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EC number: 407-410-2 | CAS number: -
- 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:
- 1991-01-29 to 1991-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to outdated OECD Guideline 406.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed prior to availability of LLNA methodology.
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen/Kreis Paderborn
- Age at study initiation: 5-7 weeks
- Weight at study initiation: mean of 356 g (315-393 g)
- Housing: 5 animals per cage (Makrolon-cages type IV)
- Diet (e.g. ad libitum): Altromin 3020 pellets ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): ca. 50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 % (w/v)
Topical induction: 25 % (w/v)
Challenge: 25 % (w/v)
[25% is the maximum concentration that can be formulated] - Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 % (w/v)
Topical induction: 25 % (w/v)
Challenge: 25 % (w/v)
[25% is the maximum concentration that can be formulated] - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
- Concentrations: 3, 6, 12 and 25 % (w/v)
- Test animals: 4
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: Intradermal -, topical induction 48 h
- Test groups: 1
- Control group: 1
- Site: dorso-cranial, -medial and -caudal
- Frequency of applications: Intradermal once initially, topical induction once after 7 d
- Duration: 7 d
- Concentrations: 5 % (w/v) for interdermal and 25 % (w/v) for topical
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 d after topical intradermal induction
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: Left flank for test substance application and right flank for negative control
- Concentrations: 25 % (w/v)
- Evaluation (hr after challenge): 48 and 72 h - Challenge controls:
- 10 negative control animals
- Positive control substance(s):
- no
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: test group. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: test group. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: negative control. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After challenge with a 25 % formulation of the test item no skin reactions occurred, neither in the test nor in the control group. The test substance is considered not sensitising to the skin.
- Executive summary:
In a GLP-compliant dermal sensitisation study according to OECD guideline 406 with TCD-emulsifier (25 % w/v in polyethylene glycol E400), 20 male young adult guinea pigs (strain: Bor:DHPW) were tested using the method of Magnusson and Kligman (GPMT). No mortalities or clinical symptoms were observed. A 25 % solution of the test item (the maximum attainable concentration for formulations) did not cause primary irritation. Therefore, animals were treated with sodium lauryl sulfate (SLS) prior to topical application of the test item to induce skin irritation.
The animals of the test group were exposed intradermally (5 % w/v) to the test substance, followed by a single topical exposure (25 % w/v) after 7 days. The topical challenge (25 % w/v) was conducted 21 days after the initial intradermal induction for 24 h. Observations were made after 48 and 72 h. None of the exposed animals showed signs of an allergic reaction.
In this study, the test item is not a dermal sensitiser according to Regulation (EC) 1272/2008.
Reference
No symptoms and no mortalities occurred during the treatment. The gain in weight of the test group was equal to the control group. No skin reactions occurred during the experiment.
The clinical findings for the pilot study for the topical induction having applied test formulations of 3, 6, 12 to a maximum of 25 % are given below. The pilot studies of the same design for finding the application concentration for the challenge yielded exactly the same results for animals 41 to 45.
Erythema and edema:
Animal |
3 % |
6 % |
12 % |
25 % |
||||
48 h |
72 h |
48 h |
72 h |
48 h |
72 h |
48 h |
72 h |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
The clinical findings for the challenge after 48 and 72 h having applied a 25 % (w/v) test formulation are given below.
Erythema and edema:
Animal |
Control group |
|||
Test substance patch |
Control patch |
|||
48 h |
72 h |
48 h |
72 h |
|
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
9 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
Test substance group |
||||
21 |
0 |
0 |
0 |
0 |
22 |
0 |
0 |
0 |
0 |
23 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
25 |
0 |
0 |
0 |
0 |
26 |
0 |
0 |
0 |
0 |
27 |
0 |
0 |
0 |
0 |
28 |
0 |
0 |
0 |
0 |
29 |
0 |
0 |
0 |
0 |
30 |
0 |
0 |
0 |
0 |
31 |
0 |
0 |
0 |
0 |
32 |
0 |
0 |
0 |
0 |
33 |
0 |
0 |
0 |
0 |
34 |
0 |
0 |
0 |
0 |
35 |
0 |
0 |
0 |
0 |
36 |
0 |
0 |
0 |
0 |
37 |
0 |
0 |
0 |
0 |
38 |
0 |
0 |
0 |
0 |
39 |
0 |
0 |
0 |
0 |
40 |
0 |
0 |
0 |
0 |
Bodyweights of animals of the control and test substance group on day 0 and 24 are given below.
Control group |
Test substance group |
||||
Animal |
bw [g] on day 0 |
bw [g] on Day 24 |
Animal |
bw [g] on day 0 |
bw [g] on Day 24 |
1 |
315 |
481 |
21 |
318 |
467 |
2 |
339 |
482 |
22 |
338 |
580 |
3 |
334 |
523 |
23 |
391 |
495 |
4 |
332 |
489 |
24 |
365 |
535 |
5 |
359 |
501 |
25 |
390 |
489 |
6 |
335 |
461 |
26 |
338 |
488 |
7 |
347 |
491 |
27 |
375 |
545 |
8 |
343 |
483 |
28 |
353 |
497 |
9 |
363 |
518 |
29 |
385 |
533 |
10 |
368 |
535 |
30 |
364 |
556 |
11 |
357 |
529 |
31 |
337 |
465 |
12 |
333 |
483 |
32 |
372 |
514 |
13 |
367 |
503 |
33 |
352 |
485 |
14 |
365 |
516 |
34 |
357 |
471 |
15 |
369 |
517 |
35 |
372 |
534 |
16 |
316 |
498 |
36 |
360 |
550 |
17 |
367 |
533 |
37 |
345 |
490 |
18 |
357 |
547 |
38 |
388 |
579 |
19 |
378 |
565 |
39 |
367 |
539 |
20 |
354 |
529 |
40 |
393 |
549 |
Mean |
350 |
509 |
Mean |
363 |
518 |
S |
18 |
26 |
S |
21 |
36 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a GLP compliant dermal sensitization study according to OECD guideline 406 with TCD-emulsifier (25 % w/v) in polyethylene glycol E400, 20 male young adult guinea pigs (strain: Bor:DHPW) were tested using the method of Magnusson and Kligman (GPMT). No mortalities or clinical symptoms were observed. A 25 % solution of the test item (the maximum attainable concentration in formulations) did not cause primary irritation. Therefore, animals were treated with sodium lauryl sulfate (SLS) prior to topical application of the test item to induce skin irritation.
The animals of the test group were exposed intradermally (5 % w/v) to the test substance, followed by a single topical exposure (25 % w/v) after 7 days. The topical challenge (25 % w/v) was conducted 21 days after the initial intradermal induction for 24 h. Observations were made after 48 and 72 h. None of the exposed animals showed signs of an allergic reaction.
Migrated from Short description of key information:
Negative guinea pig maximization test (Magnusson and Kligman) under GLP.
Justification for selection of skin sensitisation endpoint:
GLP guideline study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a reliable GLP OECD 406 study, the test substance did not show any sensitizing potential. Classification is not warranted.
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