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EC number: 437-450-6 | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 April 1999 to 7 May 1999.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 437-450-6
- EC Name:
- -
- Cas Number:
- 64654-05-3
- Molecular formula:
- Hill formula: C28 H37 N
- IUPAC Name:
- N-(dodecylphenyl)naphthalen-1-amine
- Test material form:
- liquid: viscous
- Details on test material:
- Sponsor's identification: APAN
Description: redbrown viscous liquid
Lot number: EL01010B01/KZ8911.5
Storage conditions: room temperature in the dark
1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White rabbits supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.68 to 3.01 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- At each test site a quantity of 0.5 ml of the test material was introduced.
- Duration of treatment / exposure:
- One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application.
- Observation period:
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
- Number of animals:
- 3
- Details on study design:
- On the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
One rabbit was initially treated. Three suitable test sites were selected on the back of the rabbit. At each test site a quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animal was returned to its cage for the duration of the exposure period.
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in 74% industrial Methylated Spirits.
After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 ml of test material. One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 4-Hour Exposure Period
Very slight erythema was noted at one treated skin site at the 24 and 48-hour observations. No other signs of dermal irritation were noted during the study.
1-Hour Exposure Period
Very slight erythema was noted at the treated skin site at the 24 and 48-hour observations. The treated skin site appeared normal at the 72-hour observation.
3-Minute Exposure Period
No signs of dermal irritation were noted during the study. - Other effects:
- No further effects detailed in the study report.
Any other information on results incl. tables
INDIVIDUAL SKIN REACTIONS FOLLOWING 4-HOUR EXPOSURE PERIOD
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex (Bodyweight kg) |
Total |
||
184 Female (2.78) |
170 Female (2.68) |
215 Female (3.01) |
|||
Erythema/Eschar Formation |
1 Hour 24 Hours 48 Hours 72 Hours |
0 1 1 0 |
0 0 0 0 |
0 0 0 0 |
(0) 1 (1) 0 |
Oedema Formation |
1 Hour 24 Hours 28 Hours 72 Hours |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
(0) 0 (0) 0 |
Sum of 24 and 72-hour Readings (S) |
: |
1 |
|||
Primary Irritation Index (S/6) |
: |
1/6 – 0.2 |
|||
Classification |
: |
MILD IRRITANT |
( ) – Total values not used for calculation of primary irritation index
INDIVIDUAL DAILY AND MEAN SCORES FOR DERMAL IRRITATION FOLLOWING 4-HOUR EXPOSURE REQUIRED
FOR EU LABELLING REGULATIONS
Skin Reaction |
Reading (Hours) |
Individual Scores – Rabbit Number and Sex (Bodyweight kg) |
||
184 Female (2.78) |
170 Female (2.68) |
215 Female (3.01) |
||
Erythema/Eschar Formation |
24 48 72 |
1 1 0 |
0 0 0 |
0 0 0 |
Total |
|
2 |
0 |
0 |
Mean Score |
|
0.7 |
0.0 |
0.0 |
Oedema Formation |
24 48 72 |
0 0 0 |
0 0 0 |
0 0 0 |
Total |
|
0 |
0 |
0 |
Mean Score |
|
0.0 |
0.0 |
0.0 |
INDIVIDUAL SKIN REACTIONS FOLLOWING 1-HOUR AND 3-MINUTE EXPOSURES
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex (Bodyweight kg) |
|
184 Female (2.78) |
|||
1-Hour Exposure |
3-Minute Exposure |
||
Erythema/Eschar Formation |
1 Hour 24 Hours 48 Hours 72 Hours |
0 1 1 0 |
0 0 0 0 |
Oedema Formation |
1 Hour 24 Hours 48 Hours 72 Hours |
0 0 0 0 |
0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, APAN, produced a primary irritation index of 0.2 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required. - Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 1 7 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treated skin sites appeared normal at the 72-hour observation. No corrosive effects were noted.
3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.
The test material produced a primary irritation index of 0.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.
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