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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- from gestation day 6 to gestation day 19 / per gavage
- Frequency of treatment:
- once per day
- Duration of test:
- until the cesarean section on gestation day 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 80 mg/kg bw/day
- Remarks:
- The treatment at 250 mg/kg/day was reduced to 80 mg/kg/day due to the apparent toxicity. The period of treatment at 250 mg/kg/day was at most four days at the beginning of the treatment.
- Dose / conc.:
- 40 mg/kg bw/day
- Remarks:
- The treatment at 120 mg/kg/day was reduced to 40 mg/kg/day due to the apparent toxicity. The period of treatment at 120 mg/kg/day was at most four days at the beginning of the treatment.
- Dose / conc.:
- 20 mg/kg bw/day
- Remarks:
- The treatment at 60 mg/kg/day was reduced to 20 mg/kg/day due to the apparent toxicity. The period of treatment at 60 mg/kg/day was at most four days at the beginning of the treatment.
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The dose selection was based on the dose-range-finding study, in which the animals were treated at volume of 10 mL/kg. In the presented main study the animals were treated at volume of 4 mL/kg, so that the test-item concentration of the applied formulation was in creased. In the presented main study, the animals exhibited clinical signs indicative of higher toxicity when compared to the dose-range finding study. After max. four days of exposure, the dose levels were reduced. The increased toxicity observed in the presented main study is likely to be associated with the local effects of the test-material, which in turn is likely to be associated with increased test-item concentration of the applied formulation.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Description (incidence and severity):
- one animal out of 21 pregnant animals at mid dose
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- not relevant
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 80 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 80 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
Any other information on results incl. tables
Summary of Clinical Signs, Physical examination and Mortality |
|||||
The animals were treated at dose of 0, 60, 120 and 250 mg/kg bw from the gestation day 5. After four days of treatment, the dose levels were reduced to 0, 20, 40, and 80 due to the severe maternal toxicity. |
|||||
|
Group No. |
G1 |
G2 |
G3 |
G4 |
Observations |
Dose (mg/kg/day) |
0 |
60/20 |
120/40 |
250/80 |
|
Total No. of rats found sperm positive |
24 |
24 |
24 |
24 |
Clinical signs and Physical examination |
|
|
|
|
|
Slight/moderate/severe salivation
|
0 |
0 |
7 |
11 |
|
Reddish nasal discharge |
0 |
0 |
2 |
7 |
|
Reddish eye discharge |
0 |
0 |
0 |
5 |
|
Moderate gasping |
0 |
0 |
0 |
1 |
|
Mortality |
0 |
0 |
0 |
1 |
Summary of maternal group mean body weight (g) |
|||||||||||
The animals were treated at dose of 0, 60, 120 and 250 mg/kg bw from the gestation day 5. After four days of treatment, the dose levels were reduced to 0, 20, 40, and 80 due to the severe maternal toxicity. |
|||||||||||
Group No. |
Dose (mg/kg/day) |
No. of Dams |
Group mean body weight (g) on day |
||||||||
|
0 |
3 |
5 |
8 |
11 |
14 |
17 |
20 |
|||
G1 |
0 |
21 |
Mean |
225.49 |
238.50 |
243.67 |
253.85 |
269.83 |
285.16 |
317.43 |
353.16 |
|
|
|
SD |
14.85 |
15.10 |
14.59 |
14.94 |
15.62 |
17.02 |
18.76 |
23.12 |
|
|
|
|
|
|
|
|
|
|
|
|
G2 |
60/20 |
21 |
Mean |
228.50 |
241.63 |
247.57 |
250.37 |
266.63 |
279.29 |
306.02 |
342.75 |
|
|
|
SD |
15.70 |
18.69 |
18.47 |
21.70 |
22.56 |
25.22 |
34.11 |
42.34 |
|
|
|
|
|
|
|
|
|
|
|
|
G3 |
120/40 |
21 |
Mean |
225.64 |
238.91 |
244.96 |
244.03 |
249.79* |
259.49* |
282.75* |
310.79* |
|
|
|
SD |
17.34 |
17.91 |
19.09 |
24.23 |
27.24 |
33.90 |
45.87 |
54.99 |
|
|
|
|
|
|
|
|
|
|
|
|
G4 |
250/80 |
21 |
Mean |
226.53 |
240.94 |
246.50 |
242.10 |
247.44* |
256.26* |
278.65* |
307.31* |
|
|
|
SD |
15.18 |
14.96 |
15.21 |
18.88 |
24.63 |
28.59 |
39.17 |
47.22 |
|
|
|
|
|
|
|
|
|
|
|
|
*: Significantly different from vehicle control group.
Summary of Food Intake (g/rat /day) |
||||||
The animals were treated at dose of 0, 60, 120 and 250 mg/kg bw from the gestation day 5. After four days of treatment, the dose levels were reduced to 0, 20, 40, and 80 due to the severe maternal toxicity. |
||||||
Period of treatment (days of gestation) |
Group No. |
G1 |
G2 |
G3 |
G4 |
|
Dose (mg/kg/day) |
0 |
60/20 |
120/40 |
250/80 |
||
No. of Dams |
21 |
21 |
21 |
21 |
||
Intermittent food intake |
|
|
|
|
|
|
|
|
|
|
|
|
|
0-3 |
|
Mean |
16.64 |
17.24 |
17.34 |
17.45 |
|
|
SD |
1.58 |
2.30 |
1.89 |
1.45 |
|
|
|
|
|
|
|
3-5 |
|
Mean |
18.56 |
18.98 |
19.28 |
19.14 |
|
|
SD |
1.63 |
1.92 |
2.29 |
1.73 |
|
|
|
|
|
|
|
5-8 |
|
Mean |
16.01 |
13.97 |
13.17* |
11.38* |
|
|
SD |
1.66 |
3.75 |
4.43 |
3.80 |
|
|
|
|
|
|
|
8-11 |
|
Mean |
18.46 |
17.13 |
14.62* |
12.66* |
|
|
SD |
1.46 |
3.19 |
4.47 |
5.94 |
|
|
|
|
|
|
|
11-14 |
|
Mean |
19.95 |
18.49 |
16.65* |
14.81* |
|
|
SD |
1.59 |
3.39 |
5.68 |
4.58 |
|
|
|
|
|
|
|
14-17 |
|
Mean |
22.28 |
20.83 |
18.92 |
17.91* |
|
|
SD |
2.58 |
5.11 |
6.64 |
6.19 |
|
|
|
|
|
|
|
17-20 |
|
Mean |
21.64 |
21.89 |
18.16 |
18.06 |
|
|
SD |
2.35 |
4.66 |
6.06 |
5.89 |
|
|
|
|
|
|
|
*: Significantly different from vehicle control group.
Summary of Maternal Data |
|||||
The animals were treated at dose of 0, 60, 120 and 250 mg/kg bw from the gestation day 5. After four days of treatment, the dose levels were reduced to 0, 20, 40, and 80 due to the severe maternal toxicity. |
|||||
|
Group No. |
G1 |
G2 |
G3 |
G4 |
Parameters |
Dose (mg/kg/day) |
0 |
60/20 |
120/40 |
250/80 |
|
No. of Dams |
21 |
21 |
21 |
21 |
|
|
|
|
|
|
Gravid uterine weight (g) |
Mean |
79.12 |
66.92 |
64.69 |
70.21 |
|
SD |
19.23 |
18.14 |
25.18 |
20.02 |
|
|
|
|
|
|
Number of Corpora lutea |
Mean |
16.52 |
15.48 |
15.90 |
17.05 |
SD |
2.52 |
2.50 |
2.21 |
2.04 |
|
|
|
|
|
|
|
Number of Implantations |
Mean |
14.43 |
12.86 |
13.86 |
14.81 |
SD |
3.64 |
3.53 |
2.92 |
2.23 |
|
|
|
|
|
|
|
Early Resorptions |
Mean |
0.67 |
0.76 |
1.62 |
0.95 |
SD |
0.80 |
1.04 |
3.20 |
1.63 |
|
|
|
|
|
|
|
Late Resorptions |
Mean |
0.19 |
0.48 |
0.52 |
0.62 |
SD |
0.68 |
0.98 |
1.78 |
1.91 |
|
|
|
|
|
|
|
Pre-implantation Loss |
Mean |
2.10 |
2.62 |
2.05 |
2.24 |
SD |
1.61 |
2.16 |
1.75 |
1.61 |
|
|
|
|
|
|
|
Post-implantation Loss |
Mean |
0.86 |
1.24 |
2.14 |
1.57 |
SD |
1.28 |
1.34 |
3.58 |
2.29 |
|
|
|
|
|
|
|
Dams with any Resorption
|
Total |
10
|
14
|
11
|
11
|
Dams with only implantation site |
Total |
0 |
0 |
1 |
0 |
(complete resorptions) |
|
|
|
|
|
Summary of Litter Data |
|||||
The animals were treated at dose of 0, 60, 120 and 250 mg/kg bw from the gestation day 5. After four days of treatment, the dose levels were reduced to 0, 20, 40, and 80 due to the severe maternal toxicity. |
|||||
|
Group No. |
G1 |
G2 |
G3 |
G4 |
Parameters |
Dose (mg/kg/day) |
0 |
60/20 |
120/40 |
250/80 |
|
No. of Dams |
21 |
21 |
21 |
21 |
|
|
|
|
|
|
No. of litters |
|
21 |
21 |
20 |
21 |
|
|
|
|
|
|
Total no. of fetuses |
|
285 |
244 |
246 |
278 |
|
|
|
|
|
|
Mean litter size |
|
13.6 |
11.6 |
12.1 |
13.2 |
|
|
|
|
|
|
Dead fetuses |
Total |
0 |
0 |
0 |
0 |
|
% |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
Total live fetuses |
|
|
|
|
|
a. Number |
|
285 |
244 |
246 |
278 |
|
|
|
|
|
|
b. Weight (g) |
Mean |
3.83 |
3.72 |
3.38 |
3.13* |
|
SD |
0.33 |
0.56 |
0.74 |
0.79 |
|
|
|
|
|
|
Live male fetuses |
|
|
|
|
|
a. Number |
|
137 |
129 |
121 |
140 |
|
|
|
|
|
|
b. Weight (g) |
Mean |
3.96 |
3.82 |
3.47 |
3.24* |
|
SD |
0.33 |
0.59 |
0.78 |
0.79 |
|
|
|
|
|
|
Live female fetuses |
|
|
|
|
|
a. Number |
|
148 |
115 |
125 |
138 |
|
|
|
|
|
|
b. Weight (g) |
Mean |
3.71 |
3.62 |
3.30 |
3.02* |
|
SD |
0.35 |
0.51 |
0.69 |
0.77 |
|
|
|
|
|
|
Sex Ratio - Male : Female |
|
1:1.08 |
1:0.89 |
1:1.03 |
1:0.99 |
|
|
|
|
|
|
*: Significantly different from vehicle control group.
Applicant's summary and conclusion
- Conclusions:
- NA-DETA is not a developmental toxicant. No classification is warranted.
- Executive summary:
The developmental toxicity of NA-DETA was investigated according to the OECD Guideline 414 in SD rats. The animals were treated daily from gestation day 5 to 19 and the cesarean section was performed on gestation day 20. The initial dose levels of 0, 60, 120 and 250 mg/kg/day induced clinical signs indicative of severe toxicity (including mortality) so that the dose levels were reduced to 0, 20, 40 and 80 mg/kg bw.
The NOAEL of maternal toxicity was 60/20 mg/kg/day due to the clinical signs, reduced body weight and reduced food intake in the mid and high dose groups. No effect on the maternal reproductive performance was found in all treated animals.
The NOAEL of developmental toxicity was 120/40 mg/kg/day due to the reduced mean fetal weight in high dose group. No effect on litter size was found in all treated groups.
The NOAEL of teratogenicity was 250/80 mg/kg/day as no effect was found upon skeletal and visceral observation.
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.