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EC number: 292-588-2 | CAS number: 90640-67-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
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- Flash point
- Auto flammability
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- 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:
- August 4-19,1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- stability/purity not reported
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- EC Number:
- 292-588-2
- EC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Cas Number:
- 90640-67-8
- Molecular formula:
- C6H18N4, C8H20N4
- IUPAC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Amount received: 662.77 g (gross weight)
- pH: 8 (litmus paper)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Denver, PA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.325-2.607 kg
- Housing: Rabbits were housed individually in cages sized in accordance with the ''Guide for the Care and Use of Labolatory Animals'' of the Institute of National Research Council.
- Diet: Purina Lab Rabbit Chow (H.F.) ad libitum
- Water:fresh tap water, ad libitum
- Acclimation period: minimum 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3 (63°-73°F)
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light):12h light, 12h dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/site (6 cm²) - Duration of treatment / exposure:
- The test article was administrated once per site:
3 min, 60 min, 4h, 24 h - Observation period:
- 14d
- Number of animals:
- Six (6) :3♂ and 3♀
- Details on study design:
- TEST SITE
- Area of exposure: 5 sites on the dorsal trunk
- Type of wrap if used: impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): by using water and a gauze
- Time after start of exposure: 3 min, 60 min, 4h, 24h
SCORING SYSTEM:
Draize Evaluation of Dermal Irritation, Primary Irritation Index
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 4h exposure
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis at 24 hour reading time point in 5/6 animals
- Irritation parameter:
- erythema score
- Remarks:
- 3-minute exposure
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis in all animals
- Irritation parameter:
- edema score
- Remarks:
- 3-minute exposure
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis in all animals
- Irritant / corrosive response data:
- animals have been exposed for 60min, 4h, and 24h. All animals scored 4 (necrosis) for erythema and edema immediately after unwrapping.
Severe erythema and severe edema remained present in all animals at all observation periods during the study (up to 14 days).
Any other information on results incl. tables
Animal No. | Sex | Body Weight Initial (kg) | Body weight Final (kg) |
1 | M | 2.405 | 2.752 |
2 | M | 2.514 | 2.707 |
3 | M | 2.387 | 2.673 |
4 | F | 2.591 | 2.847 |
5 | F | 2.607 | 2.903 |
6 | F | 2.325 | 2.495 |
Table 1: 3-minute exposure |
|
|
||||||||
Rabbit/sex sex |
0 hours* |
24 hours |
48 hours |
72 hours |
Day 4 - 14 |
|||||
|
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
1M |
2 |
0 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
2M |
1 |
0 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
3M |
2 |
0 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4F |
1 |
0 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
5F |
0 |
0 |
1 |
0 |
2 |
0 |
4N |
4 |
4N |
4 |
6F |
2 |
0 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
mean |
1.3 |
0 |
3.5 |
3.3 |
3.7 |
3.3 |
4 |
4 |
4 |
4 |
Mean erythema 24/48/72h |
3.7 |
|||||||||
Mean edema 24/48/72h |
3.5 |
|||||||||
*: immediately after unwrap N = Necrosis |
|
|
Table 2: 60-minute, 4-hour and 24-hour exposure |
|
|
||||||||
Rabbit/sex sex |
0 hours* |
24 hours |
48 hours |
72 hours |
Day 4 - 14 |
|||||
|
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
1M |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
2M |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
3M |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4F |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
5F |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
6F |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
4N |
4 |
mean |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
Mean erythema 24/48/72h |
4.0 |
|||||||||
Mean edema 24/48/72h |
4.0 |
|||||||||
*: immediately after unwrap N = Necrosis |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1B (H314) according to Regulation (EC) No 1272/2008
- Conclusions:
- The test article was considered to be severe dermal irritant at both 4 and 24 hour exposures.
The Dermal Irritation Toxicity Category is Class I (corrosive).
The DOT Packing Group Classification is Class I (corrosive at less than 3 min).
Primary Dermal Irritation Index at 4h and 24h exposure=8.00 (according to Draize scoring system).
No reading time point at 1 hour after 3-minute exposure was available in order to definetly find a conclusion on subcategory 1A or 1B. Since after immediate observation after 3-minute exposure well-defined erythema (score 2) was found in 3 out of 6 animals it is not assumed that after on hour necrosis would have been formed. Therefore, a classification category 1B is considered. - Executive summary:
The test substance was examined undiluted for skin irritation in groups of 3 rabbits per sex. The test material was applied (semi-occlusive) directly on the intact and abraded skin sites. The skin was abraded using a burred needle, the abrasion penetrated the stratum corneum, but not the derma. The test article was administrated once per site for 3 min, 60 min, 4h, or 24 h. Necrosis was observed after 3 min exposure. The animals that had been exposed for 60 min, 4 h, or 24h scored 4 (necrosis) for erythema and edema immediately after unwrapping. Severe erythema and severe edema remained present in all animals at all observation periods during the study (up to 14 days).
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