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EC number: 701-381-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (short observation period, brief report)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- observation period only 7 days
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Amines, C11-C13 (linear and branched) alkyl
- EC Number:
- 701-381-2
- IUPAC Name:
- Amines, C11-C13 (linear and branched) alkyl
- Details on test material:
- - Tridecylamine technical grade
- Purity approx. 95%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Gassner
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous emulsion containing polysaccharide (traganth)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.1-20% - Doses:
- 200, 400, 500, 640, 800, 1000, 1250, 1600 µl/kg bw
- No. of animals per sex per dose:
- 10
- Details on study design:
- - Duration of observation period following administration: 7 days (400-1600 µl/kg bw) and 10 days (200 µl/kg bw)
- Frequency of observations: at least daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs of toxicity
- LD50 was calculated according to Litchfield-Wilcoxon
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- 820 mg/kg bw
- Mortality:
- First deaths were noted 24 h postdose. Deaths occurred also at later time points, e.g. between days 2 and 7 postdose, in the groups receiving 640 µl/kg bw and higher. In the group at 200 µl/kg bw one death was noted between postdose days 7 and 10.
Higher doses with 10 or 20 vol% of tridecylamine were 100% lethal within 7 days. - Clinical signs:
- other: Dyspnea and restlessness, salivation piloerection, hunched posture were reportedly noted at all dose levels within minutes after dosing. Forced breathing and red encrusted eyes and noses were noted during the days after treatment. No signs were seen from
- Gross pathology:
- Findings were not discriminated according to dose level.
Findings and incidences in animals that died:
Snouts: bloody smeared snouts (9 cases); bloody smeared and encrusted snouts (22 cases). Ani: bloody smeared ani- diarrhea (7 cases). Stomach, intestine: stomachs filled with TS (3 cases); stomach ectasia (8 cases); distended stomach (18 cases); ectasia in upper gut (1 case); atonic GI tracts (37 cases); putrefaction (2 cases); 1 animal without findings.
Findings and incidences in animals that were sacrificed:
No findings except 2 cases of adhesions.
Any other information on results incl. tables
Mortalities:
Dose (µl/kg bw) |
Test substance (%) |
Mortalities 7 days postdose |
||
Males |
Females |
Total |
||
200 |
2 |
0/10 |
1/10 |
1/20 |
400 |
4 |
0/10 |
0/10 |
0/20 |
500 |
8 |
1/10 |
0/10 |
1/20 |
640 |
8 |
3/10 |
5/10 |
8/20 |
800 |
8 |
0/10 |
8/10 |
8/20 |
1000 |
10 |
1/10 |
10/10 |
11/20 |
1250 |
10 |
10/10 |
10/10 |
20/20 |
1600 |
20 |
10/10 |
10/10 |
20/20 |
The combined LD50-value was estimated to be 1000 µl/kg bw. This corresponds to ca. 820 mg/kg bw. The acute toxicity was higher in females (LD50 estimated at 520 mg/kg bw) than in males.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- There is a steep dose-mortality relation. Combined mortalities of 40 or 55% were noted in the dose range 640 to 1000 µl/kg bw, with 8 - 10 vol% tridecylamine in the administered dose.
The acute toxicity was higher in females (LD50 estimated at 520 mg/kg bw) than in males. The calculated combined male and female LD50-value was approx. 820 mg/kg bw.
Stomach, intestine, and snouts were affected. The symptoms suggest to be related to the corrosive properties of the test substance.
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