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EC number: 412-720-6 | CAS number: 156653-67-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 April 1993 to 14 May 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU & OECD test guidance in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- See below
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Test species: Pirbright-White guinea pig
Sex: female
Strain: Hoe: DHPK (SPFLac)
Origin: HOECHST AG, Kastengrund, SPF breeding colony
Body weight at start of study: x = 305 g (= 100.0%)
x min = 273 g (-10.5%)
x max - 346 g (+13.4%)
n -15
Randomisation schemes: 614/92
Animal maintenance: in fully air-conditioned rooms in Hakrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
Ambient temperature: 22 ±3 °C
Rel . atmospheric humidity: 55 ± 20 %
Lighting time: 12 hours daily
Acclimatisation: at least 5 days
Diet: Altromin 3112 for guinea pigs and rabbits, ad 1ibitum
Water: tap water in plastic bottles, ad libitum
Animal identification: fur-marking with KMnO4 and cage numbering
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 % in isotonic saline
5 % in isotonic saline
1 % in isotonic saline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 % in isotonic saline
5 % in isotonic saline
1 % in isotonic saline
- No. of animals per dose:
- Determination of the primary non-irritant concentration: 6
Determination of the tolerance of intradermal injections: 3
Escort group: 5
Control group: 5
Treatment group: 10 - Details on study design:
- The following vehicles were used:
Freund's Complete Adjuvant (Behringwerke AG, Marburg)
isotonic saline (sterile, pyrogen-free; Fresenius AG, Bad Homburg)
Freund's Complete Adjuvant was mixed immediately before use with an equal volume of physiological saline. This 50 % adjuvant solution was administered to the animals by intradermal injection.
For the dermal and intradermal treatments, Reaktiv-Gelb F-66 923 FW was applied in isotonic saline [percentages w/v].
For the intradermal injections of the test substance in 50 % Freund's adjuvant, Reaktiv-Gelb F-66 923 FW was diluted with isotonic saline and then mixed with an equal volume of Freund's Original Adjuvant [percentages w/v].
The concentrations for the maximization test cannot be standardized. Suitable concentrations are established in preliminary tests. The selected concentration of the test substance depends on the individual phases of the study.
Determination of the primary non-irritant concentration: In a dermal-occlusive test for primary skin irritation, each of the following test concentrations was applied to the left flank of two guinea pigs:
25 % in isotonic saline
5 % in isotonic saline
1 % in isotonic saline
The hair on the left flank of the animals was removed mechanically. 0.5 ml of the test substance preparation was applied to a 2 x 2 cm cellulose patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema.
Determining of the tolerance of intradermal injections: To determine the tolerance of intradermal injections, each of the following pre-parations was administered twice by interdermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder. - Challenge controls:
- Dermal challenge treatment:
One area of approx. 5 x 5 cm on the left flank was shaved mechanically.
0.5 ml of the test substance preparation was applied to a 2 x 2 cm cellulose patch. The application area was then kept for 24 hours under an occlusive bandage with an impermeable film and an elastic bandage.
Treated and control groups (left flank): 25 % Reaktiv-Gelb F-66 923 FW in isotonic saline - Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Vehicle:
- other: not applicable
Results and discussion
- Positive control results:
- Not applicable.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Erythema reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Erythema reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Oedema reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Oedema reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Erythema reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Erythema reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Oedema reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Oedema reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Erythema reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Erythema reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Oedema reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Oedema reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Erythema reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Erythema reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Oedema reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Oedema reactions.
In vivo (LLNA)
Results
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
Any other information on results incl. tables
Determination of the primary non-irritant concentration
No signs of irritation occurred after application of the different test concentrations .
Treatment of the animals with Freund's Adjuvant can lower the threshold value for primary i rritation determined in pre!imi nary tests. For this reason, the five animals in the escort group which had been treated with Freund's Adjuvant were treated with 25%Reaktiv-Gelb F-66 923 FW in isotonic saline. As no reactions were observed in these animals, a concentration of 25%Reaktiv-Gelb F-66 923 FW in isotonic saline was chosen for the challenge at day 22.
Tolerance of intradermal injections
The intradermal injections with the 0.2%preparation caused no irritations.
Very slight oedema as well as barely perceptible erythema occurred after application of the 1%preparation.
The intradermal injections with the 5%preparation revealed very slight up to
well-defined erythema as well as very slight to slight oedema.
Additonally encrusted injection sites were observed after application of the 5 %
preperation.
Furthermore the intrademal injections with 0.2 %, 1 % and 5 % preparations were discoloured light yellow.
Based on this preliminary test, a 5 % preparation was selected for the intradermal injections in the main test.
Main test for sensitizing properties
Body weight gains and clinical signs
The treated animals showed no clinical signs of intoxication throughout the study.
The intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and oedema as wel 1 as indurated and encrusted skin. The intradermal injections with the test substance in the vehicle caused very slight up to slight oedema as well as well-defined erythema. The intradermal applications of the vehicle caused no signs of irritation. Additionally the application sites treated with the test substance in Freund's Adjuvant and in the vehicle showed yellowish discolourations.
Due to these strong irritation reaction of the skin, 10% sodium dodecylsulfate was not applied at day 7.
After the removal of the patch at day 10, erythema and oedema, scabbed and encrusted skin as well as necrosis and open wounds were observed at the sites previously treated with Freund's Adjuvant. The injection sites treated with the test substance in the vehicle and the vehicle alone showed no signs of irritation. Additionally light yellow discoloured skin was noted in the animals of the treatment group.
The body weight gains of the treated animals were not impaired.
Challenge treatment
No signs of irritation were observed 24 and 48 hours after removal of the occlusive bandage in the control group and in the treated group.
Treated area: left flank
Time of observation: 48 hours after treatment |
||||||||||
Scoring of dermal reactions |
||||||||||
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Yellowish discoloured |
X |
X |
X |
X |
X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Yellowish discoloured |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Time of observation: 72 hours after treatment |
||||||||||
Scoring of dermal reactions |
||||||||||
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Yellowish discoloured |
X |
X |
X |
X |
X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Yellowish discoloured |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
None of the treated animals showed a positive reaction during the observation period after the challenge
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Reaktiv-Gelb F-66 923 FW showed no evidence for sensitising properties. - Executive summary:
The objective of the test procedure described here is to determine the potential sensitising properties of a substance.
This study was conducted in compliance with EC-Guideline B.6. Acute Toxicity Sensitisation of the Skin of the Directive 92/69/EEC and OECD-Guideline for testing of chemicals, 406 "Skin Sensitisation". Study conducted in compliance with GLP.
Testing for sensitising properties of Reaktiv-Gelb F-66 923 FW was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 5.0 % Reaktiv-Gelb F-66 923 FW in isotonic saline. Dermal induction and challenge treatment were carried out with 25 % Reaktiv-Gelb F-66 923 FW in isotonic saline.
No signs of irritation occurred after application of the different test concentrations . Treatment of the animals with Freund's Adjuvant can lower the threshold value for primary irritation determined in preliminary tests. For this reason, the five animals in the escort group which had been treated with Freund's Adjuvant were treated with 25% Reaktiv-Gelb F-66 923 FW in isotonic saline. As no reactions were observed in these animals, a concentration of 25% Reaktiv-Gelb F-66 923 FW in isotonic saline was chosen for the challenge.
The treated animals showed no clinical signs of intoxication throughout the study.
No signs of irritation were observed 24 and 48 hours after removal of the occlusive bandage in the control group and in the treated group.
Based on the results of this study there is no evidence for sensitising properties of Reaktiv-Gelb F-66 923 FW.
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