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EC number: 268-610-1 | CAS number: 68131-13-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-06-08 to 2012-11-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Naphthenic acids, reaction products with diethylenetriamine
- EC Number:
- 268-610-1
- EC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Cas Number:
- 68131-13-5
- Molecular formula:
- not applicable
- IUPAC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Details on test material:
- Name: Naphthenic acids, reaction products with diethylenetriamine
CAS No.: 68131-13-5
Batch No.: ESD0011831
Certificate of Analysis: 26.05.2011 (see Appendix)
Chemical Name: Naphthenic acids, reaction products with diethylenetriamine
Physical State at RT: liquid (highly viscous)
Density: 0.978 g/cm3 (20°C, DIN EN ISO 12185)
Colour: brown
Expiry Date: 04/2013
Purity: 100% (UVCB substance)
Storage Conditions: at room temperature
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. XX)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. XX)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Preparation of the Animals:
The animals were marked for individual identification by tail painting.
Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals.
Application:
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner. - Duration of exposure:
- The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item was removed.
- Doses:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not required
- Details on study design:
- Observation period:
All animals were observed for 14 days after dosing
Weight Assessment:
The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
Clinical Examination:
careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given
during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions,
salivation, diarrhoea, lethargy, sleep and coma.
Pathology:
At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial) at the dosage of approximately 8 mL/kg bw. All animals were subjected to gross necropsy. All gross pathological changes were recorded and in case of findings the tissues were preserved for a possible histopathological evaluation. The preserved tissues of which no histopathological
evaluation was made will be discarded 3 months after the release of the final report unless otherwise agreed upon with the sponsor.
Evaluation of Results:
Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by sex and dose level.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.
Necropsy findings were described. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the
results is not regarded as necessary.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No treatment-related effects were observed.
- Gross pathology:
- No treatment-related effects were observed.
- Other findings:
- Erythema grade 1 and 2 were observed in 5 of 5 male and 5 of 5 female animals. Oedema grade 1 was observed in 3 of 5 male and 4 of 5 female
animals. Oedema grade 2 was observed in 1 of 5 female animals. Eschar was observed in 5 of 5 male and 5 of 5 female animals. Wound was
observed in 2 of 5 male and 3 of 5 female animals. Necrosis was observed in 1 of 5 female animals.
All signs of irritation were not fully reversible within the observation period.
Any other information on results incl. tables
Table Clinical Signs of Systemic Toxicity – Individual Data - Males:
Animal |
Time of |
Observations (for Signs of Dermal Irritation, see Table 5) |
21/ male / |
during the whole observation period |
no signs of toxicity |
22/ male / |
during the whole observation period |
no signs of toxicity |
23/ male / |
during the whole observation period |
no signs of toxicity |
24/ male / |
during the whole observation period |
no signs of toxicity |
25/ male / |
during the whole observation period |
no signs of toxicity |
min = minute(s), h = hour(s), bw = body weight
Table Clinical Signs of Systemic Toxicity – Individual Data – Females:
Animal |
Time of |
Observations (for Signs of Dermal Irritation, see Table 6) |
26/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
27/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
28/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
29/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
30/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
min = minute(s), h = hour(s), bw = body weight
Table Skin Irritation – Individual Data – Males:
Day after Start of Application |
Animal No. 21 |
Animal No. 22 |
Animal No. 23 |
Animal No. 24 |
Animal No. 25 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
2/0 |
nsf |
1/0 |
nsf |
2/1 |
nsf |
2/1 |
nsf |
2/1 |
nsf |
day 3 |
2/0 |
nsf |
2/0 |
nsf |
2/1 |
nsf |
2/1 |
nsf |
2/1 |
nsf |
day 4 |
2/0 |
nsf |
2/0 |
nsf |
2/1 |
nsf |
2/1 |
nsf |
2/1 |
nsf |
day 5 |
2/0 |
nsf |
2/0 |
nsf |
2/1 |
nsf |
2/1 |
nsf |
2/1 |
Es |
day 6 |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es, W(10) |
2/0 |
Es, W(15) |
day 7 |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es, W(10) |
2/0 |
Es, W(10) |
day 8 |
1/0 |
Es |
2/0 |
Es |
2/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 9 |
1/0 |
Es |
2/0 |
Es |
2/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 10 |
1/0 |
Es |
1/0 |
Es |
2/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 11 |
1/0 |
Es |
1/0 |
Es |
2/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 12 |
1/0 |
Es |
1/0 |
Es |
2/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 13 |
1/0 |
Es |
0/0 |
Es |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 14 |
1/0 |
Es |
0/0 |
Es |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 15 |
1/0 |
Es |
0/0 |
Es |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) Es = eschar; W (Ømm) = wound; nsf = no specific findings
|
Table Skin Irritation – Individual Data – Females:
Day after Start of Application |
Animal No. 26 |
Animal No. 27 |
Animal No. 28 |
Animal No. 29 |
Animal No. 30 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
2/0 |
nsf |
2/1 |
nsf |
1/0 |
nsf |
2/0 |
nsf |
2/1 |
nsf |
day 3 |
2/1 |
nsf |
2/2 |
nsf |
1/0 |
nsf |
2/1 |
* |
2/1 |
nsf |
day 4 |
2/1 |
nsf |
2/2 |
nsf |
1/0 |
nsf |
2/1 |
* |
2/1 |
nsf |
day 5 |
2/1 |
nsf |
2/0 |
Es, |
1/0 |
nsf |
2/1 |
* |
2/1 |
nsf |
day 6 |
2/0 |
N (15) |
2/1 |
Es, |
2/0 |
Es, |
2/1 |
Es, * |
2/0 |
W (2.5 cm) |
day 7 |
2/0 |
N (15) |
2/1 |
Es, |
2/0 |
Es, |
2/1 |
Es, * |
2/0 |
W (2.5 cm) |
day 8 |
2/0 |
N (15) |
2/0 |
Es |
2/0 |
Es |
2/1 |
Es, * |
2/0 |
W (2.5 cm) |
day 9 |
2/0 |
Es, N (15) |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es, * |
2/0 |
W (2.5 cm) |
day 10 |
2/0 |
Es, N (15) |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es, * |
2/0 |
Es, |
day 11 |
2/0 |
Es, N (15) |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es, |
day 12 |
2/0 |
Es, N (15) |
2/0 |
Es, |
2/0 |
Es |
2/0 |
Es |
2/0 |
Es |
day 13 |
1/0 |
Es |
2/0 |
Es, |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 14 |
1/0 |
Es |
1/0 |
Es, |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
day 15 |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
1/0 |
Es |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) Es = eschar; N (Ømm) = necrosis; W (Ø) = wound; nsf = no specific findings; * = animal very nervous
|
Table Absolute Body Weights in g and Body Weight Gain in %:
Dose: 2000 mg/kg body weight |
||||
Animal No. / Sex |
g |
g |
g |
% |
21 / male |
238 |
243 |
276 |
16 |
22 / male |
245 |
262 |
291 |
19 |
23 / male |
232 |
220 |
249 |
7 |
24 / male |
231 |
230 |
261 |
13 |
25 / male |
241 |
238 |
261 |
8 |
26 / female |
223 |
220 |
220 |
-1 |
27 / female |
211 |
198 |
209 |
-1 |
28 / female |
210 |
205 |
215 |
2 |
29 / female |
221 |
214 |
220 |
0 |
30 / female |
212 |
205 |
216 |
2 |
Table Macroscopic Findings - Individual Data – Males and Females:
Dose: 2000 mg/kg bw |
||
Animal No. / |
Organ |
Macroscopic Findings |
21 / male |
- |
nsf |
22 / male |
- |
nsf |
23 / male |
- |
nsf |
24 / male |
- |
nsf |
25 / male |
liver |
liver partially located in thorax |
26 / female |
- |
nsf |
27 / female |
- |
nsf |
28 / female |
- |
nsf |
29 / female |
- |
nsf |
30 / female |
- |
nsf |
nsf = no specific findings
Table LD50:
Dose (Unit)
|
Number of Animals Investigated |
Number of Intercurrent Deaths |
LD50 |
2000 mg/kg bw |
5 males |
0 |
> 2000 mg/kg bw |
2000mg/kg bw |
5 females |
0 |
> 2000 mg/kg bw |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, single dermal application of NA-DETA to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity but signs of irritation.
The dermal LD50 was determined to be > 2000 mg/kg body weight. - Executive summary:
The acute dermal toxicity of NA-DETA was investigated according to the Guideline OECD 402.
NA-DETA was applied dermally to rats at dose level of 2000 mg/kg body weight. No mortality, no signs of toxicity was observed.
The dermal LD50 was determined to be > 2000 mg/kg body weight.
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