ad libitum (fresh tap water). Water was monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.
- Acclimation period: Minimum of 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3ºC,
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12-h dark/light cycle - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.3 mL
- Day(s)/duration:
- 3 applications (once per week for 3 weeks) of 6 hours exposure each.
- Adequacy of induction:
- other: According to a dose range finding study, the test chemical was dosed as received.
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.3 mL
- Day(s)/duration:
- 1 application of 6 hours
- Adequacy of challenge:
- other: According to a dose range finding study, the test chemical was dosed as received.
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
4 previously unexposed animals were each exposed to 1.0, 10 and 50% of the test article in acetone and as received. The treated sites (left dorsal surface of each animal) were examined after dosing and scored at 24 hours for erythema according to a similar grading scale shown in paragraph 23 of OECD TG 406. No signs of erythema were observed at any treatment site with the exception of slightly patchy erythema in one animal. Therefore, the test article was dosed as received.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 x 6 hours
- Test groups: 1
- Control group: 1 negative and 1 positive control groups.
- Site: left dorsal surface
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 0.3 mL/site
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1 negative and 1 positive control groups.
- Site: test and positive groups: left dorsal surface; negative group: 80% ethanol on the left flank and test article on the right flank.
- Concentrations: 0.3 mL/site
- Evaluation (hr after challenge): 24 and 48 hours
- Challenge controls:
- The negative control animals (10 animals) were challenged with 80% ethanol on the left flank and test article on the right flank.
- Positive control substance(s):
- yes
- Remarks:
- A concurrent positive control group consisting of 5 animals was treated with (0.3%) 1-chloro-2,4-dinitrobenzene (DNCB) in ethanol (80%).
- Positive control results:
- No to severe erythema with/without edema was observed in the positive control animals during the induction. A positive response was elicited in the animals challenged with the positive control article. More details are shown in the table below.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 mL
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.3 mL (test chemical on right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.3 mL (test chemical on right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test substance did not cause dermal sensitization in guinea pigs under the conditions of this study.
- Executive summary:
The test substance was tested for delayed contact hypersensitivity in the Buehler Assay (GLP study). In a preliminary dose-range-finding study two male and two female Hartley guinea pigs were exposed to 1.0, 10 and 50% of the test material in acetone and as received. Based upon the results of this study, the test article was dosed as received. For the induction first stage, three groups of Hartley guinea pigs received the test article (10 males and 10 females), the positive control 0.3% 1-chloro-2,4-dinitrobenzene (2 males and 3 females) and the negative control 80% ethanol (5 males and 5 females), respectively, by topical application once per week for a total of three six-hour insult periods. Treated sites were examined and scored at 24 and 48 hours for erythema according to grading scale of 0 to 3 similar to that set out in paragraph 23, OECD TG 406. No signs of erythema were observed in the test article-treated or negative control animals. No to severe erythema with/without edema was observed in the positive control animals. 14 days after the last induction exposure, all animals were challenged (6 hours exposure at the same dose) at a previously untested site. A positive response was elicited in the animals treated with the positive control. No responses were observed in any test article-treated animal. No responses were observed in any control animal challenged with 80% Ethanol on the left flank and test article on the right flank. All animals gained weight and survived to study termination. Based upon these observations, it was concluded that the test substance did not cause dermal sensitization in guinea pigs under the conditions of this study.
Reference
Table 2: Individual animal scores
Induction | Challenge | |||||||||||
week | 1 | 2 | 3 | 5 | ||||||||
Reading (hrs.) | 24 | 48 | 24 | 48 | 24 | 48 | 24 | 48 | ||||
Animal no. | Sex | |||||||||||
Et-NENA | 3836 |
M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3837 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3838 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3839 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3840 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3841 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3842 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3843 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3844 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3845 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3846 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3847 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3848 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3849 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3850 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3851 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3852 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3853 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3854 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
3855 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Positive control (0.3% DNCB) |
3866 | M | 0 | 0 | + | + | 1 | 2 | 3 | 2 | ||
3867 | M | 0 | 0 | + | + | 1 | 3 | 3 | 3 | |||
3868 | F | 0 | 0 | + | + | 1 | 1 | 3 | 2 | |||
3869 | F | 0 | 0 | 1 | 1 | + | + | 3 | 3 | |||
3870 | F | 1 | 1 | 1 | 1 | 3 | 3 | 3 | 3 | |||
L | R | L | R | |||||||||
Negative control (80% ethanol) |
3856 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3857 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3858 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3859 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3860 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3861 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3862 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3863 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3864 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3865 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
L - Left flank (80% ethanol)
R = Right flank (EtNENA)
Table 3: Incidence and Severity of Responses at Challenge
Study Number | Challenge (Naive site) | |||
24 hours | 48 hours | |||
Incidence | Severity | Incidence | Severity | |
Et-NENA | 0/20 | 0.0 | 0/20 | 0.0 |
Negative control-Et-NENA |
0/10 | 0.0 | 0/10 | 0.0 |
80% ethanol |
0/10 | 0.0 | 0/10 | 0.0 |
Positive control |
5/5 | 3.0 | 5/5 | 2.6 |
Table 4. Summary of Body Weights (g)
Test group | |||
Animal Number | Sex | Initial | Final |
3836 | M | 394 | 691 |
3837 |
M | 350 | 563 |
3838 |
M | 366 | 597 |
3839 |
M | 396 | 708 |
3840 |
M | 378 | 693 |
3841 | M | 334 | 532 |
3842 | M | 343 | 548 |
3843 | M | 385 | 638 |
3844 | M | 361 | 561 |
3845 | M | 348 | 568 |
x | 365.5 | 609.9 | |
S.D. | 21.97 | 66.92 | |
N | 10 | 10 | |
3846 | F | 354 | 543 |
3847 | F | 323 | 478 |
3848 | F | 345 | 500 |
3849 | F | 367 | 473 |
3850 | F | 326 | 594 |
3851 | F | 353 | 551 |
3852 | F | 362 | 513 |
3853 | F | 339 | 525 |
3854 | F | 328 | 470 |
3855 | F | 354 | 566 |
x | 345.1 | 521.3 | |
S.D. | 15.52 | 42.18 | |
N | 10 | 10 |
Negative control | |||
Animal Number | Sex | Initial | Final |
3856 | M | 376 | 637 |
3857 | M | 411 | 699 |
3858 | M | 371 | 607 |
3859 | M | 328 | 533 |
3860 | M | 383 | 624 |
x | 373.8 | 620.0 | |
S.D. | 29.91 | 59.76 | |
N | 5 | 5 | |
3861 | F | 382 | 553 |
3862 | F | 318 | 513 |
3863 | F | 352 | 511 |
3864 | F | 363 | 545 |
3865 | F | 345 | 556 |
x | 352.0 | 535.6 | |
S.D. | 23.59 | 21.93 | |
N | 5 | 5 |
Positive control | |||
Animal Number | Sex | Initial | Final |
3866 | M | 349 | 593 |
3867 | M | 346 | 536 |
x | 347.5 | 564.5 | |
S.D. | 2.12 | 40.31 | |
N | 2 | 2 | |
3868 | F | 312 | 374 |
3869 | F | 347 | 556 |
3870 | F | 357 | 541 |
x | 338.7 | 490.3 | |
S.D. | 23.63 | 101.03 | |
N | 3 | 3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the substance does not need to be classified for skin sensitisation according to CLP Regulation no. 1272/2008.
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.