2-Propanol, 1,1'-(tridecylimino)bis-

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. No GLP, however detailed documentation available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Principles of method if other than guideline:

5 male and 5 female rats were treated oral (gavage) with 1000, 2000, and 3160 mg/kg bw of the test substance in olive oil (5 ml/kg bw).
Signs and symptoms were recorded several times on the day at least once each workday. Check for moribund and dead animals was performed twice each workday and once on holidays. Necropsy with gross-pathological examinations was performed at the end of the 14 day observation period. Necropsy of animals that died was performed as early as possible.

GLP compliance:

no

Test type:

standard acute method

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Batch No: 97/70046

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR . K . Thomae GmbH, 7950 Bieberach, Germany
- Weight at study initiation: 190 g +/- 20%
- Fasting period before study: 16 h
- Housing: Single, in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, Germany)
- Diet: ad libitum KLIBA-Labordiaet 343, Klingenthalmuehle AG, CH-4303 Kaiseraugust, Switzerland
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Dose volume applied: 5 ml/kg bw

Doses:

1000, 2000, 3160 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administation, thereafter at least once each workday. Check for morbidity and dead animals twice each workday and once on holidays. Weighing on day 7 and 13.
- Necropsy of survivors performed: yes

Statistics:

According to: Finney, D.J ., Probit Analysis, Cambridge University Press, 3rd ED., 1971

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 510 mg/kg bw

95% CL:

1 980 - 3 200

Mortality:

Dose group (mg/kg):
1000: no mortalities occured.
2000: no male animals died. 2/5 females died within 2-7 days after application. No further deaths until end of observation.
3160: 3/5 males died within 2-7 days after application. No further deaths until end of observation. 1 female died at the 2nd day after application. The remaining 4 females died within 2-7 days after application. No survivors in the female group after 7 days.

Clinical signs:

Dyspnea, Apathy, Aggressiveness, Staggering, Spastic Gait, Piloerrection, Diarrhea, Alopecia, Exsiccosis could be observed. Reversibility and further information see table 1.

Body weight:

There was a constant body weight gain.

Gross pathology:

Animals that died (male and female):
general congestion
grandular stomach: slight reddened area or bloody erosions.
Swall intestines: diarrhoeal contents, in few cases reddened mucosa.
Cecum: reddened, with liquid hemorrhagic contents.
Animals that were sacrificed at the end of the observation period (male + female): No pathologic findings noted.

Any other information on results incl. tables

Table 1: Appearance of Clinical signs within the different dose groups:

Reversibility of Symptoms
	1000 mg/kg bw		2000 mg/kg bw		3160 mg/kg bw
	male	female	male	female	male	female
Dyspnea	5d-6d	5d-9d		5d-7d	5d-9d	1d
Apathy	5d-6d	5d-7d			8d-9d	1d
Aggressiveness					5d-7d
Staggering		5d-7d			5d-9d	1d
Spatic Gait				5d-9d	5d-7d
Piloerrection	5d-7d	5d-9d		5d-9d	1d-14d	1d
Diarrhea					5d-7d	30min-1h
Alopecia					8d-14d
Exsiccosis				5d-9d
Impaired general state			2d	2d
Poor general State	5d-6d	5d-7d		5d-9d	5d-9d	1d

d = days