Reaction products of tetrakis(hydroxymethyl)phosphonium chloride, urea and tetradecan-1-amine

Acute Toxicity: oral

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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: Read-across from supporting substance. Similar to OECD guideline 420, but main study should have followed up non toxic dose of 50 mg/kg with test at 300 mg/kg.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Reason / purpose for cross-reference:

read-across source

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

yes

Remarks:

Non toxic dose of 50 mg/kg should be followed by test at 300 mg/kg

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

other: Liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zeneca Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK
- Age at study initiation: young adults
- Weight at study initiation: 202-247 g(m) 191-211 (f)
- Fasting period before study: up to 24 hours
- Housing: 5 rats per cage, separate sexes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: not available (July-August 1995)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Deionised Water

Doses:

Preliminary study: 50, 200, 500 mg/kg (corrected for water content of 26.1%)
Main study: 50 mg/kg (corrected for water content of 26.1%)

No. of animals per sex per dose:

Preliminary sighting study: 3 (female)
Main study: 5 (male)
Main study: 5 (female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 3 times during fist 24 hours, then once or twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

Species/strain: Rat (Wistar)
200 mg/kg bw: Evident toxicity: No; Mortality: No
500 mg/kg. Mortality: Yes, day 2

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

50 mg/kg bw

Based on:

other: test substance corrected for water content of 26.1%

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

200 mg/kg bw

Based on:

other: test substance corrected for water content of 26.1%

Mortality:

Preliminary study: 500 mg/kg: 1/1 (f)
Main study: 50 mg/kg: 1/10 (f) but not conidered due to treatment.

Clinical signs:

other: Signs of toxicity: There were no signs of evident toxicity at any time point.

Gross pathology:

Effects on organs:
No treatment-related macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The minimum lethal dose of the test substance was 500 mg/kg. The test substance is considered Acute category 4 (harmful) according to the criteria of EC Reg. 1272/2008.

Executive summary:

ITC 826 concentrate was tested for acute oral toxicity using the fixed dose procedure. In a preliminary study, single animals received a single oral dose of 50, 200 or 500 mg/kg (corrected for water content) and were assessed daily for signs of systemic toxicity. There was no mortality or clinical signs at 50 mg/kg. No mortality and slight clinical signs were observed at 200 mg/kg. The female dosed at 500 mg/kg was found dead on day 2.

A single fixed dose level of 50 mg/kg was selected for the main study. A group of 5 males and 5 females was dosed. Animals surviving to the end of the study were killed. All animals were subjected to a macroscopic post-mortem examination.

here were no signs of evedent toxicity at 50 mg/kg. One femal rat was found dead on day 5 but this mortality was considered incidental to treatment since no clinical abnormalities were present in this animal prior to death.

The discriminating dose level was 50 mg/kg. The minimum lethal dose was 500 mg/kg..