Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 15 March 1974 and 18 April 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Valid and conclusive pre-GLP study comparable to guideline, basic data reported

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

Necropsy omitted, administered volume in excess of guideline recommendations

GLP compliance:

no

Remarks:

The experiment was performed before the first GLP standard was defined by FDA in 1976, therefore no formal GLP was possible. Nonetheless it can be assumed that comparable standards applied as the test was conducted in a specialized laboratory.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

EC Number:

300-326-6

EC Name:

Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

Cas Number:

93925-25-8

Molecular formula:

Complex

IUPAC Name:

Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

other: Sherman-Wistar (albino)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Animals weighed between 200 and 250 g.
- Fasting period before study: Test animals were fasted overnight (24 h) before dose administration.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2, 4, 8, 16, or 32 mL/kg; given the submission item relative density value 910 kg/m³, the doses correspond to 1820, 3640, 7280, 14,560 and 29,120 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 d
- Frequency of observations and weighing: Daily observation, weighing at study initiation only
- Necropsy of survivors performed: No
- Other examinations performed: The animals were observed for 14 d for signs of toxicity and mortality.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 32 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Mortality: 1/5 and 2/5 at 16 and 32 mL/kg, respectively

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 29 120 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Converted using the density value 910 kg/m³

Effect levels 3

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 7 280 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No difference to control

Mortality:

At 16 mL/kg bw one test animal was found dead on day 2.
At 32 mL/kg bw one test animal was found dead on day 1 and a second one on day 2.

Clinical signs:

other: No observations

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Not acute toxic, LD0 ≥ 8 mL/kg bw or ≥ 7280 mg/kg bw and LD 50 > 32 mL/kg bw or > 29,120 mg/kg bw

Executive summary:

The acute toxicity of the test item by oral route was investigated in a pre-GLP study using male albino Sherman-Wistar rats according to a protocol comparable to the OECD TG 401 (1987) standards. At variance to the guideline no necropsy was performed and the test item was applied in a volume exceeding 1 mL per 100 g bw. The experiment was performed before the first GLP standard was defined by FDA in 1976, therefore no formal GLP was possible. Nonetheless it can be assumed that comparable standards applied as the test was conducted in a specialized laboratory. The reporting is limited but sufficient information is given. The experiment is deemed valid, conclusive and thus suitable for assessment with minor restrictions.

Groups of test animals, each consisting of 5 individuals weighing between 200 and 250 g were fasted overnight and administered 2, 4, 8, 16 or 32 mL/kg by stomach tube, which corresponds to 1820, 3640, 7280, 14,560 and 29,120 mg/kg bw. The animals were observed for 14 d post exposure for signs of toxicity and mortality.

Mortality was observed at 16 and 32 mL/kg, where 1 and 2 animals died, respectively, until day 2. No observation of sublethal effects was made. Therefore the LD50 is > 32 mL/kg bw or > 29,120 mg/kg bw. At 8 mL/kg bw or 7280 mg/kg bw no mortality occurred, which means that the LD0 (discriminating dose) can be assigned to be greater or equal to this level.

In summary no effects were observed in the classifiable range up to 2000 mg/kg bw (CLP) or even 5000 mg/kg bw (GHS). Therefore, on the basis of this study, classification is not required for the test item in accordance with EU CLP Regulation (EC) No 1272/2008 and the absence of acute oral toxicity is evidenced.