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EC number: 603-392-7 | CAS number: 130198-05-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to recommended guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Freund's complete adjuvant test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Husbandry
Animal health: Only animals in acceptable health condition were used for the test. It is certified by the veterinarian
Cage type: Animals were housed in macrolon cages, size III, with 3 or 2 animals/cage ( 42 x 42 x 19 cm)
Bedding: laboratory bedding
Animal room: 614
Light: 12 hours daily from 6 a.m. to 6 p.m. (artificial light)
Temperature: 20 ±3°C
Relative humidity: 30-70%
Rate of air exchange: 13-17 hours
Food and Feeding
Animals received UNIPLUS standard diet for rabbits produced by AGRIBRANDS Europe Hungary, ad libitum.
Water Supply
The animals received tap water, as for human consumption, ad libitum containing 50 mg/100mL Ascorbic acid. - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- NaCl 0.9%
- Concentration / amount:
- Series of test item concentrations were tested to specify the primary irritation by intradermal injection and dermal application. Four dose levels were tested in the preliminary dose range finding study to specify the primary irritation by intradermal injection and four dose levels by dermal application.
The test item was applied in concentrations of 0.1, 1, 5, 10, 25, 50 and 75% (w/v).
For the intradermal application 0.1 mL formulated test item was injected in concentrations of 0.1, 1, 5 and 10% (w/v). Two different concentrations were applied
per animal to the hairless skin on the right and left flanks, and two animals were employed per concentration tested.
For the dermal application 0.5 mL formulated test item was applied onto the skin of the animals in concentrations of 10, 25, 50, 75% (w/v). A closed patch exposure was employed by means of an occlusive bandage. Two animals/ two different concentrations were used.
It was found that 0.5 mL of test formulation in concentrations of 10, 25 and 50% produced no reaction on the skin of guinea pigs. In concentration of 75% very slight and well defined erythema occurred one hour after the patch removal. - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Remarks:
- NaCl 0.9%
- Concentration / amount:
- Series of test item concentrations were tested to specify the primary irritation by intradermal injection and dermal application. Four dose levels were tested in the preliminary dose range finding study to specify the primary irritation by intradermal injection and four dose levels by dermal application.
The test item was applied in concentrations of 0.1, 1, 5, 10, 25, 50 and 75% (w/v).
For the intradermal application 0.1 mL formulated test item was injected in concentrations of 0.1, 1, 5 and 10% (w/v). Two different concentrations were applied
per animal to the hairless skin on the right and left flanks, and two animals were employed per concentration tested.
For the dermal application 0.5 mL formulated test item was applied onto the skin of the animals in concentrations of 10, 25, 50, 75% (w/v). A closed patch exposure was employed by means of an occlusive bandage. Two animals/ two different concentrations were used.
It was found that 0.5 mL of test formulation in concentrations of 10, 25 and 50% produced no reaction on the skin of guinea pigs. In concentration of 75% very slight and well defined erythema occurred one hour after the patch removal. - No. of animals per dose:
- Test group: 10 animals
Control group: 5 animals - Challenge controls:
- 24 hours before the challenge treatment the left and the right flank areas (5x5 cm) of each animal were prepared for application. The challenge was performed as a dermal exposure (Closed Patch Test).
Left shaved flank areas of the animals (both the test and the control) were treated with 0.50 ml of the test item (in concentration 50%). The right shaved flank areas were treated with 0.50 ml of distilled water, in all cases. Time of exposure was 24 hours. - Positive control substance(s):
- yes
- Positive control results:
- 5 control animals were exposed to vehicle during induction treatment and they were treated with the reference item on the challenge day only. No visible changes were found at the 241 h and 481 h hour examinations. During the challenge exposure, the reference item POTASSIUM DICHROMATE (in concentration of 0.3%) did not evoke primary irritation.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Venlafaxin 2nd Intermediate is considered not sensitising.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for skin sensitisation.
Reference
Dermal symptoms of guinea pigs challenged with test item venlafaxin2ndintermediate
Table 2
TEST ANIMALS
Animal number |
SKIN REACTION |
|||
24 hours |
|
48 hours |
|
|
after the patch removal |
||||
left side |
right side |
left side |
right side |
|
112 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
128 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
132 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
147 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
151 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
106 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
107 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
129 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
130 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
131 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
Abbreviations: n.v.c. = no visible change
Dermal symptoms of guinea pigs challenged with test
item venlafaxin2ndintermediate
Table 3
CONTROL ANIMALS
Animal number |
SKIN REACTION |
|||
24 hours |
48 hours |
|||
after the patch removal |
||||
|
left side |
right side |
left side |
right side |
133 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
135 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
136 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
137 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
138 |
n.v.c |
n.v.c |
n.v.c |
n.v.c |
Abbreviations: n.V.C. = no visible change
Dermal response scores+ for guinea pigs challenged with
test item venlafaxin2"dintermediate
(Challenge concentration: in concentration Table 4
TEST ANIMALS CONTROL ANIMALS
Animal number |
Score of dermal reaction |
Animal number |
Score of dermal reaction |
||
|
24 hours |
48 hours |
|
24 hours |
48 hours |
|
after the patch removal |
|
after the patch removal |
||
112 |
0 |
0 |
133 |
0 |
0 |
128 |
0 |
0 |
135 |
0 |
0 |
132 |
0 |
0 |
136 |
0 |
0 |
147 |
0 |
0 |
137 |
0 |
0 |
151 |
0 |
0 |
138 |
0 |
0 |
106 |
0 |
0 |
- |
- |
- |
107 |
0 |
0 |
- |
- |
- |
129 |
0 |
0 |
- |
- |
- |
130 |
0 |
0 |
- |
- |
- |
131 |
0 |
0 |
- |
- |
- |
mean of scores |
0.00 |
0.00 |
mean of scores |
0.00 |
0.00 |
number of positive/number of tested |
0/10 |
0/10 |
number of positive/number of tested |
0/5 |
0/5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test item Venlafaxin 2nd Intermediate is considered not sensitising.
Migrated from Short description of key information:
The test item does not show any visible change after 24 hours and 48 hours after the patch removal.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for skin sensitisation.
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