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EC number: 432-080-1 | 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 November 1998 to 25 December 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to recent EU & OECD test guidelines in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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:
- - Name of test material (as cited in study report): Reaktiv-Orange DYPR 1410
- Physical state: Orange powder
- Analytical purity: 72%
- Purity test date: December 15, 1998
- Lot/batch No.: DYPR 1410
- Expiration date of the lot/batch: August 2003
- Storage condition of test material: darkness at approximately 5C in a refrigerator
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Species / sex: Pirbright-White guinea pig / female
Strain: HsdPocDH
Origin: HARLAN WINKELMANN Gartenstr. 27 D-33178 Borchen SPF breeding colony
Body weight at start of study: mean = 391g (=100 %)
min = 329g (-15.6%)
max = 417g (+6.7%)
n = 15
Randomization: Randomization scheme 98.0744
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
Room temperature: 20 ± 3°C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Acclimatization: at least 7 days
Food: ssniff® Ms-H (V2233), ad libitum
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:
- water
- Concentration / amount:
- Treatment Group:
Appl.vol. Conc. Vehicle
2 x 0.1ml - 50% Freund’s Adjuvent
2 x 0.1ml 5% Substance in deionised water
2 x 0.1ml 5% Substance in 50% Freund’s Adjuvent
Control Group:
Appl. Vol. Vehicle
2 x 0.1ml 50% Freund’s Adjuvent
2 x 0.1ml Deionised water
2 x 0.1ml Equal volume of deionised water and 50% Freund’s Adjuvant
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Treatment Group:
Appl.vol. Conc. Vehicle
2 x 0.1ml - 50% Freund’s Adjuvent
2 x 0.1ml 5% Substance in deionised water
2 x 0.1ml 5% Substance in 50% Freund’s Adjuvent
Control Group:
Appl. Vol. Vehicle
2 x 0.1ml 50% Freund’s Adjuvent
2 x 0.1ml Deionised water
2 x 0.1ml Equal volume of deionised water and 50% Freund’s Adjuvant
- No. of animals per dose:
- Test group Number of animals
Determination of the primary non-irritant concentration 3
Determination of the tolerance of the intradermal injections 2
Control group 5
Treatment group 10
10 animals in the treatment group and 5 animals in the control group were used. One animal of the treatment group were found dead at day 10 of the study. - Details on study design:
- The following preparations were used for the intradermal injections:
Control group:
50 % Freund's Complete Adjuvant emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed immediately before use with an equal volume of deionized water.
Deionized water
50 % Freund's Complete Adjuvant emulsion mixed with an equal volume of the vehicle
Treatment group:
50 % Freund's Complete Adjuvant emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed immediately before use with an equal volume of deionized water.
5 % Reaktiv-Orange DYPR 1410 in deionized water
5 % Reaktiv-Orange DYPR 1410 in a 50 % Freund's Complete Adjuvant emulsion
For the intradermal injections of the test substance in 50 % Freund's adjuvant, Reaktiv-Orange DYPR 1410 was dissolved in deionized water and then mixed with an equal volume of Freund's Original Adjuvant [percentages w/v].
For the dermal treatments, Reaktiv-Orange DYPR 1410 was dissolved in deionized water [percentages w/v].
Determination of the primary non-irritant concentration
Prior to the determination of the primary non-irritation concentration in a dermal-occlusive test the animals received 4 intradermal injections of a 50% Freund's Complete Adjuvant emulsion (4 x 0.1 ml) into the dorsal area, since Freund's Complete Adjuvant may lower the threshold of primary irritation. Thereafter, each of the following test concentrations was administered to the flanks of three guinea pigs:
25.0 % in deionized water
5.0 % in deionized water
1.0 % in deionized water
The hair on the flanks of the animals was removed mechanically. 0.5 ml of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the 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.
Determination of the tolerance of the intradermal injections
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 2 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 shoulders.
24, 48, 72 and 96 hours after administration the injection sites were examined for local tolerance. - Challenge controls:
- Control Group:
Appl. Vol. Vehicle
2 x 0.1ml 50% Freund’s Adjuvent
2 x 0.1ml Deionised water
2 x 0.1ml Equal volume of deionised water and 50% Freund’s Adjuvant - Positive control substance(s):
- yes
- Remarks:
- Benzocain; periodically conducted positive control test
Study design: in vivo (LLNA)
- Vehicle:
- other: Not applicable
Results and discussion
- Positive control results:
- Testing for sensitizing properties of Benzocain was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN. This study is conducted periodically, and used as supporting evidence to the fact that the study methodology and approach is appropriate.
Intradermal induction was performed using 1 % Benzocain in sesame oil DAB 10. Dermal induction and challenge treatment were carried out with 25 % Benzocain in sesame oil DAB 10.
After the second challenge treatment four animals of the treatment group (40 %) showed a positive reaction during the observation period. The results obtained are typical for weak sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- 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: 9.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
In vivo (LLNA)
Results
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
Any other information on results incl. tables
First challenge treatment – control and treatment group
25% Reaktiv-Orange DYPR 1410 in deionised water
Treated area; left flank
Scoring of dermal reactions
Time of observation: approx. 24 hours after removal of the patches |
||||||||||||||||
Control animal No: |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
||||||
Value |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
||||||
Treated animal No.: |
6 |
7 |
8 |
9 |
10 |
11 |
12* |
13 |
14 |
15 |
||||||
Value |
0 |
0 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
||||||
Time of observation: approx. 48 hours after removal of the patches |
||||||||||||||||
Control animal No.: |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
||||||
Value |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
||||||
Treated animal No.: |
6 |
7 |
8 |
9 |
10 |
11 |
12* |
13 |
14 |
15 |
||||||
Value |
0 |
0 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
||||||
*Animal was found dead at day 10 of the study.
Second challenge treatment – control and treatment group
25% Reaktiv-Orange DYPR 1410 in deionised water
Treated area; left flank
Scoring of dermal reactions
Time of observation: approx. 24 hours after removal of the patches |
||||||||||||||||
Control animal No: |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
||||||
Value |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
||||||
Treated animal No.: |
6 |
7 |
8 |
9 |
10 |
11 |
12* |
13 |
14 |
15 |
||||||
Value |
0 |
0 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
||||||
Time of observation: approx. 48 hours after removal of the patches |
||||||||||||||||
Control animal No.: |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
||||||
Value |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
||||||
Treated animal No.: |
6 |
7 |
8 |
9 |
10 |
11 |
12* |
13 |
14 |
15 |
||||||
Value |
0 |
0 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
||||||
*Animal was found dead at day 10 of the study.
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 nine animals of the treatment group showed a positive skin response after the challenge procedure.
Thus, the percentage of animals reacting positive is below the threshold of 30 %.
Based on the results of this study Reaktiv-Orange DYPR 1410 showed no evidence for sensitizing properties - Executive summary:
The present study was conducted in compliance with EEC-Guideline B.6 "Acute Toxicity Sensitization of the Skin" of the Directive 96/54/EEC and OECD-Guideline for testing of chemicals, 406 "Skin Sensitization".
This study was conducted in compliance with GLP.
Testing for sensitizing properties of Reaktiv-Orange DYPR 1410 was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 5 % Reaktiv-Orange DYPR 1410 in deionized water. Dermal induction and challenge treatments were carried out with 25 % Reaktiv-Orange DYPR 1410 in deionized water.
The validity of the test system is confirmed by the periodically conducted positive control test using benzocain for the maximization test (report number 98.0490, dated June 30, 1998; Hoechst Marion Roussel, Preclinical Development Germany, Drug Safety).
One animal of the treatment group was found dead at day 10 of the study. But no substance related toxic effects was noted.
Under the conditions of the present study, none of nine animals of the treatment group showed a positive skin response after the challenge procedure.
Thus, the percentage of animals reacting positive is below the threshold of 30 %.
Based on the results of this study Reaktiv-Orange DYPR 1410 showed no evidence for sensitizing properties.
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.

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