2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

Endpoint summary

Description of key information

Acute oral toxicity in rats (OECD 401)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

TEST MATERIAL NAME (as stated in study report): TK 12184/1 (Generic name: TGE - Phosphite)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 004-009
- Expiration date of the lot/batch: November 1984
- Purity: commercial grade

Species:

rat

Strain:

other: Rat, Tif:RAIf (SPF)

Remarks:

Fl-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 173-203 g
- Fasting period before dosing: overnight
- Housing: in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG CSwitzerland; ad libitum post dosing
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3° C
- Humidity (%): 55 ± 15%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

Dosage volume: 10 mL/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for mortality and signs and symptoms; body weights on days 1, 7, and 14.
- Necropsy of survivors performed: yes

Statistics:

Group mean body weights and standard deviations were calculated

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No morality occurred

Clinical signs:

Dyspnoea, ruffled fur and curved body position. All animals returned to normal within 11 days.

Body weight:

Mean body weights increased during the study

Gross pathology:

No gross lesions were observed

Interpretation of results:

GHS criteria not met

Remarks:

Not classified by CLP Criteria

Conclusions:

In a guideline (OECD 401) study, the acute oral lethal dose of TGE Phosphite in rats was greater than 5,000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a guideline (OECD 401) study, the acute oral lethal dose of TGE Phosphite in rats was greater than 5,000 mg/kg.

Justification for classification or non-classification

Based on the available data, TGE Phosphite is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008.