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Diss Factsheets
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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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- venlafaxin 2nd intermediate (amino-hexanol)
- IUPAC Name:
- venlafaxin 2nd intermediate (amino-hexanol)
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Husbandry:
Number of animal room: 618
Housing: Animals were housed individually in metal cages
Lighting periods: 12 hours daily, from 6.00 am to 6.00 pm
Temperature: 20±3°C
Relative humidity: 50±20%
Food and feeding
Animals received UNIPLUS standard diet for rabbits produced by AGRIBRANDS Europe, Karcag, Kunmadarasi street, Hungary, ad libitum.
Water supply
Animals received tap water as for human consumption ad libitum from automatic self supplying water system.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of each animal served as a control
- Amount / concentration applied:
- 0.5g of venlafaxin 2nd intermediate
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals were examined for signs of erythema and edema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours, 1 and 2 weeks after the patch removal.
- Number of animals:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- ca. 2.16
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- In the first hour after the patch removal in two animals (No.: 8090 and 8095) moderate, in one animal (No.: 8076) well defined erythema was observed. In every treated animal very slight edema occurred.
In 24 hours after the patch removal in one animal (No.: 8090) severe erythema was observed. Severe necrosis, black coloured area was found on the treated skin surface. In one animal (No.8095) moderate, in one animal (No.8076) well defined erythema were observed.
In 48 hours after the patch removal in every treated animal very slight erythema was observed. Severe necrosis, black coloured dry and hard area was found in two animals (No.:8090 and 8095) and in one rabbit (No.:8076) the treated skin surface was dry and hard.
In the 72 hours after the patch removal in every treated animal very slight erythema was observed. The treated skin surface was dry and hard, desquamation began.
At the first week after the patch removal the erythema abated in every treated animal. In two cases (No. 8076, 8095) advanced desquamation was observed. In one animal No.: 8090 the treated skin surface was black, dry and hard. In this case starting desquamation was found.
At the second week after the patch removal no erythema or edema were observed on the treated skin surface, the eschar formation peeled and the necrosis recovered. The skin irritation effect of the test item proved to be reversible.
Any other information on results incl. tables
Classification of Test Items
Index of treated skin: (A+ B)I(NXT)=c
A= total score of erythema
B = total score of edema
N =animal number
T = number of scoring, when the score is not zero
C = irritation index
0 - 0.5 non irritant
0.6 - 3.0 slightly irritant
3.1- 5.0 moderately irritant
5.1 - 8.0 severely irritant
SCORING OF ERYTHEMA FORMATION
Table 1
Animal N°/ Sex |
1 h |
24 h |
48 h |
72 h |
7 d |
14d |
8090/M |
3 |
4 |
1 |
1 |
0 |
0 |
8095/M |
3 |
3 |
1 |
1 |
0 |
0 |
8076/M |
2 |
2 |
1 |
1 |
0 |
0 |
TOTAL / A |
8 |
9 |
3 |
3 |
0 |
0 = 23 |
SCORING OF EDEMA FORMATION
Table 2
Animal N°/ Sex |
1 h |
24 h |
48 h |
72 h |
7 d |
14d |
8090/M |
1 |
0 |
0 |
0 |
0 |
0 |
8095/M |
1 |
0 |
0 |
0 |
0 |
0 |
8076/M |
1 |
0 |
0 |
0 |
0 |
0 |
TOTAL / B |
3 |
0 |
0 |
0 |
0 |
0 = 3 |
INDEX of skin irritation: (A(23)+B(3))I12=C(2.16)
M=male
d =day
h =hour
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Venlafaxin 2nd Intermediate was judged as irritant.
According to Regulation (EC) n. 1272/2008 and Directive 67/548/EEC, the substance should be classified as skin irritant 2 H315 and as Xi R38.
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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