Reaction mass of trientine and trientine, mono- and di-propoxylated

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: Pre-guideline and pre-GLP Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

TK 10406

IUPAC Name:

TK 10406

Test material form:

solid - liquid: suspension

Details on test material:

The test material was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 20, 30 and 40% with polyethylene glycol (PEG 400).

Test animals

Species:

rat

Strain:

other: TIF: RAC/F

Sex:

male/female

Details on test animals or test system and environmental conditions:

The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22 Î. 1°C and a relative humidity of approximately 50%. They were given water and food (NAFAG, Gossau SG, rat food) ad libitum. The rats were starved duringone night before starting the treatment.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

polyethylene glycol

Details on oral exposure:

The test material was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 20, 30 and 40% with polyethylene glycol (PEG 400).

Doses:

2150, 3170 and 4640 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

not specified

Details on study design:

The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22 Î. 1°C and a relative humidity of approximately 50%. They were given water and food (NAFAG, Gossau SG, rat food) ad libitum. The rats were starved duringone night before starting the treatment.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 500 mg/kg bw

Based on:

test mat.

Mortality:

At the end of the study on Day 7 there was a dose dependent trend evident with 0, 30 and 50% mortality at 2150, 3170 and 4640 mg/kg respectively

Gross pathology:

Congested liver was observed in animals that died during the study. No substance related gross organ changes were seen in aniamals that survived until the end of the test.

Other findings:

Within 2 to 3 hours of treatment the animals in all dosage groups showed dyspnoea, lachrymation, apathy, ruffled fur and curved position.
The surviving animals had recovered within 3 to 5 days. They were killed and autopsied after an observation period of 7 days.

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The acute oral LD 50 in rats of both sexes was observed over a period of 7 days. The LD50 was approximately 4500 mg/kg, the test material has therefore a slight acute toxicity to rats by this route of administration

Executive summary:

The test material was assessed for toxicity in an acute oral toxicity study with male and female rats. The test material was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 20, 30 and 40% with polyethylene glycol (PEG 400) and administered to the shaved back of each rat at doses of 2150, 3170 and 4640 mg/kg. Animals were observed 1, 24, 48 hours and 7 days following administration, within 2 to 3 hours of treatment the animals in all dosage groups showed dyspnoea, lachrymation, apathy, ruffled fur and curved position. The surviving animals had recovered within 3 to 5 days. They were humanely killed and autopsied after an observation period of 7 days.

The acute oral LD 50 of TK 10406 in rats of both sexes was observed over a period of 7 days the LD50 was approximately 4500 mg/kg, the compound has therefore a slight acute toxicity to rats by this route of administration.

According to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, there is no requirement for classification of the test material within the EU. Based on the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Second edition, 2007, the test material should be classified as Category 5 for acute oral toxicity.