Registration Dossier

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:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Tridecylamine technical grade
- Purity approx. 95%

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals 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:
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 postdose days 7 and 8 onwards.
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

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 irritation properties of the
test substance.